Accelerated Development of Additive Pharmacotherapy Treatment (ADAPT-2) for Methamphetamine Use Disorder
Condition: Methamphetamine Use Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed 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.
    

Intervention name(s): Naltrexone: Vivitrol®; Placebo (PLB) Injectable; Bupropion: Wellbutrin XL®; Placebo (PLB) Oral
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Naltrexone: 380 mg vial, 4 intramuscular injections administered every 3 weeks; Placebo: 4 intramuscular injections administered every 3 weeks; Bupropion: 450 mg oral dose daily; Placebo: once-daily oral placebo tablets
Other intervention name(s): Arm: Experimental - Active Medication Combination (AMC); Injectable matching (to Naltrexone) placebo; Arm: Placebo Comparator - matched Placebo (PLB); Arm: Experimental - Active Medication Combination (AMC); Oral matching (to Bupropion) placebo tablets; Arm: Placebo Comparator - matched Placebo (PLB)
Intervention MeSH terms: Naltrexone; Bupropion
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: During the study, participants may or may not be switched to another group due to the adaptive aspect of the study design. Participants appearing to respond well to their original treatment assignment will not be switched.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Methamphetamine; Methamphetamine Use Disorder; Naltrexone; Bupropion; Vivitrol®