A Human Laboratory Assessment of the Safety and Potential Efficacy of SYN117 (Nepicastat) in Cocaine-dependent Volunteers Receiving Cocaine
Overview
- Phase
- Phase 1
- Intervention
- Cocaine 40mg
- Conditions
- Cocaine Dependence
- Sponsor
- Biotie Therapies Inc.
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- 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.
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This study will assess the potential interaction and subjective effects between intravenous cocaine and SYN117 in non-treatment seeking cocaine dependant subjects
Investigators
Eligibility 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
Arms & Interventions
A
SYN117 placebo and Ascending doses of cocaine (10, 20, 40 mg) and placebo
Intervention: Cocaine 40mg
A
SYN117 placebo and Ascending doses of cocaine (10, 20, 40 mg) and placebo
Intervention: Saline
A
SYN117 placebo and Ascending doses of cocaine (10, 20, 40 mg) and placebo
Intervention: SYN117 Placebo
A
SYN117 placebo and Ascending doses of cocaine (10, 20, 40 mg) and placebo
Intervention: Cocaine 10mg
A
SYN117 placebo and Ascending doses of cocaine (10, 20, 40 mg) and placebo
Intervention: Cocaine 20mg
B
Ascending doses of SYN117 (placebo, 80 mg, 160 mg) and ascending doses of cocaine (10 mg, 20 mg, 40 mg) and placebo
Intervention: SYN117 80 mg
B
Ascending doses of SYN117 (placebo, 80 mg, 160 mg) and ascending doses of cocaine (10 mg, 20 mg, 40 mg) and placebo
Intervention: SYN117 160 mg
B
Ascending doses of SYN117 (placebo, 80 mg, 160 mg) and ascending doses of cocaine (10 mg, 20 mg, 40 mg) and placebo
Intervention: Cocaine 10mg
B
Ascending doses of SYN117 (placebo, 80 mg, 160 mg) and ascending doses of cocaine (10 mg, 20 mg, 40 mg) and placebo
Intervention: Cocaine 20mg
B
Ascending doses of SYN117 (placebo, 80 mg, 160 mg) and ascending doses of cocaine (10 mg, 20 mg, 40 mg) and placebo
Intervention: Cocaine 40mg
B
Ascending doses of SYN117 (placebo, 80 mg, 160 mg) and ascending doses of cocaine (10 mg, 20 mg, 40 mg) and placebo
Intervention: Saline
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Determine tolerability by measuring adverse events(inpatient 14 days, 2 weeks post followup visit)
- Determine subjective effects produced by self administration of cocaine or placebo(Days 4, 8, 12 and 13)
- Determine the effect of SYN117 of the pharmacokinetics of IV cocaine(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(Days 4, 8 and 12)