RECRUITING

Transdermal Rotigotine as Adjunct to Behavioral Therapy for Cocaine Use Disorder

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Phase 2a Double-Blind Placebo-Controlled Trial of Transdermal Rotigotine as Adjunct to Behavioral Therapy for Cocaine Use Disorder

Quick Facts

Study Start:2023-09-11

Study Completion:2026-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05886582

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* Male or female subjects between 18 and 55 years of age. * Meet current DSM-5 criteria for Cocaine Use Disorder (CocUD), moderate or severe * Currently undergoing treatment as usual for CocUD (such as individual or group therapy sessions), or slated for enrollment in a program for CocUD treatment as usual. * 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). * 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.	* 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. * Use of medications contraindicated for concurrent use along with rotigotine. These include dopamine antagonists such as antipsychotic medications (especially neuroleptics) or metoclopramide. * Subjects with evidence or history of any clinically significant medical disorder including biliary obstruction, 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. * 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. * Have metal fragments or other bodily metal (e.g., pacemaker) or significant claustrophobia that would put the subjects at risk for MRI scanning. * Be allergic to rotigotine. * Have taken any investigational drug within 45 days prior to baseline * Show clinically significant symptoms of cocaine or opioid withdrawal * 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

Inclusion Criteria

Exclusion Criteria

* Male or female subjects between 18 and 55 years of age.
* Meet current DSM-5 criteria for Cocaine Use Disorder (CocUD), moderate or severe
* Currently undergoing treatment as usual for CocUD (such as individual or group therapy sessions), or slated for enrollment in a program for CocUD treatment as usual.
* 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).
* 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.

* 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.
* Use of medications contraindicated for concurrent use along with rotigotine. These include dopamine antagonists such as antipsychotic medications (especially neuroleptics) or metoclopramide.
* Subjects with evidence or history of any clinically significant medical disorder including biliary obstruction, 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.
* 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.
* Have metal fragments or other bodily metal (e.g., pacemaker) or significant claustrophobia that would put the subjects at risk for MRI scanning.
* Be allergic to rotigotine.
* Have taken any investigational drug within 45 days prior to baseline
* Show clinically significant symptoms of cocaine or opioid withdrawal
* 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

Contacts and Locations

Study Contact

Kameron Simmons

CONTACT

(804) 827-3784

simmonsk5@vcu.edu

Principal Investigator

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)

Study Locations (Sites)

Virginia Commonwealth University

Richmond, Virginia, 23284

United States

Collaborators and Investigators

Sponsor: Virginia Commonwealth University

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)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-11

Study Completion Date2026-06

Study Record Updates

Study Start Date2023-09-11

Study Completion Date2026-06

Terms related to this study

Additional Relevant MeSH Terms

Substance-Related Disorders