Extended-Release Naltrexone and Monthly Extended-Release Buprenorphine for Cocaine Use Disorder (CURB-2)

• Status: Not yet recruiting
• Trial end date: 2026-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an 8-week, double-blind, randomized placebo-controlled trial of the efficacy of a combination of extended-release naltrexone (XR-NTX) and extended-release buprenorphine (XR-BUP) compared to matched placebo injections (PBO-Inj) for the treatment of cocaine use disorder (CUD).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Buprenorphine; Naltrexone

Criteria

Inclusion Criteria:

Individuals must meet all of the inclusion criteria in order to be eligible to participate in the study:

1. Be 18 to 65 years of age;

2. Be interested in reducing or stopping cocaine use;

3. Meet DSM-5 criteria for moderate or severe CUD (4 or more criteria);

4. Provide at least 2 urine samples positive for cocaine (out of a possible 3 samples) within a 10-day period collected over a maximum 21 days during screening with at least 2 days between visits;

5. Self-report cocaine use on 18 or more days in the 30-day period prior to consent using the Timeline Follow-Back (TLFB);

6. If female, agree to use acceptable birth control methods and have periodic urine pregnancy testing done during participation in the study unless unable to conceive (e.g., hysterectomy, post-menopause);

7. Provide a urine sample negative for opioids and self-report no opioid use in the past 7 days on the TLFB and Prior and Concomitant Medications (PCM) assessment prior to XR-NTX induction;

8. Be willing to comply with all study procedures and medication instructions.

Exclusion Criteria:

1. Have a psychiatric condition that, in the judgement of the site medical clinician, would make study participation unsafe or which would prevent adherence to study procedures;

Examples include:

• Suicidal or homicidal ideation requiring immediate attention

• Severe inadequately-treated mental health disorder (e.g., active psychosis, uncontrolled bipolar disorder);

2. Have evidence of second- or third-degree heart block, atrial fibrillation, atrial flutter, prolongation of the QTc, or any other finding on the screening electrocardiogram (ECG) that, in the opinion of the site medical clinician, would preclude safe participation in the study;

3. Have a medical condition that, in the judgement of the site medical clinician, would make study participation unsafe or which would make treatment compliance difficult. Medical conditions that may compromise participant safety or study conduct include, but are not limited to, allergy/sensitivity to study medications or diluents and the following results on clinical labs assessed during baseline/screening:

• AST or ALT greater than 5 times the upper limit of normal

• Total bilirubin greater than 2 times the upper limit of normal

• Platelet count <100 x 103/μL

4. Have a body habitus that precludes gluteal intramuscular injection of XR-NTX or abdominal SQ injection of XR-BUP in accordance with the administration equipment (needle) and procedures;

5. Have been in a prior study of pharmacological or behavioral treatment for CUD within 6 months of study consent;

6. Have taken an investigational drug in another study within 30 days of study consent;

7. Have been prescribed and taken naltrexone or buprenorphine within 30 days of study consent;

8. Be currently enrolled in formal treatment studies or addiction treatment services (behavioral or pharmacological);

9. Be at significant clinical risk for development of serotonin syndrome with buprenorphine treatment as determined by the site medical clinician;

10. Have a current pattern of alcohol, benzodiazepine, or other sedative hypnotic use which would preclude safe participation in the study as determined by the site medical clinician;

11. Have a surgery planned or scheduled or otherwise medically require the use of opioid-containing medications (e.g., opioid analgesics) during the study period;

12. Be currently in jail, prison or any inpatient overnight facility as required by court of law or have pending legal action or other situation (e.g., unstable living arrangements) in the judgement of the site investigator that could prevent participation in the study or in any study activities;

13. If female, be currently pregnant, breastfeeding, or planning on conception;

14. Have any condition for which, in the opinion of the site investigator or designee, study participation would not be in their best interest (including but not limited to cognitive impairment, unstable general medical condition, active psychosis) or that could prevent, limit, or confound the protocol-specified assessments.