Transdermal Rotigotine as Adjunct to Behavioral Therapy for Cocaine Use Disorder

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.

Conditions

• Substance-Related Disorders

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

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• Virginia Commonwealth University

  lead OTHER

Principal Investigators

• James M Bjork, PhD · Virginia Commonwealth University

• Albert Arias, MD · Virginia Commonwealth University

• Tanya Ramey, PHD · National Institute on Drug Abuse (NIDA)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

25 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-09-11

Primary Completion

2026-06-30

Completion

2026-06-30

FDA Drug

Yes

Countries

• United States

Study Locations