This study will assess the potential interaction and subjective effects between intravenous cocaine and SYN117 in non-treatment seeking cocaine dependant subjects
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
20
University of Texas Medical Branch (UTMB)
Galveston, Texas, United States
Determine the safety of treatment with SYN117 in cocaine-dependent volunteers by measuring hemodynamic and subjective effects of administration of ascending doses of cocaine(10mg, 20mg, 40mg)and placebo during treatment with ascending doses of SYN117.
Time frame: inpatient 14 days with 2 week outpatient follow-up
Determine tolerability by measuring adverse events
Time frame: inpatient 14 days, 2 weeks post followup visit
Determine subjective effects produced by self administration of cocaine or placebo
Time frame: Days 4, 8, 12 and 13
Determine the effect of SYN117 of the pharmacokinetics of IV cocaine
Time frame: Days 3 and 11
Determine if any baseline measures of impulsivity or drug use severity predict efficacy of SYN117 in reducing subjective effects of cocaine
Time frame: Days 4, 8 and 12
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IV Cocaine 10mg
IV Cocaine 20mg
IV Cocaine 40mg
IV Cocaine Placebo