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RECRUITING
NCT05886582
PHASE2

Transdermal Rotigotine as Adjunct to Behavioral Therapy for Cocaine Use Disorder

Sponsor: Virginia Commonwealth University

View on ClinicalTrials.gov

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.

Official title: Phase 2a Double-Blind Placebo-Controlled Trial of Transdermal Rotigotine as Adjunct to Behavioral Therapy for Cocaine Use Disorder

Key Details

Gender

All

Age Range

25 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2023-09-11

Completion Date

2026-06

Last Updated

2025-09-29

Healthy Volunteers

No

Interventions

DRUG

Rotigotine Transdermal System [Neupro]

Neupro® 2mg/24h transdermal patches for the first seven days, followed by the target 4mg dose for the subsequent 35 days (five weeks) of dosing up to the follow-up assessments, followed by two days of 2mg/24h ramp-down dose.

DRUG

Placebo

Placebo drug

Locations (1)

Virginia Commonwealth University

Richmond, Virginia, United States