Cariprazine for Comorbid Cocaine and Opioid Use Disorder

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Kyle Kampman
Study ID
NCT05063201
Phase
PHASE2
Status
Completed

Conditions

  • Cocaine Use Disorder
  • Opioid-use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Cariprazine 1.5 MG — DRUG
    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).
  • Placebo — DRUG
    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 Details

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: 1. Screening (approx. 1-2 weeks) 2. Baseline (1-2 visits; includes baseline assessments, behavioral tasks/fNIRS session, and randomization) 3. 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. 4. Follow-up: A follow-up visit to assess medical and psychological status will occur approximately 1 week after the last dose of study medication.

Key Dates

Start date
Aug 5, 2022
Status verified
Jan 2026
Primary completion
Dec 1, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
26 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cariprazine
  • Placebo Comparator: Placebo

Primary Outcome Measure

percentage of cocaine-positive/missing urines across weeks 3-8 [ Time Frame: weeks 3-8 ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of PennsylvaniaPhiladelphiaPennsylvania19104-

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By research site
University of Pennsylvania· Philadelphia, PA

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