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

Tracking Information
First Submitted Date ICMJE	April 4, 2008
First Posted Date ICMJE	April 11, 2008
Last Update Posted Date	January 19, 2018
Actual Study Start Date ICMJE	June 2008
Actual Primary Completion Date	May 2009 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: April 4, 2008)	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 ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00656357 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: April 4, 2008)	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 ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Study of Safety and Potential Efficacy of SYN117 in Cocaine Dependent Volunteers
Official Title ICMJE	A Human Laboratory Assessment of the Safety and Potential Efficacy of SYN117 (Nepicastat) in Cocaine-dependent Volunteers Receiving Cocaine
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 Provided
Study Type ICMJE	Interventional
Study Phase	Phase 1; Phase 2
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	Cocaine Dependence
Intervention ICMJE	Drug: SYN117 Placebo Placebo; Drug: SYN117 80 mg SYN117 80 mg; Drug: SYN117 160 mg SYN117 160 mg; Drug: Cocaine 10mg IV Cocaine 10mg; Drug: Cocaine 20mg IV Cocaine 20mg; Drug: Cocaine 40mg IV Cocaine 40mg; Drug: Saline IV Cocaine Placebo
Study Arms	Placebo Comparator: A SYN117 placebo and Ascending doses of cocaine (10, 20, 40 mg) and placebo Interventions: Drug: SYN117 Placebo Drug: Cocaine 10mg Drug: Cocaine 20mg Drug: Cocaine 40mg Drug: Saline; Experimental: B Ascending doses of SYN117 (placebo, 80 mg, 160 mg) and ascending doses of cocaine (10 mg, 20 mg, 40 mg) and placebo Interventions: Drug: SYN117 80 mg Drug: SYN117 160 mg Drug: Cocaine 10mg Drug: Cocaine 20mg Drug: Cocaine 40mg Drug: Saline
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: July 7, 2009)	20
Original Estimated Enrollment ICMJE; (submitted: April 4, 2008)	16
Actual Study Completion Date	May 2009
Actual Primary Completion Date	May 2009 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 50 Years (Adult)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00656357
Other Study ID Numbers ICMJE	SYN117-CL01
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Biotie Therapies Inc.
Study Sponsor ICMJE	Biotie Therapies Inc.
Collaborators ICMJE	National Institute on Drug Abuse (NIDA)
Investigators ICMJE	Study Chair: Stephen Bandak, MD Biotie Therapies Inc. Study Chair: F. Gerald Moeller, MD UTSW-Houston Principal Investigator: Kathryn Cunningham, PhD UTMB-Galveston
PRS Account	Biotie Therapies Inc.
Verification Date	August 2017
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP