NCT05886582

Transdermal Rotigotine as Adjunct to Behavioral Therapy for Cocaine Use Disorder

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 25 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Among different substance use disorders, stimulant use disorders are more consistently linked with impaired executive function (EF) of the brain, which is a set of cognitive skills like working memory that operate to enable self-control over behavior and long-term planning. Medications such as stimulants that increase function of the frontal cortex dopamine (DA) system can improve EF. However, stimulants such as amphetamine have abuse potential. Of interest is determining whether a multiple DA receptor medication like rotigotine could improve brain function in persons with stimulant use disorder who are in therapy, to help them retain educational concepts and strategies better. Rotigotine has been shown to improve cognition-related quality of life in persons with Alzheimer's Disease. This is a roughly six week trial of rotigotine (given in a skin patch) to determine whether it not only reduces cocaine use in persons in treatment for cocaine use disorder, but actually improves cognitive performance itself, and increases activity in the frontal cortex of the brain, compared to placebo. It is hypothesized that rotigotine will be specifically helpful for cognition and abstinence in those participants whose cognitive performance ability tested at baseline is below the median.

Conditions

• Substance-Related Disorders

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-09-11
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2023-06-02
• Last updated: 2025-09-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study