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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 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.

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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.

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

558 total trials

What the Registry Record Tells You About NCT05886582

The ClinicalTrials.gov registry entry for NCT05886582 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,520-participant average among 58 other Substance-Related Disorders trials with a reported enrollment target (97% lower). The listed sponsor is Virginia Commonwealth University, which has 558 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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

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.