NIDA CTN Big South/West Node Rev13 Yr18 S1 MURB

NIH RePORTER · NIH · UG1 · $2,533,716 · view on reporter.nih.gov ↗

Abstract

ABSTRACT The CTN-0110 MURB study is a 12-week randomized, double-blind, placebo-controlled Phase IIb 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 or opioid misuse not warranting medication for opioid use disorder (MOUD). Participants will complete all study-related tasks over a period of 19 weeks (up to 3 weeks for screening, 12 weeks for the medication phase, and a follow-up safety visit at Week 16).The study intervention is 3 doses of 300mg BUP-Inj (or PBO-Inj) delivered by abdominal subcutaneous injection at Weeks 1, 5 and 9. The primary objective is to evaluate whether assignment to 12 weeks of outpatient BUP-Inj compared to 12 weeks of outpatient PBO-Inj reduces methamphetamine (MA) use as measured by twice-weekly urine drug screens (UDS) during Weeks 9-12. For the primary statistical analysis, generalized estimating equations will be used to model the log-odds of a MA- negative UDS during Weeks 9-12, assuming an autoregressive lag-1 working correlation matrix. The robust (sandwich) estimator will be used to adjust the covariances for the correlation of UDS from the same participant. Missing UDS are imputed as MA-positive.

Key facts

NIH application ID
10695795
Project number
3UG1DA020024-18S1
Recipient
UT SOUTHWESTERN MEDICAL CENTER
Principal Investigator
Steven J Shoptaw
Activity code
UG1
Funding institute
NIH
Fiscal year
2022
Award amount
$2,533,716
Award type
3
Project period
2022-09-02 → 2025-02-28