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

Condition Intervention Phase
Cocaine Dependence
Drug: SYN117 Placebo
Drug: SYN117 80 mg
Drug: SYN117 160 mg
Drug: Cocaine 10mg
Drug: Cocaine 20mg
Drug: Cocaine 40mg
Drug: Saline
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Human Laboratory Assessment of the Safety and Potential Efficacy of SYN117 (Nepicastat) in Cocaine-dependent Volunteers Receiving Cocaine

Resource links provided by NLM:


Further study details as provided by Biotie Therapies Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 20
Study Start Date: June 2008
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: A
SYN117 placebo and Ascending doses of cocaine (10, 20, 40 mg) and placebo
Drug: SYN117 Placebo
Placebo
Drug: Cocaine 10mg
IV Cocaine 10mg
Drug: Cocaine 20mg
IV Cocaine 20mg
Drug: Cocaine 40mg
IV Cocaine 40mg
Drug: Saline
IV Cocaine Placebo
Experimental: B
Ascending doses of SYN117 (placebo, 80 mg, 160 mg) and ascending doses of cocaine (10 mg, 20 mg, 40 mg) and 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

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00656357

Locations
United States, Texas
University of Texas Medical Branch (UTMB)
Galveston, Texas, United States, 77555
Sponsors and Collaborators
Biotie Therapies Inc.
National Institute on Drug Abuse (NIDA)
Investigators
Study Chair: Stephen Bandak, MD Biotie Therapies Inc.
Study Chair: F. Gerald Moeller, MD UTSW-Houston
Principal Investigator: Kathryn Cunningham, PhD UTMB-Galveston
  More Information

Responsible Party: Biotie Therapies Inc.
ClinicalTrials.gov Identifier: NCT00656357     History of Changes
Other Study ID Numbers: SYN117-CL01 
Study First Received: April 4, 2008
Last Updated: March 9, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Cocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on August 24, 2016