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

Phase 1

Completed

• Conditions: Cocaine Dependence
• Interventions: Drug: SYN117 80 mg; Drug: SYN117 Placebo; Drug: SYN117 160 mg; Drug: Cocaine 10mg; Drug: Cocaine 20mg; Drug: Cocaine 40mg; Drug: Saline

• Registration Number: NCT00656357
• Lead Sponsor: Biotie Therapies Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-04-04
• Study First Submitted QC: 2008-04-04
• Study First Posted: 2008-04-11
• Study Start: 2008-06
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Disposition First Submitted: 2009-12-03
• Disposition First Submitted QC: 2009-12-03
• Disposition First Posted: 2009-12-07
• Status Verified: 2017-08
• Last Update Submitted: 2018-08-15
• Last Update Posted: 2018-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Cocaine 10mg	Ascending doses of SYN117 (placebo, 80 mg, 160 mg) and ascending doses of cocaine (10 mg, 20 mg, 40 mg) and placebo
A	Cocaine 20mg	SYN117 placebo and Ascending doses of cocaine (10, 20, 40 mg) and placebo
B	Cocaine 20mg	Ascending doses of SYN117 (placebo, 80 mg, 160 mg) and ascending doses of cocaine (10 mg, 20 mg, 40 mg) and placebo
B	Cocaine 40mg	Ascending doses of SYN117 (placebo, 80 mg, 160 mg) and ascending doses of cocaine (10 mg, 20 mg, 40 mg) and placebo
B	SYN117 80 mg	Ascending doses of SYN117 (placebo, 80 mg, 160 mg) and ascending doses of cocaine (10 mg, 20 mg, 40 mg) and placebo
B	SYN117 160 mg	Ascending doses of SYN117 (placebo, 80 mg, 160 mg) and ascending doses of cocaine (10 mg, 20 mg, 40 mg) and placebo
A	Saline	SYN117 placebo and Ascending doses of cocaine (10, 20, 40 mg) and placebo
A	SYN117 Placebo	SYN117 placebo and Ascending doses of cocaine (10, 20, 40 mg) and placebo
A	Cocaine 10mg	SYN117 placebo and Ascending doses of cocaine (10, 20, 40 mg) and placebo
A	Cocaine 40mg	SYN117 placebo and Ascending doses of cocaine (10, 20, 40 mg) and placebo
B	Saline	Ascending doses of SYN117 (placebo, 80 mg, 160 mg) and ascending doses of cocaine (10 mg, 20 mg, 40 mg) and placebo

Primary Outcome Measures

Name	Time	Method
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.	inpatient 14 days with 2 week outpatient follow-up

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Texas Medical Branch (UTMB); 🇺🇸 Galveston, Texas, United States