Status:
COMPLETED
Study of Safety and Potential Efficacy of SYN117 in Cocaine Dependent Volunteers
Lead Sponsor:
Biotie Therapies Inc.
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Cocaine Dependence
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
PHASE2
Brief Summary
This study will assess the potential interaction and subjective effects between intravenous cocaine and SYN117 in non-treatment seeking cocaine dependant subjects
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00656357
Start Date
June 1 2008
End Date
May 1 2009
Last Update
August 17 2018
Active Locations (1)
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1
University of Texas Medical Branch (UTMB)
Galveston, Texas, United States, 77555