# NIDA CTN Big South/West Node Rev13 Yr18 S1 MURB

> **NIH NIH UG1** · UT SOUTHWESTERN MEDICAL CENTER · 2022 · $2,533,716

## 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 organization:** UT SOUTHWESTERN MEDICAL CENTER
- **Principal Investigator:** Steven J Shoptaw
- **Activity code:** UG1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $2,533,716
- **Award type:** 3
- **Project period:** 2022-09-02 → 2025-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10695795

## Citation

> US National Institutes of Health, RePORTER application 10695795, NIDA CTN Big South/West Node Rev13 Yr18 S1 MURB (3UG1DA020024-18S1). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/10695795. Licensed CC0.

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