Eligibility Details:
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.
common.study.methods.has-drugs-yes
common.study.methods.is-healthy-no
