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

Biotie Therapies

Status and phase: Completed; Phase 2; Phase 1

Conditions: Cocaine Dependence

Treatments: Drug: SYN117 80 mg; Drug: SYN117 Placebo; Drug: Cocaine 20mg; Drug: Cocaine 40mg; Drug: Cocaine 10mg; Drug: Saline; Drug: SYN117 160 mg

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT00656357

SYN117-CL01

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups, including a placebo group

A

Placebo Comparator group

Description:

SYN117 placebo and Ascending doses of cocaine (10, 20, 40 mg) and placebo

Treatment:

Drug: Saline

Drug: Cocaine 10mg

Drug: SYN117 Placebo

Drug: Cocaine 20mg

Drug: Cocaine 40mg

B

Experimental group

Description:

Ascending doses of SYN117 (placebo, 80 mg, 160 mg) and ascending doses of cocaine (10 mg, 20 mg, 40 mg) and placebo

Treatment:

Drug: Saline

Drug: SYN117 160 mg

Drug: Cocaine 10mg

Drug: SYN117 80 mg

Drug: Cocaine 20mg

Drug: Cocaine 40mg