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Report for Clinical Trial NCT03921151

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

5-HT2AR: 5HT2CR Balance in Brain Connectivity in Cocaine Dependence

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.

NCT03921151 Cocaine Dependence
MeSH:Cocaine-Related Disorders

2 Interventions

Name: Mirtazapine 15 MG Oral Tablet

Description: 15mg of mirtazapine oral table prior to scan
Type: Drug
Group Labels: 2

Cocaine-dependent Non-drug

Name: Placebo oral capsule

Description: Oral placebo consisting of dextrose in gelatin capsule prior to scan
Type: Other
Group Labels: 2

Cocaine-dependent Non-drug


Primary Outcomes

Description: Change in fMRI activation during Go/NoGo (impulsivity) task with placebo dose vs Mirtazapine dose

Measure: 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: Baseline to 1 week

Secondary Outcomes

Description: Change in fMRI activation during Attentional bias task with placebo dose vs Mirtazapine dose

Measure: Change in Interaction of the 5-HT2CR Cys23Ser SNP and a 5-HT2AR antagonist on the functional circuitry underlying cue reactivity

Time: Baseline to 1 week

Other Outcomes

Description: Change in Impulsivity as measured by Go/NoGo task with placebo dose vs Mirtazapine dose

Measure: Change in Effective connectivity involved in the 5-HT2AR:5-HT2CR homeostasis impulsive action

Time: Baseline to 1 week

Description: Change in Cue reactivity as measured by Attentional bias task with placebo dose vs Mirtazapine dose

Measure: Change in Effective connectivity involved in the 5-HT2AR:5-HT2CR homeostasis cue reactivity

Time: Baseline to 1 week

Description: Change in fMRI activation with other 5-HT2CR SNPs during Attentional bias task with placebo dose vs Mirtazapine dose

Measure: Change in Explore interactions between other 5-HT2CR SNPs and brain activation during attentional bias task after a 5- HT2AR antagonist

Time: Baseline to 1 week

Description: Change in fMRI activation with other 5-HT2CR SNPs during Go/NoGo (impulsivity) task with placebo dose vs Mirtazapine dose

Measure: Change in Explore interactions between other 5-HT2CR SNPs and brain activation during Go/NoGo (impulsivity) task after a 5- HT2AR antagonist

Time: Baseline to 1 week

Purpose: Basic Science

Allocation: Randomized

Crossover Assignment


There is one SNP

SNPs


1 C23S

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.. Change in fMRI activation during Go/NoGo (impulsivity) task with placebo dose vs Mirtazapine dose. --- Cys23Ser ---

Change in Interaction of the 5-HT2CR Cys23Ser SNP and a 5-HT2AR antagonist on the functional circuitry underlying cue reactivity. --- Cys23Ser ---

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). --- 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. --- Cys23Ser ---



HPO Nodes