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

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Biotie Therapies Inc.
ClinicalTrials.gov Identifier:
NCT00656357
First received: April 4, 2008
Last updated: March 9, 2016
Last verified: February 2014
History of Changes

April 4, 2008
March 9, 2016
June 2008
May 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00656357 on ClinicalTrials.gov Archive Site
  • Determine tolerability by measuring adverse events [ Time Frame: inpatient 14 days, 2 weeks post followup visit ] [ Designated as safety issue: No ]
  • Determine subjective effects produced by self administration of cocaine or placebo [ Time Frame: Days 4, 8, 12 and 13 ] [ Designated as safety issue: No ]
  • Determine the effect of SYN117 of the pharmacokinetics of IV cocaine [ Time Frame: Days 3 and 11 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of Safety and Potential Efficacy of SYN117 in Cocaine Dependent Volunteers
A Human Laboratory Assessment of the Safety and Potential Efficacy of SYN117 (Nepicastat) in Cocaine-dependent Volunteers Receiving Cocaine
This study will assess the potential interaction and subjective effects between intravenous cocaine and SYN117 in non-treatment seeking cocaine dependant subjects
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Cocaine Dependence
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
Not Provided
May 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 50 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00656357
SYN117-CL01
Yes
Not Provided
Not Provided
Biotie Therapies Inc.
Biotie Therapies Inc.
National Institute on Drug Abuse (NIDA)
Study Chair: Stephen Bandak, MD Biotie Therapies Inc.
Study Chair: F. Gerald Moeller, MD UTSW-Houston
Principal Investigator: Kathryn Cunningham, PhD UTMB-Galveston
Biotie Therapies Inc.
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP