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RECRUITING Phase 2

Transdermal Rotigotine as Adjunct to Behavioral Therapy for Cocaine Use Disorder

NCT05886582 · View on ClinicalTrials.gov ↗

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.

Interventions

  • DRUG Placebo
  • DRUG Rotigotine Transdermal System [Neupro]

Study Locations (1)

Virginia

  • Virginia Commonwealth University — Richmond

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2023-09-11
Est. Completion 2026-06
Phase Phase 2

Sponsor

Virginia Commonwealth University

513 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05886582

The ClinicalTrials.gov registry entry for NCT05886582 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Virginia Commonwealth University, which has 513 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05886582 reports 1 study location spanning 1 distinct geographic area — top geographies include Virginia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05886582?

The interventions under investigation include: Placebo (DRUG), Rotigotine Transdermal System [Neupro] (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05886582?

This trial is sponsored by Virginia Commonwealth University, which has 513 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial