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Rotigotine + Behavioral Therapy for Cocaine Use Disorder

Phase 2
Recruiting
Led By James M Bjork, PhD
Research Sponsored by Virginia Commonwealth University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 5 - 6 of transdermal patch treatment
Awards & highlights

Summary

This trial will test if rotigotine can help reduce cocaine use & improve top-down cognitive control in people with cocaine use disorder.

Who is the study for?
Adults aged 18-55 with moderate to severe Cocaine Use Disorder, currently in or starting behavioral therapy for addiction. They must have a positive test for cocaine metabolite and no significant heart issues. Women should be non-pregnant, non-nursing, and using contraception; men advised to use condoms.Check my eligibility
What is being tested?
The trial is testing if the Rotigotine patch (approved for Parkinson's & Restless Legs Syndrome) can reduce cocaine use and improve cognitive control when added to standard behavioral therapy compared to a placebo patch.See study design
What are the potential side effects?
Rotigotine may cause skin irritation at the patch site, sleepiness, headaches, nausea, dizziness or vomiting. It might also lead to unusual body movements or mood changes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 5 - 6 of transdermal patch treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 5 - 6 of transdermal patch treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cocaine-positive urine samples
self-reported cocaine use
Secondary outcome measures
EC from DLPFC to striatum during working memory demands
QoLI total score (change)
dorsolateral prefrontal cortex (DLPFC)
+2 more

Side effects data

From 2018 Phase 4 trial • 40 Patients • NCT03103919
15%
Somnolence
15%
Nausea
5%
Abdominal distension
5%
Abdominal discomfort
5%
Vomiting
5%
Feeling abnormal
5%
Muscular weakness
5%
Headache
5%
Dizziness
5%
Binge eating
5%
Fatigue
5%
Dehydration
5%
Renal impairment
5%
Hallucination, visual
5%
Sleep disorder
5%
Dyspnoea
5%
Constipation
5%
Hallucination, auditory
100%
80%
60%
40%
20%
0%
Study treatment Arm
Rotigotine + Standard Care
Rotigotine + Standard Care + Kinesia-360™ Wearable Device

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active Rotigotine (RTG)Experimental Treatment1 Intervention
Participants who are randomized to the active RTG arm will receive Neupro® RTG patches
Group II: PlaceboPlacebo Group1 Intervention
Participants who are randomized to placebo will receive transdermal patches that match the size and color of active Neupro®.

Find a Location

Who is running the clinical trial?

Virginia Commonwealth UniversityLead Sponsor
702 Previous Clinical Trials
22,886,729 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,503 Previous Clinical Trials
2,625,523 Total Patients Enrolled
James M Bjork, PhDPrincipal InvestigatorVirginia Commonwealth University
1 Previous Clinical Trials
35 Total Patients Enrolled

Media Library

Active Rotigotine (RTG) Clinical Trial Eligibility Overview. Trial Name: NCT05886582 — Phase 2
Substance Use Disorders Research Study Groups: Active Rotigotine (RTG), Placebo
Substance Use Disorders Clinical Trial 2023: Active Rotigotine (RTG) Highlights & Side Effects. Trial Name: NCT05886582 — Phase 2
Active Rotigotine (RTG) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05886582 — Phase 2
~40 spots leftby Jun 2026
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