This study is a 12-week randomized, double-blind, placebo-controlled trial that will investigate the use of injectable buprenorphine (BUP-Inj) compared to injectable placebo (PBO-Inj) for the treatment of methamphetamine use disorder (MUD) among individuals with mild co-use of opioids.
Primary Objective: To evaluate whether assignment to 12 weeks of outpatient BUP-Inj compared to 12 weeks of outpatient PBO-Inj reduces MA use (as measured by twice-weekly urine drug screens (UDS)) during Weeks 9-12 in participants with moderate to severe MUD with co-occurring mild opioid use disorder (OUD) or opioid misuse not warranting medication for opioid use disorder (MOUD). Secondary Objectives: To evaluate whether assignment to 12 weeks of outpatient BUP-Inj compared to 12 weeks of outpatient PBO-Inj among participants with moderate to severe MUD with co-occurring mild OUD or opioid misuse not warranting MOUD improves: 1) outcomes related to alternate measures of MA use including total number of MA negative urine drug screens (UDS) during study and self-reported days of MA use; 2) measures of opioid use and self-reported frequency of opioid use; and 3) measures of MA and opioid co-use and self-reported days of MA and opioid co-use.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
18
Sublingual Buprenorphine induction, then SublocadeTM, Indivior injectable (300mg)
Sublingual buprenorphine induction, then Placebo injectable (300 mg)
UCLA Vine Street Clinic
Los Angeles, California, United States
Highland Hospital, Alameda Health System
Oakland, California, United States
Oklahoma State University, Center for Health Sciences
Tulsa, Oklahoma, United States
CODA
Portland, Oregon, United States
Number of Methamphetamine-negative Urine Samples
Number of Methamphetamine (MA)-negative Urine Drug Screen (UDS) results obtained during Weeks 9 through 12 of the medication phase is measured for the BUP-Inj and PBO-Inj conditions. Number of UDS results / number of expected UDS results. Two UDS results were expected each week.
Time frame: weeks 9-12
Treatment Effective Score (TES) for MA-negative UDS Results
The TES is defined to be the number of MA negative UDS divided by the number of possible UDS collected during the study. In this study there are 24 possible UDS collections so the number of MA negative UDS is divided by 24. Possible score ranges from 0-24; with higher score indicating better outcome.
Time frame: weeks 1-12
Number of Days of Methamphetamine Use During the Medication Phase
Number of days of methamphetamine use during treatment will be measured using Timeline Followback (TLFB) procedure which will be administered to document the participant's self-reported use during Weeks 1-12. Possible scores range from 0-84, with lower scores indicating better outcome.
Time frame: weeks 1-12
Treatment Effective Score (TES) for Opioid Negative UDS Results
The TES is defined to be the number of UDS results negative for opioids divided by the number of possible UDS collected during the study. In this study there are 24 possible UDS collections, so the number of opioid negative UDS is divided by 24. Possible score ranges from 0-24; with higher score indicating better outcome.
Time frame: weeks 1-12
Number of Days of Opioid Use During the Medication Phase
Number of days of opioid use during treatment will be measured using Timeline Followback (TLFB) procedure which will be administered to document the participant's self-reported opioid use at week 12. Possible scores range from 0-84, with lower scores indicating better outcome.
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UTSW Medical Center, Center for Depression Research and Clinical Care
Dallas, Texas, United States
University of Washington Medicine-Harborview Medical Center
Seattle, Washington, United States
Time frame: weeks 1-12
Treatment Effective Score (TES) for MA and Opioid Co-Use Compiled
The TES is defined to be the number of MA and Opioid Co-Use negative UDS divided by the number of possible UDS collected during the study. In this study there are 24 possible UDS collections, so the number of MA and Opioid Co-Use negative UDS is divided by 24. Possible score ranges from 0-24; with higher score indicating better outcome.
Time frame: weeks 1-12
Number of Days of MA and Opioid Co-use During the Medication Phase
Number of days of MA and opioid co-use during treatment will be measured using Timeline Followback (TLFB) procedure which will be administered to document the participant's self-reported use of substances for each day at week 12. Possible scores range from 0-84, with lower scores indicating better outcome.
Time frame: weeks 1-12