Trial · NCT03921151
5HT2CR Balance in Brain Connectivity in Cocaine Dependence
NCT03921151, Phase 1, Phase 2, Completed, Virginia Commonwealth University; results first posted 2021-11-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 5HT2CR Balance in Brain Connectivity in Cocaine Dependence. Trials, record NCT03921151. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03921151
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- 5HT2CR Balance in Brain Connectivity in Cocaine Dependence
- NCT number
- NCT03921151
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 90 participants, actual
- Lead sponsor
- Virginia Commonwealth University
- Conditions
- Cocaine Dependence
- Interventions
- Mirtazapine 15 MG Oral Tablet
- First posted
- 2019-04-19
- Last updated
- 2021-11-22
- Results first posted
- 2021-11-22
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. | Baseline to 1 week | Change in fMRI activation during Go/NoGo (impulsivity) task with placebo dose vs Mirtazapine dose. Brain activation measured using blood-oxygen-level dependent (BOLD) contrast |
| Secondary | Change in Interaction of the 5-HT2CR Cys23Ser SNP and a 5-HT2AR Antagonist on the Functional Circuitry Underlying Cue Reactivity | Baseline to 1 week | Change in fMRI activation during Attentional bias task with placebo dose vs Mirtazapine dose measured using whole brain blood oxygenation level dependent (BOLD) signal |
| Other | Change in Effective Connectivity Involved in the 5-HT2AR:5-HT2CR Homeostasis Impulsive Action | Baseline to 1 week | Change in Impulsivity as measured by Go/NoGo task with placebo dose vs Mirtazapine dose |
| Other | Change in Effective Connectivity Involved in the 5-HT2AR:5-HT2CR Homeostasis Cue Reactivity | Baseline to 1 week | Change in Cue reactivity as measured by Attentional bias task with placebo dose vs Mirtazapine dose |
| Other | Change in Explore Interactions Between Other 5-HT2CR SNPs and Brain Activation During Attentional Bias Task After a 5- HT2AR Antagonist | Baseline to 1 week | Change in fMRI activation with other 5-HT2CR SNPs during Attentional bias task with placebo dose vs Mirtazapine dose |
| Other | Change in Explore Interactions Between Other 5-HT2CR SNPs and Brain Activation During Go/NoGo (Impulsivity) Task After a 5- HT2AR Antagonist | Baseline to 1 week | Change in fMRI activation with other 5-HT2CR SNPs during Go/NoGo (impulsivity) task with placebo dose vs Mirtazapine dose |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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. | Baseline to 1 week | Change scores could not be calculated for 17 cocaine-dependent participants and 14 non-drug using participants due to a missing or unusable fMRI scan. | percent of whole brain BOLD signal | MEAN |
| SECONDARY | Change in Interaction of the 5-HT2CR Cys23Ser SNP and a 5-HT2AR Antagonist on the Functional Circuitry Underlying Cue Reactivity | Baseline to 1 week | Change scores could not be calculated for 12 cocaine-dependent participants and 9 non-drug using participants due to a missing or unusable fMRI scan. | percent of BOLD signal | MEAN |
| OTHER_PRE_SPECIFIED | Change in Effective Connectivity Involved in the 5-HT2AR:5-HT2CR Homeostasis Impulsive Action | Baseline to 1 week | |||
| OTHER_PRE_SPECIFIED | Change in Effective Connectivity Involved in the 5-HT2AR:5-HT2CR Homeostasis Cue Reactivity | Baseline to 1 week | |||
| OTHER_PRE_SPECIFIED | Change in Explore Interactions Between Other 5-HT2CR SNPs and Brain Activation During Attentional Bias Task After a 5- HT2AR Antagonist | Baseline to 1 week | |||
| OTHER_PRE_SPECIFIED | Change in Explore Interactions Between Other 5-HT2CR SNPs and Brain Activation During Go/NoGo (Impulsivity) Task After a 5- HT2AR Antagonist | Baseline to 1 week |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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. | Cocaine-dependent | 0.6889 | 90% Confidence Interval 0.2164 to 1.1614 | percent of whole brain BOLD signal | |
| 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. | Non-drug Using Healthy Controls | -1.1091 | 90% Confidence Interval -1.9063 to -0.3119 | percent of whole brain BOLD signal | |
| Change in Interaction of the 5-HT2CR Cys23Ser SNP and a 5-HT2AR Antagonist on the Functional Circuitry Underlying Cue Reactivity | Cocaine-dependent | -0.135 | 90% Confidence Interval -0.2998 to 0.0298 | percent of BOLD signal | |
| Change in Interaction of the 5-HT2CR Cys23Ser SNP and a 5-HT2AR Antagonist on the Functional Circuitry Underlying Cue Reactivity | Non-drug Using Healthy Controls | 0.2225 | 90% Confidence Interval -0.0926 to 0.5377 | percent of BOLD signal |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cocaine-dependent | 46 | |
| Overall Study | STARTED | Non-drug Using Healthy Controls | 44 | |
| Overall Study | COMPLETED | Cocaine-dependent | 35 | |
| Overall Study | COMPLETED | Non-drug Using Healthy Controls | 28 | |
| Overall Study | NOT COMPLETED | Cocaine-dependent | 11 | |
| Overall Study | NOT COMPLETED | Non-drug Using Healthy Controls | 16 |
Source ClinicalTrials.gov
Adverse events2
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea and dizziness | Gastrointestinal disorders | Cocaine-dependent | 0 | 35 | 0 |
| other | Nausea and dizziness | Gastrointestinal disorders | Non-drug Using Healthy Controls | 1 | 28 | 1 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cocaine-dependent | 0 | 35 |
| Total, all-cause mortality | Non-drug Using Healthy Controls | 0 | 28 |
| Total, other adverse events | Cocaine-dependent | 0 | 35 |
| Total, other adverse events | Non-drug Using Healthy Controls | 1 | 28 |
| Total, serious adverse events | Cocaine-dependent | 0 | 35 |
| Total, serious adverse events | Non-drug Using Healthy Controls | 0 | 28 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P20DA024157 | Translational Center on Serotonin and Stimulant Addiction | CUNNINGHAM, KATHRYN A. | UNIVERSITY OF TEXAS MED BR GALVESTON | NATIONAL INSTITUTE ON DRUG ABUSE | 2007 to 2012 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cocaine-dependent vs Non-drug Using Healthy Controls: deaths from any cause | Trial comparisons |
| Cocaine-dependent vs Non-drug Using Healthy Controls: serious adverse events | Trial comparisons |
Tests2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Go/No-Go Task | Primary outcome | ConductCognition |
| Food Cue Reactivity Task | Secondary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03921151
GET https://conductscience.org/api/trials/v1/NCT03921151/registered