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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.

Journal of Addiction Medicine 2016;10(4):236-243. [doi: 10.1097/ADM.0000000000000218]

Larissa J. Mooney, PhD (University of California, Los Angeles, PR Node), Maureen P. Hillhouse, PhD (University of California, Los Angeles, PR Node), Christie Thomas, MPH (University of California, Los Angeles, PR Node), Alfonso Ang, PhD (University of California, Los Angeles, PR Node), Gaurav Sharma, PhD (CTN Data & Statistics Center, Emmes Corporation), Garth Terry, MD, PhD (University of California, Los Angeles, PR Node), Linda Chang, MD (University of Hawaii, PR Node), N. Robrina Walker, PhD (University of Texas Southwestern Medical Center, TX Node), Madhukar H. Trivedi, MD (University of Texas Southwestern Medical Center, TX Node), David Croteau, MD (CTN Data & Statistics Center, Emmes Corporation), Steven Sparenborg, PhD (Center for the Clinical Trials Network, NIDA), Walter Ling, MD (University of California, Los Angeles, PR Node).

This is the Primary Outcomes Article for CTN-0054. This 2-stage open-label pilot study evaluated the safety and potential efficacy of naltrexone + bupropion as a pharmacotherapy for methamphetamine (MA) use disorder. 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 or more 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.

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 or more 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: The primary objective of this single-arm, open-label pilot study was to evaluate the safety and preliminary efficacy of XR-NTX + BRP as a potential treatment for MA use disorder. Under the statistical analysis plan, study "success" required 9 or more 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. Findings also support the general safety and tolerability of this medication combination in MA users, and had high rates of retention and medication adherence. (Article (Peer-Reviewed), PDF, English, 2016)

Keywords: Bupropion | CTN primary outcomes | Methamphetamine | Naltrexone | Pharmacological therapy | Stimulant abuse | Journal of Addiction Medicine (journal)

Document No: 1201, PMID: 27379819, PMCID: PMC4969133.

Submitted by CTN Dissemination Librarians, 7/6/2016.

Ang, Alfonso
Chang, Linda
Croteau, David
Hillhouse, Maureen P.
Ling, Walter
Mooney, Larissa J. search
Sharma, Gaurav mail
Sparenborg, Steven mail
Terry, Garth search
Thomas, Christie
Trivedi, Madhukar H. mail
Walker, N. Robrina mail
NIDA-CTN-0054 www
Pacific Region (Lead) www
Texas www

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