Cariprazine 1.5 MG for Cocaine Use Disorder

University of Pennsylvania, Philadelphia, PA
Cocaine Use Disorder+1 More ConditionsCariprazine 1.5 MG - Drug
18 - 65
All Sexes

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.

Eligible Conditions
  • Cocaine Use Disorder
  • Opioid Use Disorder

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: weeks 6, 7, an 8

weeks 3-8
percentage of cocaine-positive/missing urines across weeks 3-8
the impact of cariprazine (v. placebo) on cocaine use
Week 6
is the percentage of patients who are entirely abstinent from cocaine

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2 Treatment Groups

1 of 2
1 of 2

Experimental Treatment

Non-Treatment Group

48 Total Participants · 2 Treatment Groups

Primary Treatment: Cariprazine 1.5 MG · Has Placebo Group · Phase 2

Experimental Group · 1 Intervention: Cariprazine 1.5 MG · Intervention Types: Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: weeks 6, 7, an 8

Who is running the clinical trial?

Kyle KampmanLead Sponsor
3 Previous Clinical Trials
428 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,305 Previous Clinical Trials
2,022,945 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 1 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have an IQ score of 80 or higher.

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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" - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.