Clinical trial NCT00656357: Study of Safety and Potential Efficacy of SYN117 in Cocaine Dependent Volunteers
Official title: A Human Laboratory Assessment of the Safety and Potential Efficacy of SYN117 (Nepicastat) in Cocaine-dependent Volunteers Receiving Cocaine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cocaine Dependence
Lead sponsor: Biotie Therapies Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2008-04-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
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.
timeFrame: inpatient 14 days with 2 week outpatient follow-up
Secondary outcomes:
measure: Determine tolerability by measuring adverse events
timeFrame: inpatient 14 days, 2 weeks post followup visit
measure: Determine subjective effects produced by self administration of cocaine or placebo
timeFrame: Days 4, 8, 12 and 13
measure: Determine the effect of SYN117 of the pharmacokinetics of IV cocaine
timeFrame: Days 3 and 11
measure: Determine if any baseline measures of impulsivity or drug use severity predict efficacy of SYN117 in reducing subjective effects of cocaine
timeFrame: Days 4, 8 and 12
Other outcomes:
Locations:
city: Galveston
country: United States
facility: University of Texas Medical Branch (UTMB)
state: Texas
Study officials:
affiliation: Biotie Therapies Inc.
name: Stephen Bandak, MD
role: STUDY_CHAIR
affiliation: UTSW-Houston
name: F. Gerald Moeller, MD
role: STUDY_CHAIR
affiliation: UTMB-Galveston
name: Kathryn Cunningham, PhD
role: PRINCIPAL_INVESTIGATOR
References: