What is the mechanism of action of this treatment?

The most common treatments for Cocaine Use Disorder (CUD) include medications like Extended-Release Naltrexone (XR-NTX) and Extended-Release Buprenorphine (XR-BUP). Naltrexone works as an opioid receptor antagonist, blocking the euphoric and reinforcing effects of opioids, which helps reduce cravings and prevent relapse. Buprenorphine, a partial opioid agonist, activates opioid receptors to a lesser degree, providing a ceiling effect that minimizes the risk of misuse and dependency. These mechanisms are important for CUD patients as they help manage cravings and reduce the likelihood of relapse, supporting long-term recovery.

What side effects are associated with this type of intervention?

Extended-release naltrexone, an opioid antagonist, can cause side effects such as nausea, headache, dizziness, fatigue, and injection site reactions. It may also lead to liver enzyme abnormalities and, in rare cases, precipitate opioid withdrawal if opioids are used concurrently. Extended-release buprenorphine, a partial opioid agonist, can cause side effects including constipation, headache, nausea, insomnia, and sweating. It may also lead to respiratory depression, particularly if combined with other central nervous system depressants. Both medications require careful monitoring by healthcare providers to manage these potential side effects effectively.

What prior FDA approvals exist?

As of now, there are no FDA-approved medications specifically for the treatment of Cocaine Use Disorder. However, the trial involving extended-release naltrexone (an opioid antagonist) and extended-release buprenorphine (a partial opioid agonist) is exploring their efficacy for CUD. These medications are typically used for opioid use disorder and alcohol use disorder, indicating a potential off-label use for treating CUD.

What other types of research exist?

Promising novel alternatives for treating Cocaine Use Disorder in 2024 include: 1) Modafinil, a wakefulness-promoting agent that has shown potential in reducing cocaine use and cravings. 2) Topiramate, an anticonvulsant that has demonstrated efficacy in reducing cocaine use in clinical trials. 3) Ketamine, which is being explored for its rapid-acting antidepressant effects and potential to reduce cocaine cravings. 4) Varenicline, a partial agonist at nicotinic acetylcholine receptors, which has shown promise in reducing cocaine use. These alternatives are currently under investigation and may offer new avenues for treatment.

← Back to Search

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

Summary

This trial tests a combination of two medications, naltrexone and buprenorphine, for adults addicted to cocaine. Naltrexone blocks the high from cocaine, while buprenorphine helps reduce cravings and withdrawal symptoms. The goal is to see if this combination is more effective. Buprenorphine has been proposed as a treatment for cocaine abuse, and its combination with naltrexone has shown potential in reducing cocaine intake.

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.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 5 up to week 8

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of Cocaine-negative UDS

Secondary study objectives

Mean self reported cocaine craving score

Mean self reported overall functioning

Measures of safety (adverse events)

+1 more

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 Group2 Interventions

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

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Cocaine Use Disorder (CUD) include medications like Extended-Release Naltrexone (XR-NTX) and Extended-Release Buprenorphine (XR-BUP). Naltrexone works as an opioid receptor antagonist, blocking the euphoric and reinforcing effects of opioids, which helps reduce cravings and prevent relapse. Buprenorphine, a partial opioid agonist, activates opioid receptors to a lesser degree, providing a ceiling effect that minimizes the risk of misuse and dependency. These mechanisms are important for CUD patients as they help manage cravings and reduce the likelihood of relapse, supporting long-term recovery.

A systematic review and meta-analysis of medications for stimulant use disorders in patients with co-occurring opioid use disorders.Co-occurring amphetamine use and associated medical and psychiatric comorbidity among opioid-dependent adults: results from the Clinical Trials Network.