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NCT05886582 · ClinicalTrials.gov registry record · Phase 2
Transdermal Rotigotine as Adjunct to Behavioral Therapy for Cocaine Use Disorder
A Phase 2 study of Substance-Related Disorders, sponsored by Virginia Commonwealth University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT05886582: Recruiting Phase 2 study of Substance-Related Disorders, sponsored by Virginia Commonwealth University.
NCT05886582 is a Phase 2 study of Substance-Related Disorders that is actively recruiting participants, run by Virginia Commonwealth University. The registered enrollment target is 40 participants, below the 1,520-participant average among 58 other Substance-Related Disorders trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05886582, a Phase 2 study of Substance-Related Disorders, is actively recruiting participants, sponsored by Virginia Commonwealth University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a randomized, double-blind, placebo-controlled phase 2b pilot clinical trial to determine whether non-ergoline D3/D2/D1 dopamine (DA) receptor agonist rotigotine (RTG), in combination with treatment as usual, including individual or group behavioral therapy can a) reduce cocaine use and also b) increase brain activity in frontocortical areas of the brain, and, as a reflection of that - improve top-down cognitive control in persons with cocaine use disorder (CocUD). Rotigotine is a marketed non-ergoline D3/D2/D1 DA agonist (RTG, Neupro®) in the form of a transdermal patch that is FDA-approved for the treatment of Parkinson's Disease and Restless Legs Syndrome. The premise of this project was based on apparent beneficial effects of RTG in a different human population characterized by executive function (EF) impairment. In light of the deficits in EF common in persons with CocUD, RTG may hold the potential for cognitive improvement in persons with CocUD who are in treatment as usual to both attend to and retain psychoeducation concepts better. In addition, rotigotine may help these individuals in recovery maintain goals better, where goal maintenance is a crucial integrative product of successful EF.
Primary Outcome
comparison of cocaine-positive urine samples between participants randomized to transdermal RTG relative to participants randomized to placebo patches
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Rotigotine Transdermal System [Neupro]
Study Locations (1)
Virginia
- Virginia Commonwealth University - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2023-09-11 |
| Est. Completion | 2026-06 |
| Phase | Phase 2 |
What NCT05886582 shows while recruiting
NCT05886582 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,520-participant average among 58 other Substance-Related Disorders trials with a reported enrollment target (97% lower).
The record links to 1 condition, with Substance-Related Disorders appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05886582 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT05886582 about?
NCT05886582 is a clinical study titled "Transdermal Rotigotine as Adjunct to Behavioral Therapy for Cocaine Use Disorder". This is a randomized, double-blind, placebo-controlled phase 2b pilot clinical trial to determine whether non-ergoline D3/D2/D1 dopamine (DA) receptor agonist rotigotine (RTG), in combination with treatment as usual, including individual or group behavioral therapy can a) reduce cocaine use and also...
What is the current status of trial NCT05886582?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2023-09-11. Estimated completion is 2026-06.
What conditions does trial NCT05886582 study?
This clinical trial studies the following conditions: Substance-Related Disorders.
What interventions are being tested in trial NCT05886582?
The interventions under investigation include: Placebo (DRUG), Rotigotine Transdermal System [Neupro] (DRUG).
Who is sponsoring clinical trial NCT05886582?
This trial is sponsored by Virginia Commonwealth University, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05886582 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Substance-Related Disorders
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05886582's enrollment target sits among peer trials
40 48th of 58 higher than 9 of 58 other Substance-Related Disorders trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Substance-Related Disorders trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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