Using a skin patch to help treat cocaine use disorder

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

This study is testing if a skin patch with a medication can help people with cocaine use disorder reduce their drug use and improve their thinking skills while they receive therapy.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 25 Years to 70 Years
• Sex: All
• Sponsor: Virginia Commonwealth University (Academic / other)
• Locations: 1 site (Richmond, Virginia)
• Trial ID: NCT05886582 on ClinicalTrials.gov

What this trial studies

This phase 2b pilot clinical trial investigates the effects of rotigotine, a dopamine receptor agonist, when used alongside standard behavioral therapy for individuals with cocaine use disorder. The study is randomized, double-blind, and placebo-controlled, aiming to assess whether rotigotine can reduce cocaine use and enhance cognitive function by increasing brain activity in the frontal cortex. Participants will receive either the rotigotine patch or a placebo over a six-week period while undergoing treatment for their disorder. The trial focuses on individuals with impaired executive function, hypothesizing that rotigotine may improve both cognitive performance and abstinence rates.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 55 who meet the DSM-5 criteria for moderate or severe cocaine use disorder and are currently undergoing treatment.

Not a fit: Patients with mild cocaine use disorder or those not currently in treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve cognitive function and reduce cocaine use in patients with cocaine use disorder.

How similar studies have performed: While the use of rotigotine for cocaine use disorder is novel, similar approaches have shown promise in improving cognitive function in other populations.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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)

Where this trial is running

Richmond, Virginia

• Virginia Commonwealth University — Richmond, Virginia, United States (Recruiting)

Study contacts

• Principal investigator: James M Bjork, PhD — Virginia Commonwealth University
• Study coordinator: Tiffany Pignatello, FNP

Conditions Substance-Related Disorders