Clinical Neurobiology of Serotonin and Addiction
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ClinicalTrials.gov Identifier: NCT00732901 |
Recruitment Status :
Completed
First Posted : August 12, 2008
Results First Posted : March 30, 2017
Last Update Posted : March 8, 2019
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Tracking Information | ||||
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First Submitted Date ICMJE | August 8, 2008 | |||
First Posted Date ICMJE | August 12, 2008 | |||
Results First Submitted Date ICMJE | July 20, 2016 | |||
Results First Posted Date ICMJE | March 30, 2017 | |||
Last Update Posted Date | March 8, 2019 | |||
Study Start Date ICMJE | June 2008 | |||
Actual Primary Completion Date | February 2013 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Immediate Memory Task [ Time Frame: after acute dose and after chronic administration ] The IMT was used to measure impulsivity. The IMT is a continuous performance test. Subjects were instructed to respond on the computer's left mouse button when a five-digit number the target stimulus appeared that was exactly like the preceding stimulus. A catch stimulus was a number that differed only slightly from the preceding number. Only one of the five digits was changed its position and value was determined randomly. Responses errors made to catch stimuli were considered commission errors or 'false alarms'. Immediate Memory Task Commission Errors to catch stimuli were the primary measure of impulsivity in this study. Scale is percentage of overall responses to a catch stimulus that were commission errors, ranging from 0 to 100. Zero would equate to no impulsivity and 100 would equate to 100% impulsive responses.
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Original Primary Outcome Measures ICMJE |
impulsivity [ Time Frame: 5 weeks of treatment ] | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Clinical Neurobiology of Serotonin and Addiction | |||
Official Title ICMJE | Project 1: Clinical Neurobiology of Serotonin and Addiction | |||
Brief Summary | The purpose of this study is to examine the relationship between 5-HT2R function, impulsivity and cue reactivity in cocaine dependent subjects and healthy controls and examine specific effects of escitalopram and mirtazapine on impulsivity and cue reactivity in human cocaine users. | |||
Detailed Description | Specific Aim 1: We will test the hypothesis that cocaine-dependent subjects will exhibit greater impulsivity than controls as determined by a battery of impulsivity measures and that impulsivity will be associated with specific profiles of 5-HT2AR and/or 5-HT2CR expression in platelets. We predict that treatment of cocaine-dependent subjects with escitalopram and/or mirtazapine will reduce impulsivity and cocaine-positive urines, in concert with a normalized balance of platelet 5-HT2AR and/or 5-HT2CR expression. Specific Aim 2: We will test the hypothesis that cocaine-dependent subjects will exhibit greater cue reactivity than controls as determined by a modified Stroop task, and that cue reactivity will be associated with specific profiles of 5-HT2AR and/or 5-HT2CR expression in platelets. We predict that treatment of cocaine-dependent subjects with escitalopram and/or mirtazapine will reduce cue reactivity and cocaine-positive urines, in concert with a normalized balance of platelet 5-HT2AR and/or 5-HT2CR expression. Specific Aim 3: We will test the hypothesis that specific polymorphisms in the 5-HT2AR and/or 5-HT2CR will predict baseline impulsivity and/or cue reactivity as well as treatment response to serotonergic medications in cocaine-dependent subjects. |
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Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 Phase 3 |
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Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Basic Science |
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Condition ICMJE | Cocaine Dependence | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* 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 |
160 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | February 2013 | |||
Actual Primary Completion Date | February 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 55 Years (Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
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 | NCT00732901 | |||
Other Study ID Numbers ICMJE | HM15289 - 2 P20DA024157 ( U.S. NIH Grant/Contract ) DA 024157 ( Other Identifier ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Virginia Commonwealth University | |||
Original Responsible Party | Frederick Gerard Moeller, MD, The University of Texas Health Science Center-Houston | |||
Current Study Sponsor ICMJE | Virginia Commonwealth University | |||
Original Study Sponsor ICMJE | National Institute on Drug Abuse (NIDA) | |||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Virginia Commonwealth University | |||
Verification Date | June 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |