Study of Safety and Potential Efficacy of SYN117 in Cocaine Dependent Volunteers
NCT ID: NCT00656357
Last Updated: 2018-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
20 participants
INTERVENTIONAL
2008-06-30
2009-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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A
SYN117 placebo and Ascending doses of cocaine (10, 20, 40 mg) and placebo
SYN117 Placebo
Placebo
Cocaine 10mg
IV Cocaine 10mg
Cocaine 20mg
IV Cocaine 20mg
Cocaine 40mg
IV Cocaine 40mg
Saline
IV Cocaine Placebo
B
Ascending doses of SYN117 (placebo, 80 mg, 160 mg) and ascending doses of cocaine (10 mg, 20 mg, 40 mg) and placebo
SYN117 80 mg
SYN117 80 mg
SYN117 160 mg
SYN117 160 mg
Cocaine 10mg
IV Cocaine 10mg
Cocaine 20mg
IV Cocaine 20mg
Cocaine 40mg
IV Cocaine 40mg
Saline
IV Cocaine Placebo
Interventions
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SYN117 Placebo
Placebo
SYN117 80 mg
SYN117 80 mg
SYN117 160 mg
SYN117 160 mg
Cocaine 10mg
IV Cocaine 10mg
Cocaine 20mg
IV Cocaine 20mg
Cocaine 40mg
IV Cocaine 40mg
Saline
IV Cocaine Placebo
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
50 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Biotie Therapies Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Stephen Bandak, MD
Role: STUDY_CHAIR
Biotie Therapies Inc.
F. Gerald Moeller, MD
Role: STUDY_CHAIR
UTSW-Houston
Kathryn Cunningham, PhD
Role: PRINCIPAL_INVESTIGATOR
UTMB-Galveston
Locations
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University of Texas Medical Branch (UTMB)
Galveston, Texas, United States
Countries
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Other Identifiers
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SYN117-CL01
Identifier Type: -
Identifier Source: org_study_id
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