Study of Safety and Potential Efficacy of SYN117 in Cocaine Dependent Volunteers
This study has been completed.
Sponsor:
Biotie Therapies Inc.
Collaborator:
Information provided by:
Biotie Therapies Inc.
ClinicalTrials.gov Identifier:
NCT00656357
First received: April 4, 2008
Last updated: December 3, 2009
Last verified: December 2009
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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 |
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
SYN117 placebo
Other Name: SYN117 Placebo and ascending doses of cocaine (10mg, 20mg, 40mg) and 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
SYN117 ascending doses placebo, 80 mg and 160 mg
Other Name: ascending doses of cocaine(10mg, 20mg, 40mg) and placebo
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| 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
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.
Investigators
| Study Director: | Ann C Neale, RN | Biotie Therapies Inc. |
| Study Chair: | F. Gerald Moeller, MD | UTSW-Houston |
| Principal Investigator: | Kathryn Cunningham, PhD | UTMB-Galveston |
More Information
No publications provided
| Responsible Party: | Dr. Steve Bandak Chief Medical Officer, Synosia Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00656357 History of Changes |
| Other Study ID Numbers: | SYN117-CL01 |
| Study First Received: | April 4, 2008 |
| Last Updated: | December 3, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Cocaine-Related Disorders Substance-Related Disorders Mental Disorders Cocaine Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions Dopamine Uptake Inhibitors Dopamine Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs Anesthetics, Local Anesthetics Central Nervous System Depressants Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 16, 2013