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
|Condition or disease||Intervention/treatment||Phase|
|Cocaine Dependence||Drug: Escitalopram Drug: Placebo||Phase 2 Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Project 1: Clinical Neurobiology of Serotonin and Addiction|
|Study Start Date :||June 2008|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||February 2013|
Experimental: A (escitalopram)
Escitalopram: once daily 10 mg on days 1-3, 20 mg on days 4-24 and 10 mg on days 25-28
Other Name: Lexapro
Experimental: B (placebo)
Once daily days 1-28
- 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.
- Attentional Bias as Measured by the Cocaine Stroop Task. [ Time Frame: 5 weeks of treatment ]Attentional bias is the difference in reaction time to cocaine related words and neutral words. A slower reaction time indicates greater attentional bias.
- Cocaine Positive Urines [ Time Frame: 5 weeks of treatment ]Number of urine drug screens positive for cocaine metabolite benzoylecgonine.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00732901
|United States, Texas|
|University of Texas Health Science Center-Houston; Substance Abuse Research Clinic|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Frederick G Moeller, MD||The University of Texas Health Science Center, Houston|