Rotigotine + Behavioral Therapy for Cocaine Use Disorder

Overseen By Albert Arias, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Virginia Commonwealth University

Must not be taking: Antipsychotics, Metoclopramide

Disqualifiers: Psychoactive disorders, Seizures, HIV, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether rotigotine, a medication for Parkinson's Disease, can help individuals with cocaine use disorder reduce cocaine use and improve brain function. Participants will receive either the rotigotine patch (Rotigotine Transdermal System [Neupro]) or a placebo patch, along with regular behavioral therapy. The trial seeks individuals who have recently used cocaine and can adhere to study procedures. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important early-stage findings.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but you cannot use medications that are not safe to take with rotigotine, like certain antipsychotics or metoclopramide.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that the rotigotine skin patch is generally well-tolerated by patients. Studies have found that most people using the patch for conditions like Parkinson's disease or Restless Legs Syndrome experience mild side effects, if any. Common issues include skin irritation at the application site, nausea, and dizziness. These side effects are usually not serious and often lessen over time.

Since the FDA has already approved rotigotine for other conditions, it has a strong safety record. However, using rotigotine for cocaine use disorder is a new concept. While early research appears promising, the safety and effects for this specific use are still under investigation. Participants in this trial will contribute to understanding how well rotigotine works for treating cocaine use disorder. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for cocaine use disorder?

Researchers are excited about using rotigotine for cocaine use disorder because it offers a novel approach compared to traditional treatments such as behavioral therapies and medications like disulfiram or naltrexone. Unlike these options, rotigotine is a dopamine agonist typically used for Parkinson’s disease, and it works by stimulating dopamine receptors in the brain, which may help reduce cravings and withdrawal symptoms associated with cocaine use. Additionally, rotigotine is administered through a transdermal patch, providing a continuous delivery system that can improve adherence and maintain steady medication levels, potentially enhancing its effectiveness.

What evidence suggests that rotigotine combined with behavioral therapy could be effective for cocaine use disorder?

Research has shown that rotigotine, initially used for Parkinson's Disease and Restless Legs Syndrome, might aid individuals with cocaine use disorder. Studies have found that rotigotine can enhance thinking skills in people with Alzheimer's Disease, suggesting potential benefits for decision-making issues in cocaine users. Another study indicated that rotigotine, combined with behavioral therapy, could reduce cocaine use. Since rotigotine activates dopamine receptors, it may improve self-control, helping patients adhere to their recovery goals. These promising findings have led to further study in this trial, where participants will receive either active rotigotine or a placebo to evaluate its effectiveness in treating cocaine use disorder. ^{1 2 5 6 7}

Who Is on the Research Team?

James M Bjork, PhD

Principal Investigator

Virginia Commonwealth University

Tanya Ramey, PHD

Principal Investigator

National Institute on Drug Abuse (NIDA)

Albert Arias, MD

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Able to understand and comply with study procedures

Women must either be unable to conceive or be using a reliable form of contraception

Have positive urine result for cocaine metabolite benzoylecgonine during at least one screening visit

Exclusion Criteria

Recent use of investigational drugs

Pregnant or nursing or not using a reliable form of contraception if able to conceive

I have had seizures or was unconscious for over 30 minutes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transdermal rotigotine or placebo patches for approximately six weeks to assess reduction in cocaine use and improvement in cognitive performance

6 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Rotigotine Transdermal System [Neupro]

Trial Overview 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.

How Is the Trial Designed?

Group I: Active Rotigotine (RTG) Experimental Treatment 1 Intervention

Participants who are randomized to the active RTG arm will receive Neupro® RTG patches

Group II: Placebo Placebo Group 1 Intervention

Participants who are randomized to placebo will receive transdermal patches that match the size and color of active Neupro®.

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

There are currently no proven effective medications for treating cocaine dependence, but several promising candidates have been identified, including cabergoline, reserpine, sertraline, and tiagabine, which are set for phase II clinical trials.

A novel 'cocaine vaccine' has shown promise in a phase I trial, being well tolerated and producing anti-cocaine antibodies for up to 9 months, indicating a potential new approach to blocking cocaine's effects in the brain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Agents in development for the management of cocaine abuse. Gorelick, DA., Gardner, EL., Xi, ZX.[2018]

Pharmacotherapy for substance abuse is most effective when combined with psychosocial support, and it should be tailored to the patient's current needs as they navigate cycles of use and abstinence.

New long-acting formulations of agonists and antagonists are being developed to improve treatment compliance, while innovative approaches like vaccines and products targeting the dopamine reuptake system are advancing in clinical trials for cocaine abuse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent advances against substance abuse. Heading, CE.[2007]

In a study involving primarily young, indigent African-American crack cocaine users, adjunct therapies like acupuncture, anticraving medication, and brainwave therapy were tested to improve retention in intensive outpatient treatment, but none showed a direct impact on drug use outcomes.

However, higher dosages of any adjunct therapy were linked to increased days in treatment and more standard treatment sessions attended, which correlated with negative drug test results at follow-up, suggesting that while the adjunct therapies didn't directly reduce drug use, they may help keep patients engaged in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of adjunct therapies in crack cocaine treatment. Richard, AJ., Montoya, ID., Nelson, R., et al.[2022]

The new radioiodinated cocaine analog, [123I]IPT, effectively targets striatal dopamine transporters in nonhuman primates, showing rapid concentration in these brain regions within approximately 25 minutes after injection.

The study demonstrated that 95% of the binding of [123I]IPT is reversible and specifically associated with dopamine transporters, making it a valuable tool for in vivo SPECT imaging to study dopamine-related functions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Striatal dopamine transporter imaging in nonhuman primates with iodine-123-IPT SPECT. Malison, RT., Vessotskie, JM., Kung, MP., et al.[2016]

RTI-113, a selective dopamine uptake inhibitor, showed similar behavioral effects to cocaine but was less potent in increasing response rates in squirrel monkeys, indicating it may have a safer profile for potential therapeutic use.

RTI-113 demonstrated a longer duration of action compared to cocaine and effectively reduced cocaine self-administration, suggesting it could be a promising candidate for treating cocaine abuse with fewer stimulant effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative behavioral pharmacology of cocaine and the selective dopamine uptake inhibitor RTI-113 in the squirrel monkey. Howell, LL., Czoty, PW., Kuhar, MJ., et al.[2014]

In a study involving 65 crack-cocaine dependent patients, modafinil did not show significant benefits when added to cognitive behavioral therapy (CBT), as it did not improve treatment retention or reduce cocaine use overall.

However, patients who adhered to modafinil treatment for at least 8 weeks experienced greater reductions in cocaine use, suggesting that optimizing adherence could enhance the effectiveness of modafinil in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modafinil in the treatment of crack-cocaine dependence in the Netherlands: Results of an open-label randomised controlled feasibility trial. Nuijten, M., Blanken, P., van den Brink, W., et al.[2018]

Pharmacological treatments for addiction, such as alpha 2-adrenergic agonists (e.g., clonidine) and naltrexone, target different aspects of the addiction cycle, helping to alleviate withdrawal symptoms and reduce drug reinforcement, respectively.

While these medications can effectively support addiction treatment by addressing specific parts of the cycle, they are not standalone solutions and must be combined with behavioral therapies and patient cooperation for comprehensive care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacological adjuncts in the treatment of opioid and cocaine addicts. Herridge, P., Gold, MS.[2013]

In a 12-week clinical trial involving 94 patients, both amantadine and desipramine showed initial reductions in reported cocaine abuse compared to placebo, but this effect diminished by week 8, indicating limited long-term efficacy.

Despite good treatment retention and compliance, there were no significant differences in cocaine-free urine samples between the medicated groups and placebo, suggesting that these medications may not effectively sustain abstinence in cocaine-abusing methadone-maintained patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacotherapy for cocaine-abusing methadone-maintained patients using amantadine or desipramine. Kosten, TR., Morgan, CM., Falcione, J., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05886582

Transdermal Rotigotine as Adjunct to Behavioral Therapy ... Rotigotine has been shown to improve cognition-related quality of life in persons with Alzheimer's Disease. This is a roughly six week trial of rotigotine ( ...

2. cureswithinreach.org cureswithinreach.org/2024/07/12/daily-rotigotine-patch-to-enhance-behavioral-therapy-for-cocaine-use-disorder-recovery-veterans/

Daily Rotigotine Patch to Enhance Behavioral Therapy for ... Daily Rotigotine Patch to Enhance Behavioral Therapy for Cocaine Use Disorder Recovery in Veterans. Adult, Current Research, Dr. Bjork, Drug ...

3. trialx.com trialx.com/clinical-trials/listings/246426/transdermal-rotigotine-as-adjunct-to-behavioral-therapy-for-cocaine-use-disorder/

Transdermal Rotigotine as Adjunct to Behavioral Therapy ... Rotigotine has been shown to improve cognition-related quality of life in persons with Alzheimer's Disease. This is a roughly six week trial of ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05886582/transdermal-rotigotine-as-adjunct-to-behavioral-therapy-for-cocaine-use-disorder

Transdermal Rotigotine as Adjunct to Behavioral Therapy ... This is a roughly six week trial of rotigotine (given in a skin patch) to determine whether it not only reduces cocaine use in persons in ...

5. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK409667/

RESULTS - Rotigotine (Neupro) (Transdermal Patch) - NCBI Findings from the Literature. A total of four studies were identified from the literature for inclusion in the systematic review (Figure 1).

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/21705273/

Long-term safety and efficacy of rotigotine transdermal ... Primary safety outcomes included occurrence of adverse events and dropouts. Efficacy assessments were secondary and included the International Restless Legs ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2012/021829Orig1s001s002.pdf

Neupro (Rotigotine ) patch transdermal system Present new safety data about deaths from the studies for all proposed indications using the same format as in the original NDA submission. • ...