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
Open accessAbstract
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.
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- Authors
- Mooney, L. J., Hillhouse, M. P., Thomas, C., Ang, A., Sharma, G., Terry, G., Chang, L., Walker, R., Trivedi, M., Croteau, D., Sparenborg, S., & Ling, W.
- Affiliations
- University of Hawaiʻi at Mānoa (US)
- Corresponding author
- Mooney, Larissa J.
- Ang, Alfonso
- ORCID
- Venue
- Journal of Addiction Medicine
- Published
- 2016-07
- Volume
- 10
- Issue
- 4
- Pages
- 236-243
- ISSN
- 1932-0620 (ISSN-L)
- PMC
- PMC4969133
- OpenAlex
- W2460385725
- Cited by
- 25
- References
- 39
- Citations by year
- 2026: 3 · 2025: 4 · 2024: 2 · 2023: 3 · 2022: 1 · 2021: 1 · 2020: 1 · 2019: 3 · 2018: 4 · 2017: 3
- FWCI
- 3.12
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Journal of Addiction Medicine (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- eScholarship (California Digital Library) (submittedVersion)
- Funders
- National Institute on Drug Abuse (U10DA013045, UG1DA020024)
- Topics
- Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Opioid Use Disorder Treatment
- Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Neurotransmitter Receptor Influence on Behavior
- Keywords
- methamphetamine dependence, naltrexone, bupropion, combination pharmacotherapy, treatment safety, treatment efficacy, two-stage design, urine drug testing, opioid antagonists
- MeSH terms
- Adult, Aged, Delayed-Action Preparations, Drug Therapy, Combination, Female, Humans, Male, Methamphetamine, Middle Aged, Naltrexone, Narcotic Antagonists, Pilot Projects, Bupropion, Outcome Assessment, Health Care, Dopamine Uptake Inhibitors, Amphetamine-Related Disorders, Young Adult
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