Utilizing a two-stage design to investigate the safety and potential efficacy of monthly naltrexone plus once-daily bupropion as a treatment for methamphetamine use disorder

Larissa J. Mooney, Maureen P. Hillhouse, Christie Thomas, Alfonso Ang, Gaurav Sharma, Garth Terry, Linda Chang, Robrina Walker, Madhukar Trivedi, David Croteau, Steven Sparenborg, Walter Ling

Research output: Contribution to journalArticlepeer-review

8 Scopus citations

Abstract

Objectives: This 2-stage open-label pilot study evaluated the safety and potential efficacy of naltrexone + bupropion as a pharmacotherapy for methamphetamine (MA) use disorder. Methods: The study was conducted in 2 stages of recruitment across 3 sites; 20 participants were enrolled in stage 1 and 29 participants were enrolled in stage 2. Eight weeks of open-label pharmacotherapy with a combination of extended-release injectable naltrexone (XR-NTX; Vivitrol) plus extended-release oral bupropion (BRP; Wellbutrin XL) were provided with a smartphone-assisted medication adherence platform. Participants met Diagnostic and Statistical Manual of Mental Disorders, 5th Edition criteria for severe MA use disorder, self-reported ≥20 days of MA use in the 30 days prior to consent, and submitted 3 MA-positive urine drug screens (UDS) out of 4 collected during screening. Participants attended clinic twice weekly for observed BRP dosing, UDS testing, assessments, and medical management; XR-NTX was administered at weeks 1 and 5. A BRP taper and follow-up visit occurred in week 9. Results: Analyses evaluated effects of XR-NTX+BRP to determine the number of "responders" according to a statistically predefined response criterion (6 of 8 MA-negative UDS during the last 4 weeks of medication). The 2-stage design required that stage 1 yield ≥3 responders to continue to stage 2; 11 of the 49 participants met responder criteria across both stages (5 in stage 1, 6 in stage 2). Conclusions: Under the statistical analysis plan, study "success" required ≥9 responders. With 11 responders, the study demonstrated sufficient potential of naltrexone plus bupropion as a combination pharmacotherapy for MA use disorder to warrant further study.

Original languageEnglish (US)
Pages (from-to)236-243
Number of pages8
JournalJournal of addiction medicine
Volume10
Issue number4
DOIs
StatePublished - Aug 1 2016

Keywords

  • Vivitrol
  • bupropion
  • extended-release naltrexone
  • medication treatment
  • methamphetamine dependence
  • pharmacotherapy

ASJC Scopus subject areas

  • Psychiatry and Mental health
  • Pharmacology (medical)

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