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

This study has been completed.

Sponsor:

Collaborator:

National Institute on Drug Abuse (NIDA)

Information provided by (Responsible Party):

Biotie Therapies Inc.

ClinicalTrials.gov Identifier:

NCT00656357

First received: April 4, 2008

Last updated: March 9, 2016

Last verified: February 2014

History of Changes

Tracking Information

First Received Date ^ICMJE

April 4, 2008

Last Updated Date

March 9, 2016

Start Date ^ICMJE

June 2008

Primary Completion Date

May 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00656357 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Determine tolerability by measuring adverse events [ Time Frame: inpatient 14 days, 2 weeks post followup visit ]
Determine subjective effects produced by self administration of cocaine or placebo [ Time Frame: Days 4, 8, 12 and 13 ]
Determine the effect of SYN117 of the pharmacokinetics of IV cocaine [ Time Frame: 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 [ Time Frame: Days 4, 8 and 12 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Cocaine Dependence

Intervention ^ICMJE

Drug: SYN117 Placebo
Placebo
Drug: SYN117 80 mg
SYN117 80 mg
Drug: SYN117 160 mg
SYN117 160 mg
Drug: Cocaine 10mg
IV Cocaine 10mg
Drug: Cocaine 20mg
IV Cocaine 20mg
Drug: Cocaine 40mg
IV Cocaine 40mg
Drug: Saline
IV Cocaine Placebo

Study Arms

Placebo Comparator: A
SYN117 placebo and Ascending doses of cocaine (10, 20, 40 mg) and placebo
Interventions:
- Drug: SYN117 Placebo
- Drug: Cocaine 10mg
- Drug: Cocaine 20mg
- Drug: Cocaine 40mg
- Drug: Saline
Experimental: B
Ascending doses of SYN117 (placebo, 80 mg, 160 mg) and ascending doses of cocaine (10 mg, 20 mg, 40 mg) and placebo
Interventions:
- Drug: SYN117 80 mg
- Drug: SYN117 160 mg
- Drug: Cocaine 10mg
- Drug: Cocaine 20mg
- Drug: Cocaine 40mg
- Drug: Saline

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Not Provided

Primary Completion Date

May 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years to 50 Years (Adult)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00656357

Other Study ID Numbers ^ICMJE

SYN117-CL01

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Not Provided

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Biotie Therapies Inc.

Study Sponsor ^ICMJE

Biotie Therapies Inc.

Collaborators ^ICMJE

National Institute on Drug Abuse (NIDA)

Investigators ^ICMJE

Study Chair:	Stephen Bandak, MD	Biotie Therapies Inc.
Study Chair:	F. Gerald Moeller, MD	UTSW-Houston
Principal Investigator:	Kathryn Cunningham, PhD	UTMB-Galveston

PRS Account

Biotie Therapies Inc.

Verification Date

February 2014

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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