Phase 2a Double-Blind Placebo-Controlled Trial of Transdermal Rotigotine as Adjunct to Behavioral Therapy for Cocaine Use Disorder
Virginia Commonwealth University
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.
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 disord…
Eligibility
- Age range
- 25–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Male or female subjects between 25 and 70 years of age. * Meet current DSM-5 criteria for Cocaine Use Disorder (CocUD), moderate or severe * Able to understand and comply with study procedures * Have positive urine result for cocaine metabolite benzoylecgonine (BE) during at least one screening visit (out of up to three visits, depending on participants' preference) AND/OR self-report of recent cocaine use (approximately past 30 days). * Have hematology and chemistry laboratory tests that are within normal limits, except that liver function tests must be no more than 2x…
Interventions
- DrugRotigotine 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.
- DrugPlacebo
Placebo drug
Location
- Virginia Commonwealth UniversityRichmond, Virginia