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

Cocaine Dependence Clinical Trial

Official title:

A Human Laboratory Assessment of the Safety and Potential Efficacy of SYN117 (Nepicastat) in Cocaine-dependent Volunteers Receiving Cocaine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00656357
• Other study ID #: SYN117-CL01
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: June 2008
• Est. completion date: May 2009

Study information

• Verified date: August 2017
• Source: Biotie Therapies Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Cocaine Dependence
• Cocaine-Related Disorders

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	University of Texas Medical Branch (UTMB)	Galveston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Biotie Therapies Inc.	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Determine tolerability by measuring adverse events		inpatient 14 days, 2 weeks post followup visit
Secondary	Determine subjective effects produced by self administration of cocaine or placebo		Days 4, 8, 12 and 13
Secondary	Determine the effect of SYN117 of the pharmacokinetics of IV cocaine		Days 3 and 11
Secondary	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