Study of Safety and Potential Efficacy of SYN117 in Cocaine Dependent Volunteers - Full Text View

Sponsors and Collaborators:	Synosia Therapeutics, Inc. NIDA (cocaine)
Information provided by:	Synosia Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT00656357

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 I Phase II

Drug Information available for: 8-Azabicyclo(3.2.1)octane-2-carboxylic acid, 3-(benzoyloxy)-8-methyl-, methyl ester, (1R-(exo,exo))- Cocaine hydrochloride Nepicastat

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	A Human Laboratory Assessment of the Safety and Potential Efficacy of SYN117 (Nepicastat) in Cocaine-Dependent Volunteers Receiving Cocaine

Further study details as provided by Synosia Therapeutics, 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 ]

Estimated Enrollment:	16
Study Start Date:	June 2008
Estimated Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Placebo Comparator SYN117 placebo and Ascending doses of cocaine (10, 20, 40 mg) and placebo	Drug: SYN117 SYN117 placebo
B: Experimental 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

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

Contacts

Contact: Crystal Carbone	409-392-3647	clcarbon@utmb.edu
Contact: Kathryn Cunningham, PhD	409-772-9640	kcunning@utmb.edu

Locations

United States, Texas
University of Texas Medical Branch (UTMB)	Recruiting
Galveston, Texas, United States, 77555
Principal Investigator: Kathryn Cunningham, PhD
Sub-Investigator: David Ware, MD
Sub-Investigator: Michael Fuller, MD
Sub-Investigator: Karen Smith, PhD

Sponsors and Collaborators

Synosia Therapeutics, Inc.

NIDA (cocaine)

Investigators

Study Director:	Ann C Neale, RN	Synosia Therapeutics, Inc.
Study Chair:	F. Gerald Moeller, MD	UTSW-Houston
Principal Investigator:	Kathryn Cunningham, PhD	UTMB-Galveston

More Information

Responsible Party:	Synosia Therapeutics ( Dr. Steve Bandak Chief Medical Officer )
Study ID Numbers:	SYN117-CL01
Study First Received:	April 4, 2008
Last Updated:	November 4, 2008
ClinicalTrials.gov Identifier:	NCT00656357
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Cocaine-Related Disorders
Dopamine
Mental Disorders

Substance-Related Disorders
Disorders of Environmental Origin
Cocaine

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anesthetics
Central Nervous System Depressants
Cardiovascular Agents

Pharmacologic Actions
Anesthetics, Local
Sensory System Agents
Therapeutic Uses
Vasoconstrictor Agents
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009