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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

Study 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 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 5 - 6 of transdermal patch treatment

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

Abdominal distension

Abdominal discomfort

Vomiting

Feeling abnormal

Muscular weakness

Headache

Dizziness

Binge eating

Fatigue

Dehydration

Renal impairment

Hallucination, visual

Sleep disorder

Dyspnoea

Constipation

Hallucination, auditory

100%

80%

60%

40%

20%

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®.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Virginia Commonwealth UniversityLead Sponsor

699 Previous Clinical Trials

22,884,985 Total Patients Enrolled

National Institute on Drug Abuse (NIDA)NIH

2,470 Previous Clinical Trials

2,619,671 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this trial accept participants aged 80 or older?

"Adolescents that are above the age of consent and youth aged 55 or younger may participate in this research."

Answered by AI

Is there any possibility for me to take part in this endeavor?

"Potential participants must demonstrate symptoms of substance abuse and be within the age range between 18 to 55 years old. This clinical trial has vacancies for approximately 60 individuals."

Answered by AI

Has the Active Rotigotine (RTG) drug received authorization from the FDA?

"Following the assessment of our team at Power, Active Rotigotine (RTG) was given a rating of 2. This is due to its Phase 2 status; while there are safety data present, efficacy has not yet been proven."

Answered by AI

Is this investigation actively searching for participants?

"This particular trial, which had its initial posting on June 1st 2023 and was last updated the same day, is no longer seeking patients. However, there are 365 other medical trials actively enrolling subjects at this present moment."

Answered by AI

What is the aim of this trial's research?

"Over the course of weeks 5 and 6, patient self-reported cocaine use will be analyzed as the primary metric for success. Secondary measures that may hint at a successful outcome include changes in CNS-VS Neurocognition Index (NCI) scores, recruitment of dorsolateral prefrontal cortex (DLPFC), and right anterior insula activation during Stop Signal Task testing (SST)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Transdermal Rotigotine as Adjunct to Behavioral Therapy for Cocaine Use Disorder

2023. "Transdermal Rotigotine as Adjunct to Behavioral Therapy for Cocaine Use Disorder". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05886582.

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