Transdermal Rotigotine as Adjunct to Behavioral Therapy for Cocaine Use Disorder

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 atleast 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, exceptthat liver function tests must be no more than 2x of the upper limit of normal (ifany elevation is above the limit - must be judged by the study physician to beclinically insignificant).

• No clinically significant abnormalities on baseline ECG.

• Be able to demonstrate an understanding of study procedures and follow instructionsincluding behavioral laboratory and fMRI testing.

• Women must either be unable to conceive (i.e., surgically sterilized, sterile, orpostmenopausal) or be using a reliable form of contraception (e.g., abstinence,birth control pills, intrauterine device with spermicide, or condoms). Men will beadvised to use condoms. All females must provide negative pregnancy urine testsbefore study entry, at each visit during the study, and the end of studyparticipation.

• 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 disorderother than cocaine, alcohol, methamphetamine, nicotine, opioid, or marijuana usedisorder.

• Have a DSM-5 axis I psychiatric disorder other than substance use disorder,including but not limited to Bipolar I Disorder, Schizophrenia, or other psychoticdisorder that require treatment with antipsychotics, or a neurological disorderrequiring 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 ofmedications contraindicated for concurrent use along with RTG, or would confound themechanism of RTG action and data interpretation. These include DA antagonists suchas antipsychotic medications (especially neuroleptics) or metoclopramide.

• Subjects with evidence or history of any clinically significant medical disorderincluding biliary obstruction, clinically significant hepatic disease, severecardiovascular or pulmonary disease, bronchial asthma, renal, or endocrine disease.However, controlled hypertension, controlled hypothyroidism, and cancer in remissionover 5 years will not be excluded.

• Have a history of seizures (excluding childhood febrile seizures) or loss ofconsciousness (e.g. from traumatic brain injury) for more than 30 minutes.

• Have significant current suicidal or homicidal ideation or a suicide attempt withinthe 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 toconceive. All females must provide negative pregnancy urine tests before studyentry, at each visit during the study, and the end of study participation

• Have any other illness, or condition, which in the opinion of the clinicalco-investigator (Arias) would preclude safe and/or successful completion of thestudy.

• 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 dailyapplication of known placebo "practice" skin patches during the screening phase

• Current/pending criminal charges that may result in incarceration within the next 60days

• Self-report of allergic or other reactions to sulfites (e.g. in foods)