Completed

Cariprazine Impact on Cocaine Use in OUD-CocUD Patients on Buprenorphine-naloxone

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Cariprazine 1.5 MG

+ Placebo

Drug
Who is being recruted

Narcotic-Related Disorders+2

+ Mental Disorders

+ Opioid-Related Disorders

From 18 to 65 Years
+35 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: August 2022
See protocol details

Summary

Principal SponsorKyle Kampman
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 5, 2022

Actual date on which the first participant was enrolled.

This study is a phase 2 trial that aims to explore the effects of a low dose of a medication called Cariprazine (1.5mg/d) on cocaine use in patients who are medically-stable and have Opioid Use Disorder (OUD) with co-occurring Cocaine Use Disorder (CocUD). These patients are already taking a stable dose of Buprenorphine-naloxone (BUP-NX) for at least one week. The study is designed as a relapse-prevention study for patients who have a cocaine-negative urine at the time of study enrollment. The importance of this study lies in its potential to improve treatment for patients dealing with both OUD and CocUD, addressing a significant challenge in current care. Approximately 48 subjects will participate in this single-blind study, where they will be unaware of their medication status. Participants will be randomly assigned to receive either Cariprazine or a placebo in a 2:1 ratio. The study will last for about 11 weeks, including a screening period and a follow-up visit. During this time, subjects will complete various assessments, behavioral tasks, and neurocognition probes monitored by fNIRS. They will take Cariprazine (or placebo) daily for 8 weeks. Urine and blood samples will be collected regularly to monitor compliance and cocaine use. The primary outcome of the study is to measure the impact of Cariprazine (vs. placebo) on cocaine use, as indicated by the percentage of cocaine-positive or missing urine samples across weeks 3-8.

Official TitleA Phase 2a Randomized, Single-blind, Placebo-controlled Pilot Study to Evaluate the Impact of Cariprazine (1.5mg) on Cocaine Use in OUD-CocUD Patients on Buprenorphine-naloxone.
NCT05063201
Principal SponsorKyle Kampman
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

26 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Narcotic-Related DisordersMental DisordersOpioid-Related DisordersSubstance-Related DisordersChemically-Induced Disorders

Criteria

7 inclusion criteria required to participate
An informed consent document understood, voluntarily signed and dated by the subject.
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 provide a urine that is cocaine-negative and buprenorphine-positive on the day of enrollment.
Subject must read at or above eighth grade level, and understand spoken and written English.
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28 exclusion criteria prevent from participating
Current participation (or participation within 30 days prior to the research study) in clinical trial and receipt of investigational drug(s).
Meets DSM-5 criteria for moderate to severe Substance Use Disorder for any substance other than opioids, cocaine, alcohol, marijuana or nicotine as determined by the semi-structured interview. For Alcohol Use Disorder, subjects are excluded if they meet DSM-5 criteria for moderate to severe AUD within the past three months (patients in early or sustained remission are eligible).
Meets current or lifetime DSM-5 criteria for schizophrenia or any psychotic disorder, bipolar I or II disorder, or organic mental disorder, including dementia-related psychosis.
Meets DSM-5 criteria for Major Depressive Disorder AND is currently taking or clinically requires, antidepressant therapy.
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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Group II

Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

University of Pennsylvania

Philadelphia, United StatesOpen University of Pennsylvania in Google Maps
CompletedOne Study Center