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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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cocaine Dependence | Drug: Mirtazapine 15 MG Oral Tablet Other: Placebo oral capsule | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 138 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Basic Science |
Official Title: | 5-HT2AR: 5HT2CR Balance in Brain Connectivity in Cocaine Dependence |
Actual Study Start Date : | May 13, 2014 |
Actual Primary Completion Date : | January 24, 2019 |
Actual Study Completion Date : | January 24, 2019 |

Arm | Intervention/treatment |
---|---|
Cocaine-dependent
Participants who use and are dependent on cocaine
|
Drug: Mirtazapine 15 MG Oral Tablet
15mg of mirtazapine oral table prior to scan
Other Name: Remeron Other: Placebo oral capsule Oral placebo consisting of dextrose in gelatin capsule prior to scan
Other Name: Dextrose placebo in gelatin capsule |
Non-drug
Participants who are not drug users
|
Drug: Mirtazapine 15 MG Oral Tablet
15mg of mirtazapine oral table prior to scan
Other Name: Remeron Other: Placebo oral capsule Oral placebo consisting of dextrose in gelatin capsule prior to scan
Other Name: Dextrose placebo in gelatin capsule |
- 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
- 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
- Change in Effective connectivity involved in the 5-HT2AR:5-HT2CR homeostasis impulsive action [ Time Frame: Baseline to 1 week ]Change in Impulsivity as measured by Go/NoGo task with placebo dose vs Mirtazapine dose
- Change in Effective connectivity involved in the 5-HT2AR:5-HT2CR homeostasis cue reactivity [ Time Frame: Baseline to 1 week ]Change in Cue reactivity as measured by Attentional bias task with placebo dose vs Mirtazapine dose
- Change in Explore interactions between other 5-HT2CR SNPs and brain activation during attentional bias task after a 5- HT2AR antagonist [ Time Frame: Baseline to 1 week ]Change in fMRI activation with other 5-HT2CR SNPs during Attentional bias task with placebo dose vs Mirtazapine dose
- Change in Explore interactions between other 5-HT2CR SNPs and brain activation during Go/NoGo (impulsivity) task after a 5- HT2AR antagonist [ Time Frame: Baseline to 1 week ]Change in fMRI activation with other 5-HT2CR SNPs during Go/NoGo (impulsivity) task with placebo dose vs Mirtazapine dose

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Cocaine Dependent Subjects
- Be English-speaking volunteers
- Be aged between 18 and 60 years
- Meet DSM-5 criteria for cocaine dependence
- Have a self-reported history of using cocaine
- Have hematology and chemistry laboratory tests that are within reference limits ( 10%) with the following exceptions: hemoglobin and hematocrit within normal limits (for fMRI).
- Have a baseline EKG that demonstrates clinically normal sinus rhythm, clinically normal conduction, and no clinically significant abnormalities
- Have a medical history and physical examination demonstrating no clinically significant contraindications for study participation, in the judgment of the admitting physician and the principal investigator.
- Have no metal fragments or other bodily metal (e.g., pacemaker) or significant claustrophobia that would put the subjects at risk for MRI scanning.
Non-Drug Using Controls
- Be English-speaking volunteers
- Be aged between 18 and 60 years
- Have no past history of Psychiatric or non-Psychiatric medical disorders which could affect the central nervous system as assessed by SCID and physical examination.
- Have hematology and chemistry laboratory tests that are within reference limits ( 10%), with the following exceptions: hemoglobin and hematocrit within normal limits (for fMRI)
- Have a baseline EKG that demonstrates clinically normal sinus rhythm, clinically normal conduction, and no clinically significant abnormalities
- Have a medical history and brief physical examination demonstrating no clinically significant contraindications for study participation, in the judgment of the admitting physician and the Principal investigator.
- Have no metal fragments or other bodily metal (pacemaker) or significant claustrophobia that would put the subjects at risk for MRI scanning
Exclusion Criteria:
Cocaine Dependent Subjects
- Have any history or evidence suggestive of seizure disorder or brain injury.
- Have any previous medically adverse reaction to mirtazapine or other antidepressants.
- Have neurological or psychiatric disorders, such as (a) psychosis, bipolar illness or major depression as assessed by SCID; (b) organic brain disease or dementia assessed by clinical interview; (c) history of any psychiatric disorder that would require ongoing treatment or that would make study compliance difficult; and (d) history of suicide attempts within the past 3 months and/or current suicidal ideation/plan.
- Have evidence of uncontrolled clinically significant heart disease or hypertension, as determined by the PI.
- Have evidence of non-psychiatric medical illness including neuroendocrine, autoimmune, renal, hepatic, or active infectious disease.
- Use of any medications or drugs that can affect the central nervous system other than cocaine, marijuana, alcohol caffeine and nicotine.
- Have a positive HIV test.
- Be pregnant or nursing. Other females must either be unable to conceive (i.e., surgically sterilized, sterile, or postmenopausal) or be using a reliable form of contraception (e.g., abstinence, birth control pills, intrauterine device, condoms, or spermicide). All females must provide negative pregnancy urine tests before study entry, weekly during the study, and at the end of study participation.
- Have any other illness, condition, or use of psychotropic medications, which in the opinion of the PI and/or the admitting physician would preclude safe and/or successful completion of the study.
Non-Drug Using Controls
- Meet DSM-5 criteria for any current or past Axis I disorder.
- Meet DSM-5 criteria for an Axis II diagnosis of Borderline or Antisocial Personality Disorder.
- Have any history or evidence suggestive of seizure disorder or brain injury.
- Have any previous medically adverse reaction to mirtazapine or other antidepressants.
- Have evidence of uncontrolled clinically significant heart disease or hypertension, as determined by the PI.
- Have evidence of medical illness including neuroendocrine, autoimmune, renal, hepatic, or active infectious disease.
- Use of any medications or drugs that can affect the central nervous system other than caffeine or nicotine.
- Have a positive HIV test.
- Be pregnant or nursing. Other females must either be unable to conceive (i.e., surgically sterilized, sterile, or postmenopausal) or be using a reliable form of contraception (e.g., abstinence, birth control pills, intrauterine device, condoms, or spermicide). All females must provide negative pregnancy urine tests before study entry, weekly during the study, and at the end of study participation.
- Have any other illness, condition, or use of psychotropic medications, which in the opinion of the PI and/or the admitting physician would preclude safe and/or successful completion of the study.

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): NCT03921151
United States, Virginia | |
Virginia Commonwealth University | |
Richmond, Virginia, United States, 23298 |
Principal Investigator: | Frederick Moeller, M.D. | Virginia Commonwealth University |
Responsible Party: | Virginia Commonwealth University |
ClinicalTrials.gov Identifier: | NCT03921151 |
Other Study ID Numbers: |
HM15289 P20DA024157-04S1 ( U.S. NIH Grant/Contract ) |
First Posted: | April 19, 2019 Key Record Dates |
Last Update Posted: | December 23, 2020 |
Last Verified: | December 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Cocaine-Related Disorders Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Mirtazapine Antidepressive Agents Psychotropic Drugs Histamine H1 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
Physiological Effects of Drugs Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Adrenergic alpha-2 Receptor Antagonists Adrenergic alpha-Antagonists Adrenergic Antagonists Adrenergic Agents Serotonin 5-HT2 Receptor Antagonists Serotonin Antagonists Serotonin Agents Serotonin 5-HT3 Receptor Antagonists |