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Partial Opioid Agonist

Extended-Release Naltrexone + Buprenorphine for Cocaine Use Disorder (CURB-2 Trial)

Phase 2
Recruiting
Led By Madhukar Trivedi, MD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be 18 to 65 years of age
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 5 up to week 8
Awards & highlights

CURB-2 Trial Summary

This trial tests if XR-NTX & XR-BUP could reduce cocaine use in people with CUD, compared to a placebo.

Who is the study for?
Adults aged 18-65 with moderate to severe Cocaine Use Disorder, who want to reduce or stop cocaine use. They must have used cocaine frequently in the past month and not be using opioids. Women should agree to birth control measures. People with certain psychiatric conditions, heart issues, liver problems, blood disorders, or those at risk for serotonin syndrome are excluded.Check my eligibility
What is being tested?
The trial is testing if a combination of extended-release naltrexone (XR-NTX) and extended-release buprenorphine (XR-BUP) is more effective than placebo injections in treating Cocaine Use Disorder over an 8-week period. Participants will be randomly assigned to receive either the medication combo or placebo.See study design
What are the potential side effects?
Possible side effects include nausea, headache, dizziness, fatigue, injection site reactions like pain or swelling; mood changes such as anxiety or depression; sleep disturbances; appetite changes; and potential opioid withdrawal symptoms.

CURB-2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 65 years old.

CURB-2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 5 up to week 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 5 up to week 8 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of Cocaine-negative UDS
Secondary outcome measures
Mean self reported cocaine craving score
Mean self reported overall functioning
Measures of safety (adverse events)
+1 more

CURB-2 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Drug intervention (XR-NTX+XR-BUP)Experimental Treatment2 Interventions
The study intervention is three doses of 380mg XR-NTX (Weeks 0, 3 and 6) and two doses of 300mg XR-BUP (Weeks 0, 4). Drug: XR-NTX XR-NTX: 3 intramuscular injections administered Week 0, 3, 6. Other Names: Extended Release Injectable Naltrexone Arm: Experimental Drug: XR-BUP XR-BUP: 2 subcutaneous injections administered Week 0, 4. Other Names: Extended Release Injectable Buprenorphine Arm: Experimental
Group II: PlaceboPlacebo Group1 Intervention
Matched placebo injections (PBO-Inj) for the treatment of cocaine use disorder (CUD). Drug: Placebo (PLB) Injectable Placebo: 3 intramuscular injections administered Week 0, 3, 6. Other Names: Injectable matching (to XR-NTX) placebo Arm: Placebo Comparator - matched Placebo (PLB) Drug: Placebo (PLB) Injectable Placebo: 2 subcutaneous injections administered Week 0, 4. Other Names: Injectable matching (to XR-BUP) placebo Arm: Placebo Comparator - matched Placebo (PLB)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Extended-Release Naltrexone
2014
Completed Phase 4
~990

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,047 Previous Clinical Trials
1,053,373 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,468 Previous Clinical Trials
2,618,922 Total Patients Enrolled
Madhukar Trivedi, MDPrincipal InvestigatorUT Southwestern Medical Center
14 Previous Clinical Trials
10,650 Total Patients Enrolled

Media Library

Extended Release Buprenorphine (Partial Opioid Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05262270 — Phase 2
Cocaine Use Disorder Research Study Groups: Drug intervention (XR-NTX+XR-BUP), Placebo
Cocaine Use Disorder Clinical Trial 2023: Extended Release Buprenorphine Highlights & Side Effects. Trial Name: NCT05262270 — Phase 2
Extended Release Buprenorphine (Partial Opioid Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05262270 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this medical experiment have an upper age limit?

"This medical trial is only for adults aged between 18 and 65; minors have 260 studies available to them, whereas seniors can choose from 653 research programs."

Answered by AI

Has the combination of XR-NTX and XR-BUP been ratified by the FDA?

"Our team has rated the safety of Drug Intervention (XR-NTX+ XR-BUP) to be a 2, as this is only at Phase 2. That means that while there have been some studies into its security, none yet support efficacy."

Answered by AI

How extensive is the participant enrollment for this scientific investigation?

"Indeed, the information on clinicaltrials.gov reveal that this study is accepting participants. This research endeavor was first posted on March 14th 2023 and last updated on May 2nd 2023; it seeks to recruit 426 patients from two distinct locations."

Answered by AI

Are there currently openings in this clinical investigation for participants?

"Affirmative. The details available on clinicaltrials.gov demonstrate that this medical investigation is currently enrolling applicants, with the protocol first uploaded on March 14th 2023 and most recently modified on May 2nd 2023. A total of 426 individuals need to be recruited between two distinct locations."

Answered by AI

Am I eligible to enroll in this research endeavor?

"This medical trial requires 426 participants with cocaine use disorder who meet the following conditions: aging between 18 and 65 years, expressing an interest in decreasing or discontinuing their consumption of cocaine, adhering to DSM-5 criteria for moderate/severe CUD (4+ symptoms), providing two urine samples that test positive for cocaine within a 10 day window over 21 days during screening, detailing their past 30-day usage on the Timeline Follow-Back questionnaire, contracepting if female unless incapable of conceiving naturally (e.g., hysterectomy or postmenopause), delivering a sample devoid of opioids as well as declaring no"

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Center on Substance Use and Health (CSUH)
Other
UCLA Vine Street Clinic
UTSW Medical Center, Center for Depression Research and Clinical Care
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I want to stop smoking. Cocaine. Trying to find other options and won’t I h to stay clean.
PatientReceived 1 prior treatment
I have been secretly using cociaine l for years now, and it is currently effecting my living situation. As well as social and finances. I am willing try anything that will help with this and give hope to others and help them.
PatientReceived 1 prior treatment
I’m at a desperate point in my life and want/need to quit. I’m self employed and my business, personal and financial problems are starting to be an issue. Never thought this was going to happen to me but here I am. I had one long jaunt of sobriety 9 years but have struggled with cocaine addiction for over 20 years. I’ve tried so many things to get clean again and have failed every time. I need help. I have grandchildren I want to live for and children who have addiction and alcohol problems. I’m so lost. Looking outside the normal AA and rehab solution. Been there it worked but can’t seem to get back in it and work it like before. The drug has control of me so badly. Please help me.
PatientReceived 1 prior treatment
~194 spots leftby Mar 2025