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

• Status: Completed
• Trial end date: 2009-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biotie Therapies Inc.
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Cocaine

Criteria

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