NCT01982643

Accelerated Development of Additive Pharmacotherapy Treatment for Methamphetamine Use Disorder

CTN-0054 Accelerated Development of Additive Pharmacotherapy Treatment (ADAPT) for Methamphetamine Use Disorder

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Walter Ling · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The aim of this 2-stage, 3-site study is to investigate the effectiveness and safety of a combination of extended-release depot naltrexone plus extended-release bupropion as a potential pharmacotherapy for methamphetamine (MA) use disorder.

Detailed description

Stage 1 will include 20 individuals with severe stimulant use disorder (methamphetamine type) enrolled across three study sites. Following a maximum 30-day screening period to establish eligibility, participants will receive a monthly injection of extended-release depot naltrexone (XR-NTX; as Vivitrol®) plus once-daily bupropion extended-release tablets (BRP; as Wellbutrin XL®) for 8 weeks. Take-home oral study medication (BRP) will be dispensed weekly for dosing on non-clinic days. Participants will be asked to attend clinic twice weekly for observed BRP dosing, collection of urine samples, assessments, and medical management. Following the 8-week active medication phase, participants will complete a follow-up phase, including a medication taper and post-medication phase follow-up visit during Week 9. If Stage 1 data document success (see criteria below) in at least 3 "responder" study participants, Stage 2 will follow utilizing the same protocol as in Stage 1, to enroll an additional group of 29 participants. Using the same criteria of "responder" success, if the combined stages document success in at least 9 of 49 study participants, the combination medication will be considered to have shown sufficient potential to advance to a large-scale placebo-controlled trial.

Conditions

• Methamphetamine Use Disorder

Interventions

Type	Name	Description
DRUG	naltrexone plus bupropion	Participants will receive a monthly injection of extended-release depot naltrexone (XR-NTX; as Vivitrol®) plus once-daily bupropion extended-release tablets (BRP; as Wellbutrin XL®) for 8 weeks.

Timeline

• Start date: 2013-11-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2013-11-13
• Last updated: 2020-03-23
• Results posted: 2020-03-23

Locations

3 sites across 1 country: United States