5HT2CR Balance in Brain Connectivity in Cocaine Dependence
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ClinicalTrials.gov Identifier: NCT03921151 |
Recruitment Status :
Completed
First Posted : April 19, 2019
Last Update Posted : December 23, 2020
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Sponsor:
Virginia Commonwealth University
Collaborators:
The University of Texas Medical Branch, Galveston
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Virginia Commonwealth University
Tracking Information | |||||||
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First Submitted Date ICMJE | April 10, 2019 | ||||||
First Posted Date ICMJE | April 19, 2019 | ||||||
Last Update Posted Date | December 23, 2020 | ||||||
Actual Study Start Date ICMJE | May 13, 2014 | ||||||
Actual Primary Completion Date | January 24, 2019 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Change in Interaction of the serotonin receptor (5-HTR) type-2C Cys23Ser single nucleotide polymorphism (SNP) and a 5-HT2AR antagonist on the functional circuitry underlying impulsive action. [ Time Frame: Baseline to 1 week ] Change in fMRI activation during Go/NoGo (impulsivity) task with placebo dose vs Mirtazapine dose
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Original Primary Outcome Measures ICMJE |
Interaction of the serotonin receptor (5-HTR) type-2C Cys23Ser single nucleotide polymorphism (SNP) and a 5-HT2AR antagonist on the functional circuitry underlying impulsive action. [ Time Frame: 1 day ] fMRI activation during Go/NoGo (impulsivity) task with placebo dose vs Mirtazapine dose
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Change History | |||||||
Current Secondary Outcome Measures ICMJE |
Change in Interaction of the 5-HT2CR Cys23Ser SNP and a 5-HT2AR antagonist on the functional circuitry underlying cue reactivity [ Time Frame: Baseline to 1 week ] Change in fMRI activation during Attentional bias task with placebo dose vs Mirtazapine dose
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Original Secondary Outcome Measures ICMJE |
Interaction of the 5-HT2CR Cys23Ser SNP and a 5-HT2AR antagonist on the functional circuitry underlying cue reactivity [ Time Frame: 1 day ] fMRI activation during Attentional bias task with placebo dose vs Mirtazapine dose
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Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures |
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Descriptive Information | |||||||
Brief Title ICMJE | 5HT2CR Balance in Brain Connectivity in Cocaine Dependence | ||||||
Official Title ICMJE | 5-HT2AR: 5HT2CR Balance in Brain Connectivity in Cocaine Dependence | ||||||
Brief Summary | This project will evaluate the role of the 5-HT2CR:5-HT2AR balance in impulsive action and cue reactivity in cocaine-dependent subjects as compared to non-drug using controls. | ||||||
Detailed Description | The overall goal of this project is to evaluate the role of molecular interactions between 5-HT2AR and 5-HT2CR in behavioral phenotypes that confer risk for cocaine dependence and relapse. Specifically, this project will evaluate the role of the 5-HT2CR:5-HT2AR balance in impulsive action and cue reactivity in cocaine-dependent subjects as compared to non-drug using controls. Brain and behavioral responses to the 5-HT2AR blocking medication mirtazapine will be compared between subjects who have high and low functioning of the 5-HT2CR based on presence of a specific, functionally-relevant single nucleotide polymorphism (SNP) of the 5-HT2CR (Cys23Ser). The 5-HT2CR Cys23Ser SNP is thought to decrease the function of the protein and a preliminary observation indicates cocaine-dependent subjects carrying the CC genotype (Ser23 protein variant) display significantly higher cue reactivity. For Aims 1 and 2, two fMRI analysis methods will be used: 1) a voxelwise whole brain analysis; 2) a region of interest analysis based on proposed integrative circuitry shown in the model below. Because neuroimaging studies have shown that performance of impulsive action tasks and exposure to cocaine-associated cues (cue reactivity paradigms) activate brain regions in brain circuits in humans, impulsive action and cue reactivity may be engendered in related pathways. To explore this hypothesis, researchers will employ functional magnetic resonance imaging (fMRI)-based dynamic causal modeling (DCM) to ascertain the causal influences of one brain region over another. Employing DCM, researchers will uncover the effective connectivity within nodes of the neurocircuitry involved in impulsive action and cue reactivity. This project will parallel preclinical work studying the relationship between 5-HT2AR and 5-HT2CR on impulsive action and cue reactivity. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Triple (Participant, 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 * | 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 |
138 | ||||||
Original Estimated Enrollment ICMJE |
100 | ||||||
Actual Study Completion Date ICMJE | January 24, 2019 | ||||||
Actual Primary Completion Date | January 24, 2019 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria: Cocaine Dependent Subjects
Non-Drug Using Controls
Exclusion Criteria: Cocaine Dependent Subjects
Non-Drug Using Controls
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 60 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 | NCT03921151 | ||||||
Other Study ID Numbers ICMJE | HM15289 P20DA024157-04S1 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Virginia Commonwealth University | ||||||
Study Sponsor ICMJE | Virginia Commonwealth University | ||||||
Collaborators ICMJE |
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Investigators ICMJE |
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PRS Account | Virginia Commonwealth University | ||||||
Verification Date | December 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |