5HT2CR Balance in Brain Connectivity in Cocaine Dependence

• Status: Completed
• Trial end date: 2019-01-24
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Virginia Commonwealth University
• Collaborators: National Institute on Drug Abuse (NIDA); The University of Texas Medical Branch, Galveston
• Treatments: Cocaine; Mirtazapine

Criteria

Inclusion Criteria:

Cocaine Dependent Subjects

1. Be English-speaking volunteers

2. Be aged between 18 and 60 years

3. Meet DSM-5 criteria for cocaine dependence

4. Have a self-reported history of using cocaine

5. Have hematology and chemistry laboratory tests that are within reference limits ( 10%) with the following exceptions: hemoglobin and hematocrit within normal limits (for fMRI).

6. Have a baseline EKG that demonstrates clinically normal sinus rhythm, clinically normal conduction, and no clinically significant abnormalities

7. 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.

8. 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

1. Be English-speaking volunteers

2. Be aged between 18 and 60 years

3. 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.

4. Have hematology and chemistry laboratory tests that are within reference limits ( 10%), with the following exceptions: hemoglobin and hematocrit within normal limits (for fMRI)

5. Have a baseline EKG that demonstrates clinically normal sinus rhythm, clinically normal conduction, and no clinically significant abnormalities

6. 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.

7. 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

1. Have any history or evidence suggestive of seizure disorder or brain injury.

2. Have any previous medically adverse reaction to mirtazapine or other antidepressants.

3. 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.

4. Have evidence of uncontrolled clinically significant heart disease or hypertension, as determined by the PI.

5. Have evidence of non-psychiatric medical illness including neuroendocrine, autoimmune, renal, hepatic, or active infectious disease.

6. Use of any medications or drugs that can affect the central nervous system other than cocaine, marijuana, alcohol caffeine and nicotine.

7. Have a positive HIV test.

8. 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.

9. 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

1. Meet DSM-5 criteria for any current or past Axis I disorder.

2. Meet DSM-5 criteria for an Axis II diagnosis of Borderline or Antisocial Personality Disorder.

3. Have any history or evidence suggestive of seizure disorder or brain injury.

4. Have any previous medically adverse reaction to mirtazapine or other antidepressants.

5. Have evidence of uncontrolled clinically significant heart disease or hypertension, as determined by the PI.

6. Have evidence of medical illness including neuroendocrine, autoimmune, renal, hepatic, or active infectious disease.

7. Use of any medications or drugs that can affect the central nervous system other than caffeine or nicotine.

8. Have a positive HIV test.

9. 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.

10. 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.