Opioid-use DisorderPhase 2NCT05063201
Cariprazine for Comorbid Cocaine and Opioid Use Disorder
A Phase 2 study testing Cariprazine 1.5 MG in people with Opioid-use Disorder and Cocaine Use Disorder, run by Kyle Kampman at 1 site in United States.
Trial summary
This is a phase IIa, randomized, placebo-controlled pilot study designed to examine whether low-dose cariprazine (1.5mg/d) impacts cocaine use in medically-stable OUD patients with co-occurring CocUD who have already been taking BUP-NX at a stable dose for at least one week (up to 24mg buprenorphine/6mg naloxone… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Opioid-use Disorder, Cocaine Use Disorder
- What is being tested?
- Cariprazine 1.5 MG
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2022to 31 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Females must be non-pregnant, non-lactating, and either be of non-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).
- Subject must read at or above eighth grade level, and understand spoken and written English.
- IQ score of ≥ 80.
- Subjects must be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures, and must have access to a cellphone.
Who cannot join
- 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.
- Current comorbid GAD, Social Phobia, Specific Phobia are excluded if in current treatment and/or clinically unstable.
- Current and/or in treatment for Panic Disorder With or Without Agoraphobia, Agoraphobia Without Panic Disorder.
Show all 30Show fewer
- Presence of any another psychiatric and/or medical disorder that in the opinion of the PI will interfere with completion of the study or place the patient at heightened risk through participation in the study.
- Actively suicidal, or present suicidal risk, or who reports a lifetime history of serious or recurrent suicidal behavior, or who has an SBQ-R total score ≥8 at Screening, and/or "yes" answers on items 4 or 5 of the C-SSRS, or in the investigator's clinical judgment present a suicidal risk.
- Currently homicidal to the extent that immediate attention is required.
- Has evidence of a history of significant active hepatitis, significant hepatocellular injury as evidenced by elevated bilirubin levels (>1.3), or, clinically significant levels (over 3x upper limit of normal) of aspartate aminotransferase (AST), or serum alanine aminotransferase (ALT).
- Has positive serology test results at screening for HIV1/HIV2 antibodies, hepatitis B surface antigen, or hepatitis C antibody. If a subject is hepatitis C antibody positive and RNA negative OR their liver function tests are <2 times the upper limit of normal (ULN) range, and they have been treated for hepatitis C, the investigator may include the subject with the approval of the Medical Monitor.
- Anemia more severe than grade 2.
- Significant renal insufficiency (estimated creatinine clearance less than or equal to 30 ml/min).
- Current diagnosis of pain requiring opioids.
- Currently physically dependent on benzodiazepines.
- Significant medical or psychiatric symptoms or dementia which in the opinion of the investigators would preclude compliance with the protocol, adequate cooperation in the study, or obtaining informed consent.
- Concurrent medical conditions (such as severe respiratory insufficiency) that may prevent the patient from safely participating in the study.
- History of seizures (excluding childhood febrile seizure) or uncontrolled seizure disorder.
- Has received medication that could interact adversely with VRAYLAR or BUP-NX within the time of administration of study agent based on the study physician's guidance.
- Needs treatment with any psychoactive medications (with the exception of Benadryl used sparingly, if necessary, for sleep).
- Has demonstrated hypersensitivity or allergy to cariprazine or any ingredients in VRAYLAR capsules or BUP-NX.
- Currently taking a CYP3A4 inhibitor/inducer or agent metabolized through the CYP3A4 pathway likely to interact with BUP-NX to produce clinically significant and/or unfavorable effects.
- Any pending legal action that could prohibit participation and/or compliance in study procedures.
- Living in unstable housing.
- Exclusions for fMRI eligibility:
- An individual who is deemed eligible for participation in the study based upon the criteria listed above, will be excluded from participation in the fMRI session if they meet any of the following criteria:
- History of serious head trauma or injury causing loss of consciousness that lasted more than 3 minutes and/or associated with skull fracture or intracranial bleeding or abnormal MRI.
- Presence of magnetically active prosthetics, plates, pins, broken needles, permanent retainer, bullets, etc. in patient's body (unless a radiologist confirms that its presence is unproblematic). An x-ray may be obtained to determine eligibility.
- Claustrophobia or other medical condition that disables the participant from lying in the MRI for approximately 60 minutes.
- Non-removable skin patches, at discretion of PI.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A 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.
This is a phase IIa, randomized, placebo-controlled pilot study designed to examine whether low-dose cariprazine (1.5mg/d) impacts cocaine use in medically-stable OUD patients with co-occurring CocUD who have already been taking BUP-NX at a stable dose for at least one week (up to 24mg buprenorphine/6mg naloxone daily). To be eligible for this relapse-prevention study, patients will have a cocaine-negative urine at the time of study enrollment.
Approximately 48 subjects will be randomized to participate in this study. At randomization, patients will be stratified on cocaine-use severity, e.g., < 8 days cocaine use in the prior month (less severe) vs. > 8 days cocaine use in the prior month (more severe). A subset (n=24) of participants who are fMRI-eligible will also participate in an fMRI session during the trial, examining whether cariprazine impacts the brain response to relapse-relevant probes of reward and inhibition. All fMRI-eligible patients will be offered the scanning opportunity, until 24 scans are acquired.
Read more
Blinding: This pilot study will be designated as single-blind. Participants are blind to their medication status. In our single-blind studies, we also ask our clinical / patient-interacting staff to remain "blind" to the participants' medication status (similar to 'double-blind' studies), but our non-treatment (e.g., engineering) staff have access to participant group status for preliminary data examinations.
After enrollment, subjects will be randomized to receive 1.5mg/d cariprazine or placebo in a 2:1 ratio. At baseline, subjects will complete several assessments, behavioral tasks and neurocognition probes monitored by fNIRS and will then begin taking cariprazine (or placebo) each day for 8 weeks. The behavioral tasks and fNIRS session will be collected again 10-17 days after taking the first dose of study medication, when plasma levels of cariprazine are likely approaching steady-state; fMRI probes will be collected at the steady-state timepoint in the fMRI-eligible subgroup. Urines will be collected 2x/weekly throughout the trial; weekly blood samples will be analyzed for buprenorphine/norbuprenorphine as an index of BUP-NX compliance, and for metabolites of cariprazine, for cariprazine compliance. Individuals will participate for approximately 11 weeks, inclusive of the screening period and follow-up visit; maximal study medication exposure for each subject is up to 8 weeks.
The study has 4 distinct phases:
- Screening (approx. 1-2 weeks)
- Baseline (1-2 visits; includes baseline assessments, behavioral tasks/fNIRS session, and randomization)
- Outpatient treatment (8 wks; 2 visits/wk, includes daily cariprazine (or placebo), daily BUP-NX (at the participants' usual community treatment site), and imaging (fMRI and fNIRS)/behavioral tasks at steady-state.
- Follow-up: A follow-up visit to assess medical and psychological status will occur approximately 1 week after the last dose of study medication.
- Conditions
- Opioid-use Disorder, Cocaine Use Disorder
- Being tested
- Cariprazine 1.5 MG, Placebo
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cariprazine 1.5 MGDrug
Subjects will attend two visits per week during the 8-week Outpatient Treatment Phase. Counseling services, in the form of Medication Management (MM) will be provided weekly. A urine sample for drug testing, vitals, AEs, and COWS will be collected/assessed at each visit. At the first weekly visit attended, concomitant medications, medication compliance, AIMS and a blood sample for later analysis of plasma levels of cariprazine and its metabolites will also be collected. The TLFB, C-SSRS, CSSA, SOWS, BSCS, DTS and a UPT (females only) will be collected once weekly. On the final appointment of week 8 only, a physical exam and ECG will be performed and standard laboratory measures (blood chemistry, CBC with differential, fasting glucose and lipids, serum prolactin, medical urinalysis) will be assessed. During week 8, additional assessments will be collected, including the ASI, HAM A/D and Treatment Opinion Form (TOF).
PlaceboDrug
Subjects will attend two visits per week during the 8-week Outpatient Treatment Phase. Counseling services, in the form of Medication Management (MM) will be provided weekly. A urine sample for drug testing, vitals, AEs, and COWS will be collected/assessed at each visit. At the first weekly visit attended, concomitant medications, medication compliance, AIMS and a blood sample for later analysis of plasma levels of cariprazine and its metabolites will also be collected. The TLFB, C-SSRS, CSSA, SOWS, BSCS, DTS and a UPT (females only) will be collected once weekly. On the final appointment of week 8 only, a physical exam and ECG will be performed and standard laboratory measures (blood chemistry, CBC with differential, fasting glucose and lipids, serum prolactin, medical urinalysis) will be assessed. During week 8, additional assessments will be collected, including the ASI, HAM A/D and Treatment Opinion Form (TOF).
| Study group | Role | What they receive |
|---|---|---|
| Cariprazine | Experimental | Not described Receives: Drug: Cariprazine 1.5 MG |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of cocaine-positive/missing urines across weeks 3-8
The primary clinical outcome measure is the impact of cariprazine (v. placebo) on cocaine use (percentage of cocaine-positive/missing urines across weeks 3-8). Cocaine-positive urines will be assessed by urines positive for benzoylecognine (BE), a metabolite of cocaine.
Measured: weeks 3-8
Secondary outcomes (1)
percentage of patients who are entirely abstinent from cocaine
The secondary clinical outcome measure is the percentage of patients who are entirely abstinent from cocaine in the final 3 weeks of the trial (weeks 6, 7, and 8).
Measured: weeks 6, 7, an 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start5 Aug 2022
- Primary completion1 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyle Kampman
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, Kyle Kampman, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05063201
- Sponsor's protocol ID
- 849150
- Status last verified
- Jan 2026
- First submitted
- 21 Sep 2021
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 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.
- ClinicalTrials.gov ID
- NCT05063201
- Acronym / sponsor ID
- 849150
- Conditions
- Opioid-use Disorder, Cocaine Use Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Kyle KampmanUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 5 Aug 2022 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 1 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase IIa, randomized, placebo-controlled pilot study designed to examine whether low-dose cariprazine (1.5mg/d) impacts cocaine use in medically-stable OUD patients with co-occurring CocUD who have already been taking BUP-NX at a stable dose for at least one week (up to 24mg buprenorphine/6mg naloxone daily). To be eligible for this relapse-prevention study, patients will have a cocaine-negative urine at the time of study enrollment.
Approximately 48 subjects will be randomized to participate in this study. At randomization, patients will be stratified on cocaine-use severity, e.g., < 8 days cocaine use in the prior month (less severe) vs. > 8 days cocaine use in the prior month (more severe). A subset (n=24) of participants who are fMRI-eligible will also participate in an fMRI session during the trial, examining whether cariprazine impacts the brain response to relapse-relevant probes of reward and inhibition. All fMRI-eligible patients will be offered the scanning opportunity, until 24 scans are acquired.
Blinding: This pilot study will be designated as single-blind. Participants are blind to their medication status. In our single-blind studies, we also ask our clinical / patient-interacting staff to remain "blind" to the participants' medication status (similar to 'double-blind' studies), but our non-treatment (e.g., engineering) staff have access to participant group status for preliminary data examinations.
After enrollment, subjects will be randomized to receive 1.5mg/d cariprazine or placebo in a 2:1 ratio. At baseline, subjects will complete several assessments, behavioral tasks and neurocognition probes monitored by fNIRS and will then begin taking cariprazine (or placebo) each day for 8 weeks. The behavioral tasks and fNIRS session will be collected again 10-17 days after taking the first dose of study medication, when plasma levels of cariprazine are likely approaching steady-state; fMRI probes will be collected at the steady-state timepoint in the fMRI-eligible subgroup. Urines will be collected 2x/weekly throughout the trial; weekly blood samples will be analyzed for buprenorphine/norbuprenorphine as an index of BUP-NX compliance, and for metabolites of cariprazine, for cariprazine compliance. Individuals will participate for approximately 11 weeks, inclusive of the screening period and follow-up visit; maximal study medication exposure for each subject is up to 8 weeks.
The study has 4 distinct phases:
- Screening (approx. 1-2 weeks)
- Baseline (1-2 visits; includes baseline assessments, behavioral tasks/fNIRS session, and randomization)
- Outpatient treatment (8 wks; 2 visits/wk, includes daily cariprazine (or placebo), daily BUP-NX (at the participants' usual community treatment site), and imaging (fMRI and fNIRS)/behavioral tasks at steady-state.
- Follow-up: A follow-up visit to assess medical and psychological status will occur approximately 1 week after the last dose of study medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cariprazine | Experimental | Drug: Cariprazine 1.5 MG |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- Females must be non-pregnant, non-lactating, and either be of non-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).
- Subject must read at or above eighth grade level, and understand spoken and written English.
Key exclusion criteria (30 listed)
- 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.
- Current comorbid GAD, Social Phobia, Specific Phobia are excluded if in current treatment and/or clinically unstable.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cariprazine 1.5 MGSubjects will attend two visits per week during the 8-week Outpatient Treatment Phase. Counseling services, in the form of Medication Management (MM) will be provided weekly. A urine sample for drug testing, vitals, AEs, and COWS will be collected/assessed at each visit. At the first weekly visit attended, concomitant medications, medication compliance, AIMS and a blood sample for later analysis of plasma levels of cariprazine and its metabolites will also be collected. The TLFB, C-SSRS, CSSA, SOWS, BSCS, DTS and a UPT (females only) will be collected once weekly. On the final appointment of week 8 only, a physical exam and ECG will be performed and standard laboratory measures (blood chemistry, CBC with differential, fasting glucose and lipids, serum prolactin, medical urinalysis) will be assessed. During week 8, additional assessments will be collected, including the ASI, HAM A/D and Treatment Opinion Form (TOF). | Drug | Cariprazine |
| PlaceboSubjects will attend two visits per week during the 8-week Outpatient Treatment Phase. Counseling services, in the form of Medication Management (MM) will be provided weekly. A urine sample for drug testing, vitals, AEs, and COWS will be collected/assessed at each visit. At the first weekly visit attended, concomitant medications, medication compliance, AIMS and a blood sample for later analysis of plasma levels of cariprazine and its metabolites will also be collected. The TLFB, C-SSRS, CSSA, SOWS, BSCS, DTS and a UPT (females only) will be collected once weekly. On the final appointment of week 8 only, a physical exam and ECG will be performed and standard laboratory measures (blood chemistry, CBC with differential, fasting glucose and lipids, serum prolactin, medical urinalysis) will be assessed. During week 8, additional assessments will be collected, including the ASI, HAM A/D and Treatment Opinion Form (TOF). | Drug | Placebo |
Primary outcome
percentage of cocaine-positive/missing urines across weeks 3-8
Time frame: weeks 3-8
The primary clinical outcome measure is the impact of cariprazine (v. placebo) on cocaine use (percentage of cocaine-positive/missing urines across weeks 3-8). Cocaine-positive urines will be assessed by urines positive for benzoylecognine (BE), a metabolite of cocaine.
1 secondary outcome
percentage of patients who are entirely abstinent from cocaine
Time frame: weeks 6, 7, an 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cariprazine 1.5 MG in people with Opioid-use Disorder and Cocaine Use Disorder, run by Kyle Kampman at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of cocaine-positive/missing urines across weeks 3-8 (time frame: weeks 3-8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.