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A randomized clinical trial of buprenorphine for prisoners: Findings at 12-months post-release.

January 21, 2017 - 6:07am

A randomized clinical trial of buprenorphine for prisoners: Findings at 12-months post-release.

Drug Alcohol Depend. 2017 Jan 11;172:34-42

Authors: Gordon MS, Kinlock TW, Schwartz RP, O'Grady KE, Fitzgerald TT, Vocci FJ

Abstract
BACKGROUND: This study examined whether starting buprenorphine treatment prior to prison and after release from prison would be associated with better drug treatment outcomes and whether males and females responded differently to the combination of in-prison treatment and post-release service setting.
METHODS: Study design was a 2 (In-Prison Treatment: Condition: Buprenorphine Treatment: vs. Counseling Only)×2 [Post-Release Service Setting Condition: Opioid Treatment: Program (OTP) vs. Community Health Center (CHC)]×2 (Gender) factorial design. The trial was conducted between September 2008 and July 2012. Follow-up assessments were completed in 2014. Participants were recruited from two Baltimore pre-release prisons (one for men and one for women). Adult pre-release prisoners who were heroin-dependent during the year prior to incarceration were eligible. Post-release assessments were conducted at 1, 3, 6, and 12-month following prison release.
RESULTS: Participants (N=211) in the in-prison treatment condition effect had a higher mean number of days of community buprenorphine treatment compared to the condition in which participants initiated medication after release (P=0.005). However, there were no statistically significant hypothesized effects for the in-prison treatment condition in terms of: days of heroin use and crime, and opioid and cocaine positive urine screening test results (all Ps>0.14) and no statistically significant hypothesized gender effects (all Ps>0.18).
CONCLUSIONS: Although initiating buprenorphine treatment in prison compared to after-release was associated with more days receiving buprenorphine treatment in the designated community treatment program during the 12-months post-release assessment, it was not associated with superior outcomes in terms of heroin and cocaine use and criminal behavior.

PMID: 28107680 [PubMed - as supplied by publisher]

NON-BUPRENORPHINE OPIOID UTILIZATION AMONG PATIENTS USING BUPRENORPHINE.

January 21, 2017 - 6:07am

NON-BUPRENORPHINE OPIOID UTILIZATION AMONG PATIENTS USING BUPRENORPHINE.

Addiction. 2017 Jan 20;:

Authors: Daubresse M, Saloner B, Pollack HA, Caleb Alexander G

Abstract
BACKGROUND AND AIMS: Buprenorphine is commonly used to treat opioid use disorder, however, non-buprenorphine prescription opioid use among these patients is not well defined. We sought to estimate the prevalence of non-buprenorphine opioid use among incident buprenorphine users and quantify levels of opioid use prior to, during and after the first treatment episode.
DESIGN: We used QuintilesIMS anonymized, individual-level, all-payer pharmacy claims to identify incident users of buprenorphine between January 2010 through July 2012 from a large cohort of approximately 50 million patients filling two or more prescriptions for any opioid during any calendar year between 2006 and 2013 in eleven states of interest.
SETTING: Eleven states within the U.S.
PARTICIPANTS: Of the individuals who met our inclusion criteria (N = 38,096), 55% were female and 50% were between 29 and 54 years of age. Median length of the first treatment episode was 55 days (interquartile range [IQR], 28 to 168 days).
MEASUREMENTS: We calculated four measures of non-buprenorphine opioid use: (1) number of prescriptions, (2) quantity dispensed, (3) days supply and (4) total morphine milligram equivalents (MME), before, during and after the first treatment episode. Our primary outcome was the MME per opioid day supplied during each time period.
FINDINGS: Approximately two-fifths (43%) of buprenorphine recipients filled an opioid prescription during the treatment episode and two-thirds (67%) filled an opioid prescription following treatment. The mean total of MME per opioid day supplied 12 months declined from 57 mg/per day (95% CI 57, 58) prior to treatment to 54 mg/per day (95% CI 54, 55) during the treatment episode, then remained constant at 55 mg/per day (95% CI 54, 56) following the treatment episode.
CONCLUSIONS: The use of buprenorphine for the treatment of opioid use disorder has increased markedly in the United States. However, a substantial proportion of patients fill prescriptions for non-buprenorphine opioids during and following such treatment.

PMID: 28107580 [PubMed - as supplied by publisher]

Treatment Outcome Comparison Between Telepsychiatry and Face-to-face Buprenorphine Medication-assisted Treatment for Opioid Use Disorder: A 2-Year Retrospective Data Analysis.

January 21, 2017 - 6:07am

Treatment Outcome Comparison Between Telepsychiatry and Face-to-face Buprenorphine Medication-assisted Treatment for Opioid Use Disorder: A 2-Year Retrospective Data Analysis.

J Addict Med. 2017 Jan 19;:

Authors: Zheng W, Nickasch M, Lander L, Wen S, Xiao M, Marshalek P, Dix E, Sullivan C

Abstract
OBJECTIVES: To retrospectively review clinic records to assess the difference between face-to-face and telepsychiatry buprenorphine medication-assisted treatment (MAT) programs for the treatment of opioid use disorder on 3 outcomes: additional substance use, average time to achieve 30 and 90 consecutive days of abstinence, and treatment retention rates at 90 and 365 days.
METHODS: Medical records of patients (N = 100) who were participating in telepsychiatry and in face-to-face group-based outpatient buprenorphine MAT programs were reviewed and assessed using descriptive statistical analysis.
RESULTS: In comparison with the telepsychiatry MAT group, the face-to-face MAT group showed no significant difference in terms of additional substance use, time to 30 days (P = 0.09) and 90 days of abstinence (P = 0.22), or retention rates at 90 and 365 days (P = 0.99).
CONCLUSIONS: We did not find any significant statistical difference between telepsychiatry buprenorphine MAT intervention through videoconference and face-to-face MAT treatment in our Comprehensive Opioid Addiction Treatment model for individuals diagnosed with opioid use disorder in terms of additional substance use, average time to 30 and 90 days of abstinence, and treatment retention rates.

PMID: 28107210 [PubMed - as supplied by publisher]

Defined daily doses (DDD) do not accurately reflect opioid doses used in contemporary chronic pain treatment.

January 20, 2017 - 6:03am
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Defined daily doses (DDD) do not accurately reflect opioid doses used in contemporary chronic pain treatment.

Pharmacoepidemiol Drug Saf. 2017 Jan 19;:

Authors: Nielsen S, Gisev N, Bruno R, Hall W, Cohen M, Larance B, Campbell G, Shanahan M, Blyth F, Lintzeris N, Pearson S, Mattick R, Degenhardt L

Abstract
OBJECTIVE: To assess how well the defined daily dose (DDD) metric reflects opioid utilisation among chronic non-cancer pain patients.
DESIGN: Descriptive, cross-sectional study, utilising a 7-day medication diary.
SETTING: Community-based treatment settings, Australia.
SUBJECTS: A sample of 1101 people prescribed opioids for chronic non-cancer pain.
METHODS: Opioid dose data was collected via a self-completed 7-day medication diary capturing names, strengths and doses of each medication taken in the past week. Median daily dose was calculated for each opioid. Comparisons were made to the World Health Organization's (WHO) DDD metric.
RESULTS: WHO DDDs ranged from 0.6 to 7.1 times the median opioid doses used by the sample. For transdermal fentanyl and oral hydromorphone, the median dose was comparable with the DDD. The DDD for methadone was 0.6 times lower than the median doses used by this sample of chronic pain patients. In contrast, the DDD for oxycodone and transdermal buprenorphine, the most commonly used strong opioids for chronic pain in Australia, was two to seven times higher than actual doses used.
CONCLUSIONS: For many opioids, there are key differences between the actual doses used in clinical practice and the WHO's DDDs. The interpretation of opioid utilisation studies using population-level DDDs may be limited, and a recalibration of the DDD for many opioids or the reporting of opioid utilisation in oral morphine equivalent doses is recommended. Copyright © 2017 John Wiley & Sons, Ltd.

PMID: 28101968 [PubMed - as supplied by publisher]

Rifampicin decreases exposure to sublingual buprenorphine in healthy subjects.

January 18, 2017 - 1:56pm
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Rifampicin decreases exposure to sublingual buprenorphine in healthy subjects.

Pharmacol Res Perspect. 2016 Dec;4(6):e00271

Authors: Hagelberg NM, Fihlman M, Hemmilä T, Backman JT, Laitila J, Neuvonen PJ, Laine K, Olkkola KT, I Saari T

Abstract
Buprenorphine is mainly metabolized by the cytochrome P450 (CYP) 3A4 enzyme. The aim of this study was to evaluate the role of first-pass metabolism in the interaction of rifampicin and analgesic doses of buprenorphine. A four-session paired cross-over study design was used. Twelve subjects ingested either 600 mg oral rifampicin or placebo once daily in a randomized order for 7 days. In the first part of the study, subjects were given 0.6-mg (placebo phase) or 0.8-mg (rifampicin phase) buprenorphine sublingually on day 7. In the second part of the study, subjects received 0.4-mg buprenorphine intravenously. Plasma concentrations of buprenorphine and urine concentrations of buprenorphine and its primary metabolite norbuprenorphine were measured over 18 h. Adverse effects were recorded. Rifampicin decreased the mean area under the dose-corrected plasma concentration-time curve (AUC 0-18) of sublingual buprenorphine by 25% (geometric mean ratio (GMR): 0.75; 90% confidence interval (CI) of GMR: 0.60, 0.93) and tended to decrease the bioavailability of sublingual buprenorphine, from 22% to 16% (P = 0.31). Plasma concentrations of intravenously administered buprenorphine were not influenced by rifampicin. The amount of norbuprenorphine excreted in the urine was decreased by 65% (P < 0.001) and 52% (P < 0.001) after sublingual and intravenous administration, respectively, by rifampicin. Adverse effects were frequent. Rifampicin decreases the exposure to sublingual but not intravenous buprenorphine. This can be mainly explained by an enhancement of CYP3A-mediated first-pass metabolism, which sublingual buprenorphine only partially bypasses. Concomitant use of rifampicin and low-dose sublingual buprenorphine may compromise the analgesic effect of buprenorphine.

PMID: 28097004 [PubMed - in process]

Impact of treatment for opioid dependence on fatal drug-related poisoning: a national cohort study in England.

January 18, 2017 - 1:56pm
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Impact of treatment for opioid dependence on fatal drug-related poisoning: a national cohort study in England.

Addiction. 2016 Feb;111(2):298-308

Authors: Pierce M, Bird SM, Hickman M, Marsden J, Dunn G, Jones A, Millar T

Abstract
AIMS: To compare the change in illicit opioid users' risk of fatal drug-related poisoning (DRP) associated with opioid agonist pharmacotherapy (OAP) and psychological support, and investigate the modifying effect of patient characteristics, criminal justice system (CJS) referral and treatment completion.
DESIGN: National data linkage cohort study of the English National Drug Treatment Monitoring System and the Office for National Statistics national mortality database. Data were analysed using survival methods.
SETTING: All services in England that provide publicly funded, structured treatment for illicit opioid users.
PARTICIPANTS: Adults treated for opioid dependence during April 2005 to March 2009: 151,983 individuals; 69% male; median age 32.6 with 442,950 person-years of observation.
MEASUREMENTS: The outcome was fatal DRP occurring during periods in or out of treatment, with adjustment for age, gender, substances used, injecting status and CJS referral.
FINDINGS: There were 1499 DRP deaths [3.4 per 1000 person-years, 95% confidence interval (CI) = 3.2-3.6]. DRP risk increased while patients were not enrolled in any treatment [adjusted hazard ratio (aHR) = 1.73, 95% CI = 1.55-1.92]. Risk when enrolled only in a psychological intervention was double that during OAP (aHR = 2.07, 95% CI = 1.75-2.46). The increased risk when out of treatment was greater for men (aHR = 1.88, 95% CI = 1.67-2.12), illicit drug injectors (aHR = 2.27, 95% CI = 1.97-2.62) and those reporting problematic alcohol use (aHR = 2.37, 95% CI = 1.90-2.98).
CONCLUSIONS: Patients who received only psychological support for opioid dependence in England appear to be at greater risk of fatal opioid poisoning than those who received opioid agonist pharmacotherapy.

PMID: 26452239 [PubMed - indexed for MEDLINE]

Investigational drugs in recent clinical trials for treatment-resistant depression.

January 17, 2017 - 6:48am

Investigational drugs in recent clinical trials for treatment-resistant depression.

Expert Rev Neurother. 2017 Jan 16;:

Authors: Garay RP, Zarate CA, Charpeaud T, Citrome L, Correll CU, Hameg A, Llorca PM

Abstract
INTRODUCTION: The authors describe the medications for treatment-resistant depression (TRD) in phase II/III of clinical development in the EU and US and provide an opinion on how current treatment can be improved in the near future. Areas covered: Sixty-two trials were identified in US and EU clinical trial registries that included six investigational compounds in recent phase III development and 12 others in recent phase II clinical trials. Glutamatergic agents have been the focus of many studies. A single intravenous dose of the glutamatergic modulator ketamine produces a robust and rapid antidepressant effect in persons with TRD; this effect continues to remain significant for 1 week. This observation was a turning point that opened the way for other, more selective glutamatergic modulators (intranasal esketamine, AVP-786, AVP-923, AV-101, and rapastinel). Of the remaining compounds, monoclonal antibodies open highly innovative therapeutic options, based on new pathophysiological approaches to depression. Expert commentary: Promising new agents are emerging for TRD treatment. Glutamatergic modulators likely represent a very promising alternative to monoaminergic antidepressant monotherapy. We could see the arrival of the first robust and rapid acting antidepressant drug in the near future, which would strongly facilitate the ultimate goal of recovery in persons with TRD.

PMID: 28092469 [PubMed - as supplied by publisher]

Prenatal treatment for opioid dependency: observations from a large inner-city clinic.

January 15, 2017 - 6:37am
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Prenatal treatment for opioid dependency: observations from a large inner-city clinic.

Addict Sci Clin Pract. 2017 Jan 13;12(1):5

Authors: Saia K, Bagley SM, Wachman EM, Patel PP, Nadas MD, Brogly SB

Abstract
BACKGROUND: The objective of this study was to review changes in the prevalence of opioid use disorder in pregnancy, and to describe the prenatal care and neonatal outcomes following the implementation of buprenorphine treatment at a large US obstetrical clinic during the on-going opioid epidemic.
METHODS: We conducted a retrospective cohort study of 310 women (332 pregnancies) with opioid use disorders and their neonates delivered between June 2006 and December 2010 at an obstetrical clinic in the US. Trends in patient volume, characteristics and outcomes by calendar year were assessed using the Cochran-Armitage test and linear regression.
RESULTS: There was an almost two-fold increase in the volume of pregnant women treated annually from 2006 through 2010. Most women were treated with methadone (74%), with buprenorphine becoming more common over calendar time: 3.0% in 2006 to 41% in 2010. The mean dose of buprenorphine at delivery was: 11.4 mg in 2007, 14.1 mg in 2008, 14.1 mg in 2009, and 16.8 mg in 2010; an average increase of 2.1 mg year. There were no differences in mean methadone dose over time. From 2006 to 2010 there were increases in the prevalence of prescribed concomitant psychotropic medications and vaginal deliveries, and in the proportion of neonates treated pharmacologically for neonatal abstinence syndrome (NAS). NAS pharmacologic management also varied by calendar year with more use of neonatal morphine and clonidine in later years.
CONCLUSIONS: The number of mother-infant pairs increased significantly from 2006 to 2010 and the clinical characteristics of these patients changed over time. Our experience reflects the rising increase in opioid use disorders in pregnancy and NAS, mandating the need for expansion of comprehensive prenatal care options for these women and their children.

PMID: 28086944 [PubMed - in process]

Systemic and individual factors in the buprenorphine treatment-seeking process: a qualitative study.

January 15, 2017 - 6:37am
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Systemic and individual factors in the buprenorphine treatment-seeking process: a qualitative study.

Subst Abuse Treat Prev Policy. 2017 Jan 11;12(1):3

Authors: Hewell VM, Vasquez AR, Rivkin ID

Abstract
BACKGROUND: Opioid use is a significant problem in Alaska. Medication-assisted treatment for opioid use, including buprenorphine, reduces withdrawal symptoms and the harm associated with opioid abuse. Understanding consumers' treatment-seeking process is important for addressing barriers to treatment, facilitating effective service utilization, and informing policy.
METHODS: To understand treatment-seeking behavior, we examined the attitudes, perceptions, and knowledge of those who would benefit from the medication-assisted treatment (MAT) buprenorphine. Qualitative data from 2 focus groups (each including 4 participants) and 3 in-depth interviews with people who have used or considered using buprenorphine in treatment for an opioid use disorder were analyzed using grounded theory and directed content analysis approaches.
RESULTS: Key findings suggest that individual (withdrawal process, individual motivation) and systemic (sociocultural, political, societal values) factors frame the treatment seeking process. Participants' progress on the treatment-seeking road was affected by models of addiction and MAT, which related to facilitators and barriers encountered in seeking treatment (e.g. support, resources, treatment structure). These factors shaped the longer-term road to recovery, which was seen as on ongoing process.
CONCLUSIONS: The findings of this study suggest it is crucial for interventionists to take a contextual approach that considers individual and systemic factors involved in opioid addiction, treatment, and recovery. This study highlights ways policy makers and treatment providers can address the barriers consumers face in their treatment-seeking process in order to increase treatment access.

PMID: 28086837 [PubMed - in process]

Prescription opioid abuse in prison settings: A systematic review of prevalence, practice and treatment responses.

January 14, 2017 - 6:30am

Prescription opioid abuse in prison settings: A systematic review of prevalence, practice and treatment responses.

Drug Alcohol Depend. 2016 Dec 14;171:122-131

Authors: Bi-Mohammed Z, Wright NM, Hearty P, King N, Gavin H

Abstract
BACKGROUND: To systematically review the quantitative and qualitative evidence base pertaining to the prevalence, practice of, and treatment response to the diversion of prescribed opiates in the prison setting.
METHODS: Medline, Embase, CINAHL, PsycINFO, Google Scholar, ASSIA and Science Direct databases were searched for papers from 1995 to the present relevant to the abuse of prescribed opiate medication. Identified journals and their reference lists were hand searched for other relevant articles. Of the abstracts identified as relevant, full text papers were retrieved and critiqued against the inclusion criteria for the review.
RESULTS: Three hundred and fifty-five abstracts were identified, leading to 42 full-text articles being retrieved. Of those, 10 papers were included in the review. Significant differences in abuse behaviours between different countries were reported. However, a key theme emerged from the data regarding a culture of nasal administration of prescribed sublingual buprenorphine within some prisons due to both reduced prevalence of injection within prison and reduced supplies of illicit drugs within prison. The buprenorphine/naloxone preparation appears to be less amenable to abuse. The review highlighted a paucity of empirical research pertaining to both prevalence of the phenomenon and treatment responses.
CLINICAL AND RESEARCH IMPLICATIONS: Healthcare providers within prisons need to prescribe opioids in the least abuseable preparation since the risk of abuse is significant, despite widespread processes of supervised dispensing. Prescription medication abuse is not limited to opioids and the predominant drug of abuse in an individual prison can rapidly change according to availability.

PMID: 28086177 [PubMed - as supplied by publisher]

The comparative safety of buprenorphine versus methadone in pregnancy-what about confounding?

January 12, 2017 - 6:19am

The comparative safety of buprenorphine versus methadone in pregnancy-what about confounding?

Addiction. 2016 Dec;111(12):2130-2131

Authors: Brogly SB, Saia K, Hernández-Diaz S, Werler M, Sebastiani P

PMID: 28075537 [PubMed - in process]

Response to Smith and Brogly et al. commentaries on Zedler et al.

January 12, 2017 - 6:19am

Response to Smith and Brogly et al. commentaries on Zedler et al.

Addiction. 2016 Dec;111(12):2131-2133

Authors: Joyce AR, Zedler BK, Amick HR, Murrelle EL, Jones HE

PMID: 28075535 [PubMed - in process]

Is Kratom the New &#039;Legal High&#039; on the Block?: The Case of an Emerging Opioid Receptor Agonist with Substance Abuse Potential.

January 11, 2017 - 7:00am

Is Kratom the New 'Legal High' on the Block?: The Case of an Emerging Opioid Receptor Agonist with Substance Abuse Potential.

Pain Physician. 2017 Jan-Feb;20(1):E195-E198

Authors: Chang-Chien GC, Odonkor CA, Amorapanth P

Abstract
Kratom is an unscheduled opioid receptor agonist that comes in the form of dietary supplements currently being abused by chronic pain patients on prescription opioids. Active alkaloids isolated from kratom such as mitragynine and 7-hydroxymitragynine are thought to act on mu- and delta-opioid receptors as well as alpha-2 adrenergic and 5-HT2A receptors. Animal studies suggest that kratom may be more potent than morphine. Consequently, kratom consumption produces analgesic and euphoric feelings among users. In particular, some chronic pain patients on opioids take kratom to counteract the effects of opioid withdrawal. Although the Food and Drug Administration has banned its use as a dietary supplement, kratom continues to be widely available and easily accessible on the Internet at much less expensive rates than some opioid replacement therapies like buprenorphine. There are no federal regulations monitoring the sale and distribution of this drug, yet kratom has been associated with severe signs and symptoms such as hallucinations, delusions, depressions, myalgias, chills, nausea/vomiting, respiratory hepatoxicity, seizures, coma, and death. A search of the pain literature shows past research has not described the use and potential deleterious effects of this drug. Many pain physicians are not familiar with kratom and as providers who take care of high-risk chronic pain patients using prescribed opioids, knowledge of current unregulated opioid receptor agonists with abuse potential is of paramount importance. The goal of this article is to introduce kratom to pain specialists and to spur a conversation on how pain physicians may take the lead to help curb the opioid abuse and overdose epidemic. Further studies may be required to help better understand the clinical and long-term effects of kratom use among chronic pain patients.Key words: Opioid receptor agonist, Kratom, Mitragynine, opioid overdose, chronic pain, substance abuse.

PMID: 28072812 [PubMed - in process]

Pharmacokinetic Evaluation of Once-Weekly and Once-Monthly Buprenorphine Subcutaneous Injection Depots (CAM2038) Versus Intravenous and Sublingual Buprenorphine in Healthy Volunteers Under Naltrexone Blockade: An Open-Label Phase 1 Study.

January 11, 2017 - 7:00am
Related Articles

Pharmacokinetic Evaluation of Once-Weekly and Once-Monthly Buprenorphine Subcutaneous Injection Depots (CAM2038) Versus Intravenous and Sublingual Buprenorphine in Healthy Volunteers Under Naltrexone Blockade: An Open-Label Phase 1 Study.

Adv Ther. 2017 Jan 09;:

Authors: Albayaty M, Linden M, Olsson H, Johnsson M, Strandgården K, Tiberg F

Abstract
INTRODUCTION: CAM2038 q1w (once weekly) and q4w (once monthly) are investigational buprenorphine subcutaneous (SC) formulations based on FluidCrystal(®) injection depot technology. These two drug products are being developed for opioid dependence treatment, with a target for once-weekly and once-monthly SC dosing. The rationale for developing two products with different dosing frequencies is that treatment strategies/routines, and hence different treatment preferences, can vary between patients, different stages of opioid maintenance treatment, and countries. This study evaluated the pharmacokinetics and safety of buprenorphine and norbuprenorphine following administration of CAM2038 q1w or q4w versus active controls.
METHODS: Healthy volunteers were randomized to five treatment groups. All received a single intravenous dose of buprenorphine 600 µg, followed post-washout by a single dose of CAM2038 q4w 96 mg, a single dose of CAM2038 q4w 192 mg, or sublingual buprenorphine 8, 16, or 24 mg daily for 7 days, followed post-washout by a single dose of CAM2038 q4w 64 or 128 mg or four repeated weekly doses of CAM2038 q1w 16 mg. All subjects received daily naltrexone.
RESULTS: Eighty-seven subjects were randomized. Median buprenorphine t max after CAM2038 q4w was 4-10 h (24 h for CAM2038 q1w); mean terminal half-life was 19-25 days (5 days for CAM2038 q1w). CAM2038 q4w showed dose-proportional buprenorphine release, with similar exposure to repeat-dose CAM2038 q1w at comparable monthly dose level. Both CAM2038 formulations showed complete absolute bioavailability of buprenorphine and 5.7- to 7.7-fold greater buprenorphine bioavailability versus sublingual buprenorphine. CAM2038 q1w and q4w were well tolerated; subjects' acceptance was higher for CAM2038 than for sublingual buprenorphine 1 h post-dose.
CONCLUSIONS: The pharmacokinetic profiles of CAM2038 q1w and q4w versus sublingual buprenorphine support expected treatment efficacy with once-weekly and once-monthly dosing, respectively. CAM2038 formulations were safe and showed good local tolerability.
TRIAL REGISTRATION: ISRCTN24987553.
FUNDING: Camurus AB.

PMID: 28070862 [PubMed - as supplied by publisher]

Long-Acting Injectable Naltrexone Induction: A Randomized Trial of Outpatient Opioid Detoxification With Naltrexone Versus Buprenorphine.

January 11, 2017 - 7:00am
Related Articles

Long-Acting Injectable Naltrexone Induction: A Randomized Trial of Outpatient Opioid Detoxification With Naltrexone Versus Buprenorphine.

Am J Psychiatry. 2017 Jan 10;:appiajp201616050548

Authors: Sullivan M, Bisaga A, Pavlicova M, Choi CJ, Mishlen K, Carpenter KM, Levin FR, Dakwar E, Mariani JJ, Nunes EV

Abstract
OBJECTIVE: At present there is no established optimal approach for transitioning opioid-dependent adults to extended-release injection naltrexone (XR-naltrexone) while preventing relapse. The authors conducted a trial examining the efficacy of two methods of outpatient opioid detoxification for induction to XR-naltrexone.
METHOD: Participants were 150 opioid-dependent adults randomly assigned 2:1 to one of two outpatient detoxification regimens, naltrexone-assisted detoxification or buprenorphine-assisted detoxification, followed by an injection of XR-naltrexone. Naltrexone-assisted detoxification lasted 7 days and included a single day of buprenorphine followed by ascending doses of oral naltrexone along with clonidine and other adjunctive medications. Buprenorphine-assisted detoxification included a 7-day buprenorphine taper followed by a week-long delay before administration of XR-naltrexone, consistent with official prescribing information for XR-naltrexone. Participants from both groups received behavioral therapy focused on medication adherence and a second dose of XR-naltrexone.
RESULTS: Compared with participants in the buprenorphine-assisted detoxification condition, participants assigned to naltrexone-assisted detoxification were significantly more likely to be successfully inducted to XR-naltrexone (56.1% compared with 32.7%) and to receive the second injection at week 5 (50.0% compared with 26.9%). Both models adjusted for primary type of opioid use, route of opioid administration, and morphine equivalents at baseline.
CONCLUSIONS: These results demonstrate the safety, efficacy, and tolerability of low-dose naltrexone, in conjunction with single-day buprenorphine dosing and adjunctive nonopioid medications, for initiating adults with opioid dependence to XR-naltrexone. This strategy offers a promising alternative to the high rates of attrition and relapse currently observed with agonist tapers in both inpatient and outpatient settings.

PMID: 28068780 [PubMed - as supplied by publisher]

Assessment of abuse liability of Tramadol among experienced drug users: Double-blind crossover randomized controlled trial.

January 7, 2017 - 6:34am

Assessment of abuse liability of Tramadol among experienced drug users: Double-blind crossover randomized controlled trial.

J Opioid Manag. 2016 Nov/Dec;12(6):421-430

Authors: Das M, Jain R, Dhawan A, Kaur A

Abstract
BACKGROUND: Tramadol is a widely used opioid analgesic. Different preclinical, clinical, and postmarketing surveillance studies show conflicting results regarding abuse potential of this drug.
METHODS: A randomized double-blind complete crossover study was conducted at National Drug Dependence Treatment Centre, All India Institute of Medical Sciences, New Delhi. Total subjects were 10, comprising total 120 observations (each subject assessed at baseline, 5, 45, and 240 minutes). Subjects with history of substance abuse were included after detoxification and informed consent. Assessment was done using modified single dose opiate questionnaire, morphine benzedrine group (MBG), pentobarbital chlorpromazine alcohol group (PCAG), and two bipolar visual analogue scales (VAS) after administration of three drugs-Tramadol (100 mg), Buprenorphine (0.6 mg), and Placebo (Normal Saline) intramuscularly, at 5-day interval.
RESULTS: In intra-group analysis, there was statistically significant increase in scores of all four scales from baseline to all three time points after Tramadol and Buprenorphine administration. In inter-group analysis, statistically higher scores were seen for Buprenorphine in comparison to Tramadol at 5, 45, and 240 minutes for MBG scale; the score was significantly higher for Buprenorphine in VAS for pleasurable effect at 45 and 240 minutes, but not at baseline and 5 minutes. There was no significant difference in score at any point of time between Tramadol and Buprenorphine in PCAG scale and VAS for sedative/alertness effect. The scores were statistically insignificant in case of Placebo. All the subjects liked Buprenorphine most and then Tramadol followed by Placebo.
CONCLUSION: Tramadol has abuse potential (even in therapeutic doses) more than Placebo but less than or comparable to Buprenorphine.

PMID: 28059434 [PubMed - in process]

Daclizumab.

January 7, 2017 - 6:34am
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Daclizumab.

Hosp Pharm. 2016 Dec;51(11):928-939

Authors: Kim AP, Baker DE

Abstract
Each month, subscribers to The Formulary Monograph Service receive 5 to 6 well-documented monographs on drugs that are newly released or are in late phase 3 trials. The monographs are targeted to Pharmacy & Therapeutics Committees. Subscribers also receive monthly 1-page summary monographs on agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation/medication use evaluation (DUE/MUE) is also provided each month. With a subscription, the monographs are are available online to subscribers. Monographs can be customized to meet the needs of a facility. Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. For more information about The Formulary Monograph Service, contact Wolters Kluwer customer service at 866-397-3433. The December 2016 monograph topics are ozenoxacin cream, ocrelizumab, naldemedine, eteplirsen, and abaloparatide. The Safety MUE is on buprenorphine buccal.

PMID: 28057953 [PubMed - in process]

A review of a national training initiative to increase provider use of MAT to address the opioid epidemic.

January 5, 2017 - 6:25am

A review of a national training initiative to increase provider use of MAT to address the opioid epidemic.

Am J Addict. 2016 Dec;25(8):603-609

Authors: Levin FR, Bisaga A, Sullivan MA, Williams AR, Cates-Wessel K

Abstract
BACKGROUND AND OBJECTIVES: The Providers' Clinical Support System for Medication Assisted Treatment (PCSS-MAT) initiative focuses on training and mentoring health professionals in the treatment of opioid use disorders (OUD) using pharmacological strategies. Led by the American Academy of Addiction Psychiatry (AAAP), PCSS-MAT is a consortium representing four of the five national professional organizations authorized by DATA 2,000-AAAP, American Osteopathic Academy of Addiction Medicine, American Psychiatric Association, and American Society of Addiction Medicine. DATA organizations are authorized to train physicians to prescribe buprenorphine for OUD treatment. The primary aim of PCSS-MAT is to substantially increase evidence-based practices with medications for OUD.
METHODS: This review describes the development of PCSS-MAT, an ongoing national initiative funded by the Substance Abuse and Mental Health Services Administration (SAMHSA), to address the training needs posed by this critical public health problem. Core initiatives include: (1) Training and mentoring activities for primary care physicians; (2) Outreach to multidisciplinary professional organizations, (3) Creating a resource portal for families, patients, and communities for OUD treatment.
RESULTS: Educational outreach to providers addresses the needs of patients with OUD and common co-occurring psychiatric and medical disorders.
DISCUSSION AND CONCLUSIONS: The overall scope of PCSS-MAT is to increase access to evidence-based treatment of substance use disorders as a public health priority. Recently enacted legislation requires office-based opioid treatment programs to offer all Food and Drug Administration-approved (FDA) forms of MAT.
SCIENTIFIC SIGNIFICANCE: Working with health care providers to effectively deliver MAT is key to integrating behavioral and physical medicine. (Am J Addict 2016;25:603-609).

PMID: 28051841 [PubMed - in process]

Hypothesizing That Neuropharmacological and Neuroimaging Studies of Glutaminergic-Dopaminergic Optimization Complex (KB220Z) Are Associated With &quot;Dopamine Homeostasis&quot; in Reward Deficiency Syndrome (RDS).

December 30, 2016 - 6:58am

Hypothesizing That Neuropharmacological and Neuroimaging Studies of Glutaminergic-Dopaminergic Optimization Complex (KB220Z) Are Associated With "Dopamine Homeostasis" in Reward Deficiency Syndrome (RDS).

Subst Use Misuse. 2016 Dec 29;:1-13

Authors: Blum K, Febo M, Fried L, Li M, Dushaj K, Braverman ER, McLaughlin T, Steinberg B, Badgaiyan RD

Abstract
BACKGROUND: There is need for better treatments of addictive behaviors, both substance and non-substance related, termed Reward Deficiency Syndrome (RDS). While the FDA has approved pharmaceuticals under the umbrella term Medication Assisted Treatment (MAT), these drugs are not optimal.
OBJECTIVES: It is our contention that these drugs work well in the short-term by blocking dopamine function leading to psychological extinction. However, use of buprenorphine/Naloxone over a long period of time results in unwanted addiction liability, reduced emotional affect, and mood changes including suicidal ideation.
METHODS: We are thus proposing a paradigm shift in addiction treatment, with the long-term goal of achieving "Dopamine Homeostasis." While this may be a laudable goal, it is very difficult to achieve. Nevertheless, this commentary briefly reviews past history of developing and subsequently, utilizing a glutaminergic-dopaminergic optimization complex [Kb220Z] shown to be beneficial in at least 20 human clinical trials and in a number of published and unpublished studies.
RESULTS: It is our opinion that, while additional required studies could confirm these findings to date, the cited studies are indicative of achieving enhanced resting state functional connectivity, connectivity volume, and possibly, neuroplasticity. Conclusions/Importance: We are proposing a Reward Deficiency Solution System (RDSS) that includes: Genetic Addiction Risk Score (GARS); Comprehensive Analysis of Reported Drugs (CARD); and a glutaminergic-dopaminergic optimization complex (Kb220Z). Continued investigation of this novel strategy may lead to a better-targeted approach in the long-term, causing dopamine regulation by balancing the glutaminergic-dopaminergic pathways. This may potentially change the landscape of treating all addictions leading us to the promised land.

PMID: 28033474 [PubMed - as supplied by publisher]

Delayed villous maturation in term placentas exposed to opioid maintenance therapy: a retrospective cohort study.

December 28, 2016 - 6:29am
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Delayed villous maturation in term placentas exposed to opioid maintenance therapy: a retrospective cohort study.

Am J Obstet Gynecol. 2016 Dec 23;:

Authors: Serra AE, Lemon LS, Mokhtari NB, Parks WT, Catov JM, Venkataramanan R, Caritis SN

Abstract
BACKGROUND: Opioid use disorder among pregnant women is associated with adverse perinatal outcomes and is increasing in the U.S. The standard of care for pregnant women with OUD is opioid maintenance therapy (OMT) including either methadone or buprenorphine, which can be initiated at any time during pregnancy. These medications are known to cross the placenta but their placental and fetal effects have not been well characterized. Delayed villous maturation, a placental finding associated with stillbirth, was observed in placentas exposed to opioid maintenance therapy. Given the association of delayed villous maturation with stillbirth, and the possible relationship between opioid maintenance therapy and delayed villous maturation, this study was undertaken to explore the association between opioid maintenance therapy and this placental finding. Delayed villous maturation has not previously been reported in placentas exposed to opioids or opioid maintenance therapy.
OBJECTIVES: This study sought to compare risk of delayed villous maturation in term placentas exposed and unexposed to opioid maintenance therapy with buprenorphine or methadone.
STUDY DESIGN: This was a retrospective cohort study conducted between 2010-2012 at Magee-Womens Hospital comparing delayed villous maturation in placentas of women with opioid use disorder exposed to either buprenorphine (n=86) or methadone (n=268) to women without opioid use disorder (n=978). Potential covariates were assessed in univariate analyses with none significantly associated with DVM. The final model used conditional logistic regression adjusting for smoking status alone.
RESULTS: Among women without opioid use disorder (and therefore not exposed to OMT), DVM was identified in 5.7% of placentas while the prevalence among women treated with buprenorphine or methadone was 8.1% and 10.8%. Overall, the crude odds of being diagnosed with DVM were significantly greater in those exposed to opioid maintenance therapy compared to those not exposed (OR 1.86, 95% CI 1.20-2.89). When considered separately, women treated with methadone had significantly greater odds of having a placenta with delayed villous maturation than women without opioid exposure to OMT (OR 2.00, 95% CI 1.52-3.20). Women treated with buprenorphine did not have significantly greater odds of this placental diagnosis when compared to the women unexposed to OMT (OR 1.46, 95% CI 0.64-3.31). Results were similar after accounting for smoking.
CONCLUSIONS: Delayed villous maturation was more common in the placentas of women exposed to opioid maintenance therapy. Further studies are required to characterize rates and extent of DVM in the general population as well as to differentiate between possible effects of opioid exposure (e.g. heroin, illicit use of prescription opioids) vs. those of opioid maintenance therapy (buprenorphine and methadone).

PMID: 28024988 [PubMed - as supplied by publisher]

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