Transdermal Rotigotine as Adjunct to Behavioral Therapy for Cocaine Use Disorder

Part of paid clinical trials in Richmond, Virginia.

Sponsor
Virginia Commonwealth University
Study ID
NCT05886582
Phase
PHASE2
Status
Recruiting
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Conditions

  • Substance-Related Disorders

Eligibility Criteria

Sex
ALL
Age
25 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Rotigotine Transdermal System [Neupro] — DRUG
    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.
  • Placebo — DRUG
    Placebo drug

Study Details

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.

Key Dates

Start date
Sep 11, 2023
Status verified
Sep 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active Rotigotine (RTG)
    Participants who are randomized to the active RTG arm will receive Neupro® RTG patches
  • Placebo Comparator: Placebo
    Participants who are randomized to placebo will receive transdermal patches that match the size and color of active Neupro®.

Primary Outcome Measure

Cocaine-positive urine samples [ Time Frame: weeks 5 - 6 of transdermal patch treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Virginia Commonwealth UniversityRichmondVirginia23284
Tiffany Pignatello, NP
[email protected]
804-828-3686
Lori Keyser-Marcus, PhD
[email protected]
804-828-3686
James M Bjork, PhD (PRINCIPAL_INVESTIGATOR)
Albert Arias, MD (PRINCIPAL_INVESTIGATOR)

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Virginia Commonwealth University· Richmond, VA

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