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

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