Study of Safety and Potential Efficacy of SYN117 in Cocaine Dependent Volunteers
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ClinicalTrials.gov Identifier: NCT00656357 |
Recruitment Status
:
Completed
First Posted
: April 11, 2008
Last Update Posted
: January 19, 2018
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Sponsor:
Biotie Therapies Inc.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Biotie Therapies Inc.
Tracking Information | ||||||||||
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First Submitted Date ICMJE | April 4, 2008 | |||||||||
First Posted Date ICMJE | April 11, 2008 | |||||||||
Last Update Posted Date | January 19, 2018 | |||||||||
Actual Study Start Date ICMJE | June 2008 | |||||||||
Actual 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 |
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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 |
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Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Cocaine Dependence | |||||||||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | |||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||||||||
Recruitment Status ICMJE | Completed | |||||||||
Actual Enrollment ICMJE |
20 | |||||||||
Original Estimated Enrollment ICMJE |
16 | |||||||||
Actual Study Completion Date | May 2009 | |||||||||
Actual Primary Completion Date | May 2009 (Final data collection date for primary outcome measure) | |||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 50 Years (Adult) | |||||||||
Accepts Healthy Volunteers | No | |||||||||
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 | |||||||||
IPD Sharing Statement | Not Provided | |||||||||
Responsible Party | Biotie Therapies Inc. | |||||||||
Study Sponsor ICMJE | Biotie Therapies Inc. | |||||||||
Collaborators ICMJE | National Institute on Drug Abuse (NIDA) | |||||||||
Investigators ICMJE |
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PRS Account | Biotie Therapies Inc. | |||||||||
Verification Date | August 2017 | |||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |