Actively Recruiting
Transdermal Rotigotine as Adjunct to Behavioral Therapy for Cocaine Use Disorder
Led by Virginia Commonwealth University · Updated on 2025-09-29
40
Participants Needed
1
Research Sites
142 weeks
Total Duration
On this page
Sponsors
V
Virginia Commonwealth University
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Transdermal Rotigotine as Adjunct to Behavioral Therapy for Cocaine Use Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 and/or self-report recent cocaine use (past 30 days).
- Hematology and chemistry tests within normal limits, liver function tests no more than 2 times upper limit of normal or clinically insignificant if elevated.
- No clinically significant abnormalities on baseline ECG.
- Able to understand study procedures and follow instructions including behavioral laboratory and fMRI testing.
- Women must be unable to conceive or use reliable contraception; men advised to use condoms.
- All females must provide negative pregnancy urine tests before entry, at each visit, and at study end.
- Body Mass Index (BMI) between 18-45 kg/m2 and weight at least 50 kg at screening.
You will not qualify if you...
- Concurrent secondary DSM-5 diagnosis of psychoactive substance use disorder other than cocaine, alcohol, methamphetamine, nicotine, opioid, or marijuana use disorder.
- DSM-5 axis I psychiatric disorder other than substance use disorder requiring antipsychotic treatment, or neurological disorder requiring ongoing treatment or unsafe for participation; comorbid PTSD, Generalized Anxiety Disorder, and Major Depressive Disorder allowed.
- Regular use of medications contraindicated with rotigotine or confounding its action (e.g., dopamine antagonists like antipsychotics or metoclopramide).
- Clinically significant medical disorders including biliary obstruction, severe hepatic disease, severe cardiovascular or pulmonary disease, bronchial asthma, renal or endocrine disease; controlled hypertension, hypothyroidism, and cancer in remission over 5 years allowed.
- History of seizures (excluding childhood febrile seizures) or loss of consciousness over 30 minutes.
- Significant current suicidal or homicidal ideation or suicide attempt within past 6 months.
- HIV positive by self-report or history.
- Pregnant, nursing, or not using reliable contraception if able to conceive.
- Any illness or condition judged by investigator to preclude safe or successful study completion.
- Allergy to rotigotine.
- Use of any investigational drug within 45 days prior to baseline.
- Intolerance, poor adherence, or extreme skin irritation with placebo practice patches during screening.
- Current or pending criminal charges that may lead to incarceration within 60 days.
- Self-reported allergy or reaction to sulfites (e.g., in foods).
AI-Screening
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Trial Site Locations
Total: 1 location
1
Virginia Commonwealth University
Richmond, Virginia, United States, 23284
Actively Recruiting
Research Team
T
Tiffany Pignatello, FNP
CONTACT
L
Lori Keyser-Marcus, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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