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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00656357

Enrollment

Registered

2008-04-11

Start date

2008-06-30

Completion date

2009-05-31

Last updated

2018-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cocaine Dependence

Brief summary

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

Interventions

DRUGCocaine 10mg

IV Cocaine 10mg

DRUGCocaine 20mg

IV Cocaine 20mg

DRUGCocaine 40mg

IV Cocaine 40mg

DRUGSYN117 Placebo

Placebo

DRUGSYN117 80 mg

SYN117 80 mg

DRUGSYN117 160 mg

SYN117 160 mg

DRUGSaline

IV Cocaine Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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.	inpatient 14 days with 2 week outpatient follow-up

Secondary

Measure	Time frame
Determine tolerability by measuring adverse events	inpatient 14 days, 2 weeks post followup visit
Determine subjective effects produced by self administration of cocaine or placebo	Days 4, 8, 12 and 13
Determine the effect of SYN117 of the pharmacokinetics of IV cocaine	Days 3 and 11
Determine if any baseline measures of impulsivity or drug use severity predict efficacy of SYN117 in reducing subjective effects of cocaine	Days 4, 8 and 12

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026