What side effects are associated with this type of intervention?

Common treatments for Cocaine Use Disorder, particularly those similar to Cariprazine (a partial agonist at dopamine D2 and D3 receptors), can have side effects such as akathisia, insomnia, nausea, and restlessness. Other treatments like naltrexone may cause nausea, headache, dizziness, and fatigue, while disulfiram can lead to drowsiness, headache, and a metallic taste.

What prior FDA approvals exist?

As of now, there are no FDA-approved medications specifically for the treatment of Cocaine Use Disorder. However, research is ongoing to find effective treatments. Cariprazine, a partial agonist at dopamine D2 and D3 receptors, is being studied for its potential in treating this disorder. Similar treatments that target dopamine receptors are being explored, but none have received FDA approval yet.

What other types of research exist?

Promising novel alternatives to Cariprazine for treating Cocaine Use Disorder in 2024 include Prasugrel and Ticagrelor, which have been studied for their potential to reduce vaso-occlusive events and crises in related conditions. Additionally, ongoing research into MDMA-assisted psychotherapy shows potential for treating substance use disorders, including CocUD.

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Antipsychotic

Cariprazine for Cocaine and Opioid Use Disorder

Phase 2

Recruiting

Research Sponsored by Kyle Kampman

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Males and females, aged 18-65 years old, who meet criteria for cocaine use disorder (CocUD) and moderate or severe opioid use disorder (OUD) (based on DSM-5 criteria), have been on a stable dose of BUP-NX for at least one week, and plan to continue taking BUP-NX for at least 12 weeks

Subject must read at or above eighth grade level, and understand spoken and written English

Must not have

Significant renal insufficiency (estimated creatinine clearance less than or equal to 30 ml/min)

Current diagnosis of pain requiring opioids

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 6, 7, an 8

Summary

This trial tests if low-dose cariprazine can help reduce cocaine use in patients who are already being treated for opioid addiction. The medication may help balance brain chemicals that make people feel rewarded when they use drugs, potentially reducing their cravings.

Who is the study for?

Adults aged 18-65 with both cocaine and moderate to severe opioid use disorders, on stable doses of BUP-NX for at least a week, not pregnant or breastfeeding, able to understand English and provide informed consent. Excluded are those with certain mental health conditions, significant medical issues like severe kidney problems or liver damage, current high suicide risk, or taking conflicting medications.

What is being tested?

The study tests if low-dose cariprazine (1.5mg daily) affects cocaine use in patients already on BUP-NX. It's randomized and placebo-controlled; some participants will also undergo brain imaging (fMRI). Over approximately 11 weeks including screening and follow-up phases, urine and blood tests monitor drug compliance.

What are the potential side effects?

While the trial description does not specify side effects of cariprazine at this dose level for these conditions specifically, common side effects may include headache, dizziness, restlessness or feeling jittery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18-65, have CocUD and severe OUD, on stable BUP-NX dose for 1 week, and will continue for 12 weeks.

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I can read and understand English at least at an eighth-grade level.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidneys are not working well (creatinine clearance ≤ 30 ml/min).

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I am currently taking opioids for pain management.

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I have a history of seizures or an uncontrolled seizure disorder.

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I do not take psychoactive drugs, except possibly Benadryl for sleep.

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I have a history of serious liver issues or high liver enzyme levels.

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I do not have severe health issues that would make it unsafe for me to join the study.

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I am taking medication that interacts with BUP-NX.

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I am currently being treated for panic disorder or agoraphobia.

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My anemia is not severe, staying below grade 2.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 6, 7, an 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 6, 7, an 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 6, 7, an 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

percentage of cocaine-positive/missing urines across weeks 3-8

Secondary study objectives

Cocaine

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: CariprazineExperimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

0 / 11Eligibility 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

Common treatments for Cocaine Use Disorder, such as Cariprazine, work by modulating the dopamine system, which is heavily implicated in the rewarding effects of cocaine. Cariprazine acts as a partial agonist at dopamine D2 and D3 receptors, helping to stabilize dopamine levels and reduce cravings and withdrawal symptoms. This mechanism is crucial for patients as it addresses the core neurochemical disruptions caused by cocaine use, potentially reducing the risk of relapse and aiding in long-term recovery.

Randomized clinical trial of disulfiram for cocaine dependence or abuse during buprenorphine treatment.