Buprenorphine/Naloxone and methadone effects on laboratory indices of liver health: a randomized trial.

Background: Buprenorphine/naloxone (BUP) and methadone (MET) are efficacious treatments for opioid dependence, although concerns about a link between BUP and drug-induced hepatitis have been raised. This study compares the effects of BUP and MET on liver health in opioid-dependent participants.

Methods: This was a randomized controlled trial of 1269 opioid-dependent participants seeking treatment at 8 federally licensed opioid treatment programs and followed for up to 32 weeks between May 2006 and August 2010; 731 participants met "evaluable" criteria defined as completing 24 weeks of medication and providing at least 4 blood samples for transaminase testing.

Double-blind placebo-controlled evaluation of the PROMETA™ protocol for methamphetamine dependence.

Aims: To evaluate the efficacy and safety of the PROMETA™ Protocol for treating methamphetamine dependence.

Design: A double-blind, placebo-controlled 108-day study with random assignment to one of two study conditions: active medication with flumazenil (2 mg infusions on days 1, 2, 3, 22, 23), gabapentin (1200 mg to day 40) and hydroxazine (50 mg to day 10) versus placebo medication (with active hydroxazine only).

Setting: Three substance abuse treatment clinics: two in-patient, one out-patient.

Participant characteristics and buprenorphine dose.

Background: Clinical parameters for determining buprenorphine dose have not been adequately examined in treatment outcome research.

Objectives: This study is a secondary analysis of data collected in a recently completed comparison of buprenorphine taper schedules conducted as part of the National Institute on Drug Abuse's Clinical Trials Network to assess whether participant baseline characteristics are associated with buprenorphine dose.

Methods: After 3 weeks of flexible dosing, 516 participants were categorized by dose provided in the final dosing week (9.

Association of race and ethnicity with withdrawal symptoms, attrition, opioid use, and side-effects during buprenorphine therapy.

Some studies report differences in opioid withdrawal between racial/ethnic groups. However, it is not known if these differences are reflected in differential treatment response. Data from National Institute on Drug Abuse (NIDA) Clinical Trials Network-003 were used to examine racial/ethnic differences before and during stabilization with buprenorphine.

Buprenorphine tapering schedule and illicit opioid use.

Aims: To compare the effects of a short or long taper schedule after buprenorphine stabilization on participant outcomes as measured by opioid-free urine tests at the end of each taper period.

Design: This multi-site study sponsored by Clinical Trials Network (CTN, a branch of the US National Institute on Drug Abuse) was conducted from 2003 to 2005 to compare two taper conditions (7 days and 28 days). Data were collected at weekly clinic visits to the end of the taper periods, and at 1-month and 3-month post-taper follow-up visits.