Relapse Prevention in Stimulant Use Disorder

Summary

The purpose of this study is to assess the relationship between bupropion, stimulant use and relapse, ADHD (Attention Deficit Hyperactivity Disorder), and measures of mood, drug craving, and inhibitory control in individuals enrolled in inpatient treatment for stimulant-use disorder with and without ADHD.

The experimenters hypothesize that Bupropion and Contrave (Bupropion/Naltrexone) will increase inhibitory control and decrease drug craving and depressive symptoms in recently abstinent stimulant users in inpatient treatment with effects greater than those seen in recently abstinent stimulant users completing inpatient treatment as usual. An additional hypothesis is that relapse rates after leaving inpatient treatment in the group receiving bupropion will be lower than those of the group completing inpatient treatment as usual.

The study design consists of four assessments of drug craving, inhibitory control, impulsive choice, and mood (depression and anxiety). The timepoints for these assessments include: A. baseline after entering treatment B. 2 weeks after starting drug C. 8 weeks after starting drug, and D. 1 month after leaving treatment. Following eligibility screening, 60 stimulant users will be enrolled in one of 3 groups. Group 1 Bupropion Active Group: 20 subjects will receive bupropion for 8 weeks during inpatient treatment. Group 2 Contrave Active Group: 20 subjects will receive Contrave for 8 weeks during inpatient treatment. Group 3 Control Group: 20 subjects enrolled in inpatient treatment will complete treatment as usual as well as the four assessments (A-D) described above but will not receive drug (convenience control). Half of the subjects in each group will be diagnosed with ADHD and half will not, for a total of 10 subjects per group with ADHD.

Conditions

• Stimulant Use
• Relapse
• Cognitive Function
• ADHD

Interventions

DRUG

Contrave 8Mg-90Mg Extended-Release Tablet

Naltrexone HCl/Bupropion HCl is an FDA-approved weight-loss medication with efficacy via the mesolimbic dopamine system to reduce hunger and help control cravings.

DRUG

Bupropion

Bupropion is FDA-approved and marketed both as an antidepressant agent (Wellbutrin®) and treatment for smoking cessation (Zyban®) and has shown efficacy in reducing symptoms of depression and drug craving in stimulant users. it is also a promising candidate to improve cognition function.

Sponsors & Collaborators

• University of California, Los Angeles

  lead OTHER

Principal Investigators

• Edythe D London, Ph.D. · University of California, Los Angeles

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-06-11

Primary Completion

2025-01-11

Completion

2025-01-11

FDA Drug

Yes

Countries

• United States

Study Locations