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Rotigotine Patch for Cocaine Use Disorder

This study is testing if a skin patch called Rotigotine Transdermal System (Neupro®) can help people with moderate to severe cocaine use disorder. Neupro® is already approved for Parkinson's disease and restless legs syndrome. Participants will receive either the Neupro® patch or a placebo (an inactive patch) along with their usual behavioral therapy. Researchers want to see if Neupro® can reduce cocaine use, which will be measured by urine tests and self-reports after about 5-6 weeks of treatment. They also want to see if it improves brain activity related to self-control. You may be able to join if you are between 25 and 70 years old, meet the criteria for cocaine use disorder, and have a positive cocaine urine test at screening. The current status of this study is unclear.

Study design
This is a randomized, double-blind, placebo-controlled study, meaning participants are randomly assigned to receive either the active patch or a placebo, and neither you nor the researchers will know which you are receiving. It plans to enroll 40 participants.
What's involved
You would wear a Neupro® or placebo patch for about six weeks, starting with a lower dose for the first week and then a target dose for five weeks, followed by a two-day ramp-down. You will also participate in behavioral therapy.
Compensation
Not stated in the trial record.
Follow-up
Cocaine use will be measured at weeks 5-6 of transdermal patch treatment, which is the end of the treatment period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05886582

Transdermal Rotigotine as Adjunct to Behavioral Therapy for Cocaine Use Disorder

Completed
PHASE2Ages 25–70InterventionalTreatment
Virginia Commonwealth University
~50 participants
Updated 2026-08-31 on ClinicalTrials.gov
What's tested:Rotigotine Transdermal System [Neupro]Placebo

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cocaine-positive urine samples
Measured over weeks 5 - 6 of transdermal patch treatment
+1 more outcome measured

Conditions

Substance-Related Disorders

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Cocaine Use Disorder

NCT05886582

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Virginia Commonwealth University

    Richmond, Virginiano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • James M Bjork, PhD · PRINCIPAL_INVESTIGATOR · Virginia Commonwealth University
  • Albert Arias, MD · PRINCIPAL_INVESTIGATOR · Virginia Commonwealth University
  • Tanya Ramey, PHD · STUDY_DIRECTOR · National Institute on Drug Abuse (NIDA)

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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 of the upper limit of normal (if any elevation is above the limit - must be judged by the study physician to be clinically insignificant).
No clinically significant abnormalities on baseline ECG.
Be able to demonstrate an understanding of study procedures and follow instructions including behavioral laboratory and fMRI testing.
Women must either be unable to conceive (i.e., surgically sterilized, sterile, or postmenopausal) or be using a reliable form of contraception (e.g., abstinence, birth control pills, intrauterine device with spermicide, or condoms). Men will be advised to use condoms. All females must provide negative pregnancy urine tests before study entry, at each visit during the study, and the end of study participation.
Body Mass Index (BMI) between 18-45kg/M2 and weight of at least 50kg at screening

Exclusion

Have concurrent secondary DSM-5 diagnosis of any psychoactive substance use disorder other than cocaine, alcohol, methamphetamine, nicotine, opioid, or marijuana use disorder.
Have a DSM-5 axis I psychiatric disorder other than substance use disorder, including but not limited to Bipolar I Disorder, Schizophrenia, or other psychotic disorder that require treatment with antipsychotics, or a neurological disorder requiring ongoing treatment and/or making study participation unsafe. Comorbid PTSD, Generalized Anxiety Disorder and Major Depressive Disorder will be allowed.
Consistent and regular (as opposed to intermittent, infrequent, or as needed) use of medications contraindicated for concurrent use along with RTG, or would confound the mechanism of RTG action and data interpretation. These include DA antagonists such as antipsychotic medications (especially neuroleptics) or metoclopramide.
Subjects with evidence or history of any clinically significant medical disorder including biliary obstruction, clinically significant hepatic disease, severe cardiovascular or pulmonary disease, bronchial asthma, renal, or endocrine disease. However, controlled hypertension, controlled hypothyroidism, and cancer in remission over 5 years will not be excluded.
Have a history of seizures (excluding childhood febrile seizures) or loss of consciousness (e.g. from traumatic brain injury) for more than 30 minutes.
Have significant current suicidal or homicidal ideation or a suicide attempt within the past 6 months, based on the Columbia Suicide Severity Rating Scale (C-SSRS).
Be HIV positive by self-report or history.
Be pregnant or nursing or not using a reliable form of contraception if able to conceive. All females must provide negative pregnancy urine tests before study entry, at each visit during the study, and the end of study participation
Have any other illness, or condition, which in the opinion of the clinical co-investigator (Arias) would preclude safe and/or successful completion of the study.
Be allergic to rotigotine.
Have taken any investigational drug within 45 days prior to baseline
Demonstrate intolerance to, poor adherence to, or extreme skin irritation by daily application of known placebo "practice" skin patches during the screening phase
Current/pending criminal charges that may result in incarceration within the next 60 days
Self-report of allergic or other reactions to sulfites (e.g. in foods)

What this trial measures

  • Cocaine-positive urine samplesweeks 5 - 6 of transdermal patch treatment

    comparison of cocaine-positive urine samples between participants randomized to transdermal RTG relative to participants randomized to placebo patches

  • self-reported cocaine useweeks 5 - 6 of transdermal patch treatment

    comparison of cocaine cocaine use (by self report) between participants randomized to transdermal RTG relative to participants randomized to placebo patches