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

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ClinicalTrials.gov Identifier: NCT00656357
Recruitment Status : Completed
First Posted : April 11, 2008
Last Update Posted : January 19, 2018
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Biotie Therapies Inc.

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

Condition or disease Intervention/treatment 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  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Actual Study Start Date : June 2008
Primary Completion Date : May 2009
Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: A
SYN117 placebo and Ascending doses of cocaine (10, 20, 40 mg) and placebo
Drug: SYN117 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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Determine tolerability by measuring adverse events [ Time Frame: inpatient 14 days, 2 weeks post followup visit ]
  2. Determine subjective effects produced by self administration of cocaine or placebo [ Time Frame: Days 4, 8, 12 and 13 ]
  3. Determine the effect of SYN117 of the pharmacokinetics of IV cocaine [ Time Frame: Days 3 and 11 ]
  4. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00656357

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)
Study Chair: Stephen Bandak, MD Biotie Therapies Inc.
Study Chair: F. Gerald Moeller, MD UTSW-Houston
Principal Investigator: Kathryn Cunningham, PhD UTMB-Galveston

Responsible Party: Biotie Therapies Inc.
ClinicalTrials.gov Identifier: NCT00656357     History of Changes
Other Study ID Numbers: SYN117-CL01
First Posted: April 11, 2008    Key Record Dates
Last Update Posted: January 19, 2018
Last Verified: August 2017

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Anesthetics, Local
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