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Naltrexone + Bupropion for Methamphetamine Addiction

Phase 3

Recruiting

Led By Shwe Gyaw, MD

Research Sponsored by National Institute on Drug Abuse (NIDA)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Agrees to use a smartphone app (downloaded for free to own device or on a study provided smartphone device) to take daily videos of medication dosing.

Provides at least 2 urine samples positive for MA out of up to 3 tests, which will occur at least 2 days apart within a 10-day period;

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 weeks (i. e., weeks 11-12)

Awards & highlights

Pivotal Trial

Summary

This trial aims to see if a new medication, extended release naltrexone plus bupropion XL, is more effective than a placebo in helping people with moderate or severe methamphetamine use disorder

Who is the study for?

This trial is for adults aged 18-65 with moderate to severe methamphetamine use disorder who want to reduce or stop using. Participants must have tested positive for methamphetamine twice, be willing to follow study procedures and medication instructions, and use a smartphone app for daily video dosing. Women of childbearing potential must agree to birth control measures.

What is being tested?

The trial tests if extended-release naltrexone combined with bupropion XL (XR-NTX/BUP-XL) is more effective than placebo in reducing methamphetamine use among individuals seeking treatment. It compares the drug combination against matched injectable and oral placebos.

What are the potential side effects?

Possible side effects include nausea, headache, constipation, insomnia, dizziness from naltrexone; dry mouth, sweating, agitation from bupropion. Both drugs may cause other reactions depending on individual health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I agree to use a smartphone app for daily medication videos.

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I have provided at least 2 positive urine tests for methamphetamine.

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I am between 18 and 65 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 weeks (i. e., weeks 11-12)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 weeks (i. e., weeks 11-12)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks (i. e., weeks 11-12) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants with at least 75% methamphetamine-negative urine drug screen tests during the evaluation period (i. e., Weeks 11-12)

Secondary study objectives

Quality of Life as measured by PROMIS® Profile 29 for adults

Severity of Craving as measured by Visual Analog Scale

Severity of Depression as assessed by the Patient Health Questionnaire-9

+2 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: XR-NTX/BUP-XLExperimental Treatment2 Interventions

Participants randomized to the (XR-NTX/BUP-XL) arm will receive 450 mg of once-daily oral extended-release bupropion tablets and once every three weeks (Weeks 1, 4, 7, and 10) injections of extended-release naltrexone (Vivitrol®)

Group II: PLB/PLBPlacebo Group2 Interventions

Participants randomized to the PLB arm will receive once-daily placebo tablets and once every three weeks (Weeks 1, 4, 7, and 10) placebo injections.

0 / 3Eligibility criteria met