Phase 2, Double-Blind, Placebo-Controlled Trial of Bupropion for Methamphetamine Dependence

National Institute on Drug Abuse (NIDA)200 enrolled

Overview

This study is to assess the efficacy of bupropion in reducing methamphetamine use in subjects with methamphetamine dependence who report using methamphetamine 29 or less days during the 30 days prior to the start of signing consent.

The primary objective of this study is to assess the efficacy of bupropion in reducing methamphetamine use in subjects with methamphetamine dependence who report using methamphetamine 29 or less days during the 30 days prior to signing consent. Secondary objectives included but were not limited to: assessing the success or failure to achieve abstinence (confirmed by at least two methamphetaminenegative urines and no methamphetamine-positive urines) each week during the last two weeks (Weeks 11 and 12) for subjects using methamphetamine 18 or less days during the 30 days prior to signing consent, assessing the safety of bupropion in this study population, assessing other measures of efficacy of bupropion in reducing methamphetamine use or craving, and other psychological assessments of methamphetamine dependence. It is hypothesized that bupropion, compared to placebo, would be associated with an increase in the proportion of subjects who achieved abstinence (confirmed by at least two methamphetamine-negative urines and no methamphetaminepositive urines) each week during the last two weeks (Weeks 11 and 12) for non-daily users.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

200

Conditions

Methamphetamine Dependence

Interventions

BupropionDRUG

150mg for the first 3 days of dosing. Increased to 150 mg b.i.d until taper.

PlaceboOTHER

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Must have a DSM-IV diagnosis of methamphetamine dependence as determined by MINI * Must have at least 1 amphetamine or methamphetamine positive urine specimen after the start of screening and before randomization or provide information to verify recent use if a positive urine sample can't be obtained * Must report using methamphetamine for 29 days or less during the 30 day period prior signing consent using the timeline follow-back method * Must be willing and able to comply with study procedures * Must be able to verbalize and understand consent forms and provide written informed consent * Must be seeking treatment for methamphetamine dependence Exclusion Criteria: * Please contact study site for more information

Locations (12)

UCLA Integrated Substance Abuse Program

Los Angeles, California, United States

South Bay Treatment Center

San Diego, California, United States

Addiction and Pharmacology Research Laboratory

San Francisco, California, United States

Outcomes

Primary Outcomes

Number of Subjects Showing Abstinence

The primary efficacy outcome measure was a measurement of treatment success or failure, where a subject who successfully achieved two weeks of abstinence during the last two weeks of investigational product dosing (Weeks 11 and 12) was scored as a success.

Time frame: Weeks 11 and 12

Secondary Outcomes

Treatment Success Among Subjects With 18 or Less Days of Methamphetamine Use

The study population for this outcome measure is defined as those participants with methamphetamine dependence who report using methamphetamine 18 or less days during the 30 days prior to signing consent.

Time frame: 30 days

Data from ClinicalTrials.gov

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