Study of Safety and Potential Efficacy of SYN117 in Cocaine Dependent Volunteers

A Human Laboratory Assessment of the Safety and Potential Efficacy of SYN117 (Nepicastat) in Cocaine-dependent Volunteers Receiving Cocaine

This study will assess the potential interaction and subjective effects between intravenous cocaine and SYN117 in non-treatment seeking cocaine dependant subjects

Inclusion Criteria:

• non treatment seeking cocaine dependent
• English speaking
• meet DSM IV TR criteria for cocaine dependence
• pulse 50-90bpm
• systolic BP 85-140 mmHg
• diastolic BP 45-90 mmHg
• essentially normal liver and kidney function blood tests
• ECG normal
• sign informed consent
• negative urine pregnancy test at screening and admission

Exclusion Criteria:

• history or evidence of seizure disorder or brain injury
• previous medically adverse reaction to cocaine, including loss of consciousness, chest pain or epileptic seizure
• neurological disorders, organic brain disease, dementia
• psychiatric disorders such as psychosis, schizophrenia, bipolar disorder, major depression
• history of suicide attempts within past 3 months or suicidal ideation/plan
• history of clinically significant heart disease or hypertension
• family history in 1st degree relatives of early cardiovascular morbidity or mortality
• untreated or unstable medical conditions
• positive HIV test
• pregnant or nursing
• have asthma or are currently using alpha, beta agonists or theophylline or other sympathomimetics
• test positive for other drugs of abuse with the exception of cocaine, cocaine metabolites or marijuana
• any other illness, condition or use of psychotropic medications which preclude safe/successful completion of the study
• currently on parole