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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 6, 7, an 8
Awards & highlights

Study Summary

This trial is testing whether the drug cariprazine, given at a low dose, can help people with medical stable opioid addiction who are also addicted to cocaine, and who have already been taking BUP-NX for at least a week. The trial will last for 11 weeks and will include 48 subjects.

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.Check my eligibility
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.See study design
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
Select...
I am 18-65, have CocUD and severe OUD, on stable BUP-NX dose for 1 week, and will continue for 12 weeks.
Select...
I can read and understand English at least at an eighth-grade level.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
percentage of cocaine-positive/missing urines across weeks 3-8
Secondary outcome measures
Cocaine

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: CariprazineExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Kyle KampmanLead Sponsor
3 Previous Clinical Trials
428 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,464 Previous Clinical Trials
2,618,545 Total Patients Enrolled

Media Library

Cariprazine (Antipsychotic) Clinical Trial Eligibility Overview. Trial Name: NCT05063201 — Phase 2
Cocaine Use Disorder Research Study Groups: Cariprazine, Placebo
Cocaine Use Disorder Clinical Trial 2023: Cariprazine Highlights & Side Effects. Trial Name: NCT05063201 — Phase 2
Cariprazine (Antipsychotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05063201 — Phase 2

Frequently Asked Questions

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

Are elderly individuals being sought out for this particular research study?

"Patients must be between 18-65 years old to participate, as specified in the eligibility requirements."

Answered by AI

What are the potential dangers of Cariprazine 1.5 MG?

"While there is some data supporting Cariprazine 1.5 MG's safety, it did not receive a higher score because there is no evidence of efficacy in human trials yet."

Answered by AI

Are participants still being sought for this clinical trial?

"The study, which was originally advertised on August 5th, is looking for enrollees. The listing was most recently updated on August 8th."

Answered by AI

Could you direct me to where I could find more information on Cariprazine 1.5 MG?

"Currently, 8 studies are active and researching Cariprazine 1.5 MG. Out of these 8 trials, 5 are in Phase 3 with the remaining in earlier stages. Additionally, there are 189 unique clinical trial locations for Cariprazine 1.5 MG across Bogotá, Texas, and other parts of the world."

Answered by AI

What other similar trials have been conducted in the past?

"Allergan sponsored the first clinical trial for Cariprazine 1.5 MG in 2019, which only involved 330 patients. Since then, there have been 8 more active trials spread out over 12 countries and 58 cities. Phase 3 drug approval was given to Cariprazine 1.5 MG after the first successful trial."

Answered by AI

Are there any prerequisites to qualify for this research program?

"This clinical trial is looking for 48 patients that have cocaine use disorders and are between 18-65 years old. The most important criteria for candidates are as follows: Subjects must be willing to cooperate with scheduled visits, treatment plan, laboratory tests, and other study procedures, have access to a cellphone., Females must not pregnant, lactating, or of childbearing potential (e.g., sterilized via hysterectomy or bilateral tubal ligation or at least 1 year post-menopausal) or of childbearing potential but practicing a highly-effective contraception method (failure rate <1%, guided by CDC reference list"

Answered by AI

Who else is applying?

What site did they apply to?
University of Pennsylvania
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

Interested in taking a study and make money.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Cariprazine for Comorbid Cocaine and Opioid Use Disorder
Kyle Kampman 2022. "Cariprazine for Comorbid Cocaine and Opioid Use Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05063201.
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~18 spots leftby Apr 2025
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