Accelerated Development of Additive Pharmacotherapy Treatment (ADAPT-2) for Methamphetamine Use Disorder

The University of Texas System (UT)

Status and phase: Completed; Phase 3

Conditions: Methamphetamine Use Disorder

Treatments: Drug: Placebo (PLB) Injectable; Drug: Placebo (PLB) Oral; Drug: Naltrexone: Vivitrol®; Drug: Bupropion: Wellbutrin XL®

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT03078075

UG1DA020024 (U.S. NIH Grant/Contract)

CTN-0068

Details and patient eligibility

About

This is a double-blind, placebo-controlled, randomized clinical trial evaluating the efficacy of extended-release naltrexone plus bupropion as a combination pharmacotherapy for methamphetamine use disorder. Participants will be randomly assigned to the active medication combination (AMC) group or matching placebo group and will receive medications over the course of 12 weeks. Follow-ups will occur in weeks 13 and 16.

Full description

There will be 400 adults with moderate or severe methamphetamine use disorder randomized into this multi-site study. Eligibility will be determined during a maximum 21 day screening period. After screening is completed and eligibility is confirmed, including successful administration of a naloxone challenge, participants will begin the 12 week medication phase of the trial. Participants will be randomized to either the 1) AMC arm and receive injections of extended release naltrexone (XR-NTX; as Vivitrol®) plus once-daily oral extended-release bupropion tablets (BUP-XL) or the 2) matching placebo (PLB) arm and receive injections of placebo (iPLB) plus once-daily oral placebo (oPLB) tablets. During the course of the study, participants may be switched to another arm, as determined by the a priori adaptive aspect of the study design. Participants appearing to respond well to their original treatment assignment will not be switched. Overall, approximately 50% of the participants will receive the AMC. Injections will be administered every three weeks, in weeks 1, 4, 7, and 10. Take-home oral study medication (BUP-XL or oPLB) will be dispensed weekly for dosing on non-clinic days. Participants will be asked to attend the clinic twice weekly for observed oral medication dosing, assessments, collection of urine samples, and once-weekly medical management. On non-clinic days, participants will participate in smartphone app-based medication adherence activities. Participants will be asked to complete assessments as indicated on the schedule of assessments. Following the 12 week medication phase, participants will complete a follow-up phase, including a medication taper and post-medication phase follow-up visits during weeks 13 and 16.

Enrollment: 403 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 to 65 years old;
• Interested in reducing/stopping methamphetamine use;
• Speak English;
• Agree to use acceptable birth control (if applicable);
• Be opioid-free at randomization;
• Willing to comply with all study procedures and medication instructions;
• Agree to use a cell phone (or similar study device) to take videos of medication dosing.

Exclusion criteria

• Medical or psychiatric condition which would make participation unsafe;
• Recently participated in a study of pharmacological or behavioral treatment for methamphetamine use disorder;
• Recently taken an investigational drug;
• Prescribed and taken naltrexone or bupropion ≤ 30 days from consent;
• Current or planned extended absence during study period (e.g., jail, surgery, pending legal action);
• Currently pregnant or breastfeeding.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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403 participants in 2 patient groups, including a placebo group

Active Medication Combination (AMC)

Experimental group

Description:

injectable extended release naltrexone plus once daily oral extended-release bupropion tablets

Treatment:

Drug: Bupropion: Wellbutrin XL®

Drug: Naltrexone: Vivitrol®

Matched Placebo (PLB)

Placebo Comparator group

Description:

injectable matching placebo plus once-daily oral placebo tablets

Treatment:

Drug: Placebo (PLB) Oral

Drug: Placebo (PLB) Injectable