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 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.

NCT Number	NCT05886582
Lead Sponsor	Virginia Commonwealth University Collaborators: National Institute on Drug Abuse (NIDA)
Conditions	Substance-Related Disorders
Enrollment	40 participants
Start Date	2023-09-11
Primary Completion	2026-11-30 (estimated)
Study Completion	2026-11-30 (estimated)
Updated on ClinicalTrials.gov	2026-08-10