Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05063201 · ClinicalTrials.gov registry record · Phase 2
Cariprazine for Comorbid Cocaine and Opioid Use Disorder
A Phase 2 study, sponsored by Kyle Kampman.
- Completed
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
NCT05063201 is a Phase 2 study that has completed, run by Kyle Kampman. The registered enrollment target is 26 participants.
The verdict
NCT05063201, a Phase 2 study, has completed, sponsored by Kyle Kampman.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
Study 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 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 timepo
Interventions
- DRUG Placebo
- DRUG Cariprazine 1.5 MG
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2022-08-05 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05063201
The ClinicalTrials.gov registry entry for NCT05063201 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 26 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kyle Kampman, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05063201 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05063201 about?
NCT05063201 is a clinical study titled "Cariprazine for Comorbid Cocaine and Opioid Use Disorder". 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...
What is the current status of trial NCT05063201?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2022-08-05. Estimated completion is 2025-12-31.
What interventions are being tested in trial NCT05063201?
The interventions under investigation include: Placebo (DRUG), Cariprazine 1.5 MG (DRUG).
Who is sponsoring clinical trial NCT05063201?
This trial is sponsored by Kyle Kampman, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.