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Completed

NCT Number: NCT00656357

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

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

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Key information

Conditions

Cocaine Dependence Chemically-Induced Disorders Cocaine-Related Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Texas Medical Branch (UTMB)

Galveston, Texas, 77555, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SYN117 Placebo

Drug

Placebo

SYN117 80 mg

Drug

SYN117 80 mg

SYN117 160 mg

Drug

SYN117 160 mg

Cocaine 10mg

Drug

IV Cocaine 10mg

Cocaine 20mg

Drug

IV Cocaine 20mg

Cocaine 40mg

Drug

IV Cocaine 40mg

Saline

Drug

IV Cocaine Placebo

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Biotie Therapies Inc.

Industry

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Apr 11, 2008
Registry last updated
Aug 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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