# NIDA Clinical Trials Network: Big South/West Node Supplemental - CURB CTN0109 & KMD CTN0132

> **NIH NIH UG1** · UT SOUTHWESTERN MEDICAL CENTER · 2024 · $4,935,061

## Abstract

Yr20 Supplement Request
Abstract
CTN-0109 Randomized, placebo-controlled trial of extended-release naltrexone and monthly extended-
 release buprenorphine for cocaine use disorder (CURB-2)
This is an 8-week, double-blind, randomized placebo-controlled trial to determine the efficacy of a combination
of extended-release naltrexone (XR-NTX) and extended-release buprenorphine (XR-BUP) compared to
placebo injections (PBO-Inje) for the treatment of cocaine use disorder (CUD). The primary objective is to
evaluate whether assignment of 8 weeks of outpatient XR-NTX + XR-BUP compared to PBO-Inje reduces
urine-verified cocaine use in study Weeks 5 through 8. The primary outcome measure is the proportion of
cocaine-negative urine drug screens (UDS) obtained during Weeks 5 through 8 as measured for the XR-NTX +
XR-BUP and PBO-Inj conditions. The secondary objective is to evaluate the effect of assignment to 8 weeks of
XR-NTX + XR-BUP compared to PBO-Inj on self-report days of cocaine use, cocaine craving, safety, and
treatment effectiveness. The secondary outcome measures are 1) Self-reported days of cocaine use and
cocaine craving effects (Visual Analog Scale (VAS)) during Weeks 0-8; 2) Measures of adverse events during
Weeks 0-8: number and severity of adverse events; number and outcomes (fatal/non-fatal) of overdose events
reported; 3) Measures of Treatment Effectiveness Assessment (TEA) at Week 8.
 Yr20 Supplement Request
Abstract
 CTN-0132 Randomized, Double-Blind, Active Placebo-Controlled Trial of Ketamine for
 Methamphetamine Use Disorder (KMD)
This is a 12-week randomized, double-blind, controlled trial comparing intravenous (IV) ketamine against IV
midazolam delivered over six weeks (acute phase of twice-weekly infusions during Weeks 1, 2, and 3, and one
infusion during Week 4, followed by continuation-phase of one infusion during Week 6; total of eight (8)
infusions over the six-week period) in 120 adults (30 per site) with moderate to severe methamphetamine use
disorder (MUD) (without co-existing opioid use disorder [OUD] of moderate to severe severity).

## Key facts

- **NIH application ID:** 11143552
- **Project number:** 3UG1DA020024-20S1
- **Recipient organization:** UT SOUTHWESTERN MEDICAL CENTER
- **Principal Investigator:** Jennifer Sharpe Potter
- **Activity code:** UG1 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $4,935,061
- **Award type:** 3
- **Project period:** 2024-08-01 → 2025-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11143552

## Citation

> US National Institutes of Health, RePORTER application 11143552, NIDA Clinical Trials Network: Big South/West Node Supplemental - CURB CTN0109 & KMD CTN0132 (3UG1DA020024-20S1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/11143552. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*