| Eligibility Criteria: |
Inclusion Criteria:
1. An informed consent document voluntarily signed and dated by the subject.
2. Physically healthy males and females, aged 18-60 years old, who meet criteria for
cocaine use disorder (based on DSM-V criteria) as their primary diagnosis and are
voluntarily seeking treatment.
3. Females must be non-pregnant, non-lactating, and either be of non-childbearing
potential (e.g., sterilized via hysterectomy or bilateral tubal ligation or at least 1
year post-menopausal) or of childbearing potential, but practicing a medically
acceptable method of birth control.
4. Subject must read at or above eighth grade level and speak, understand, and write in
English.
5. Intelligence quotient of ≥ 80.
6. Smoking must be a primary route of cocaine self-administration.
7. In the past 30 days, used no less than $100-worth of cocaine.
8. Subjects who are willing and able to comply with scheduled visits, treatment plan,
laboratory tests, and other study procedures.
9. Available for an inpatient stay.
Exclusion Criteria:
1. Participation in a clinical trial and receipt of investigational drug(s) during 30
days prior to the research study, except as explicitly approved by the Principal
Investigator.
2. Meets DSM-V criteria for moderate to severe Substance Use Disorder for any substance
other than cocaine, alcohol, marijuana or nicotine as determined by the
semi-structured interview. Patients with comorbid Alcohol Use Disorder will be
accepted if their alcohol use disorder is not severe enough to require a medicated
alcohol detoxification.
3. Meets current or lifetime DSM-V criteria for schizophrenia or any psychotic disorder,
or organic mental disorder, including dementia-related psychosis.
4. Meets current DSM-V criteria for severe Major Depressive Disorder (mild and moderate
MDD as well as in stable remission are allowed, if no suicidal risk and no ongoing
antidepressant therapy).
5. Current comorbid GAD, Social Phobia, Specific Phobia are excluded if in current
treatment and/or clinically unstable.
6. Current and/or in treatment for Panic Disorder With or Without Agoraphobia,
Agoraphobia Without Panic Disorder, Post-Traumatic Stress Disorder.
7. Presence of any other psychiatric disorder that in the opinion of the PI will
interfere with completion of the study or place the patient at heightened risk through
participation in the study.
8. Actively suicidal or present suicidal risk or who reports a lifetime history of
serious or recurrent suicidal behavior, or who has an SBQ-R total score ≥8 at
Screening, and/or "yes" answers on items 4 or 5 of the C-SSRS, or in the
investigator's clinical judgment presents a risk.
9. Has evidence of a history of significant active hepatitis, significant hepatocellular
injury as evidenced by elevated bilirubin levels (>1.3), or other clinically
significant hepatic, pulmonary, endocrine, cardiovascular, renal (creatine clearance
less than 30mL/min) or gastrointestinal disease, or current AIDS, and/or clinically
significant levels (over 3.5x upper limit of normal) of aspartate aminotransferase
(AST), and serum alanine aminotransferase (ALT).
10. History of stroke, serious head trauma or injury causing loss of consciousness that
lasted more than 3 minutes and/or associated with skull fracture or intra-cranial
bleeding or abnormal MRI.
11. History of seizures.
12. Presence of magnetically active prosthetics, plates, pins, broken needles, permanent
retainer, bullets, etc. in patient's body (unless a radiologist confirms that its
presence is unproblematic). An x-ray may be obtained to determine eligibility.
13. Claustrophobia or other medical condition that disables the participant from lying in
the MRI for approximately 60 minutes.
14. Current or prior gambling problems (assessed by subjects self-report).
15. Non-removable skin patches, at discretion of PI.
16. Has received medication that could interact adversely with cariprazine within the time
of administration of study agent based on the study physician's guidance.
17. Needs treatment with any psychoactive medications (with the exception of Benadryl used
sparingly, if necessary, for sleep).
18. Has demonstrated hypersensitivity to cariprazine or any ingredients in VRAYLAR
capsules.
19. Currently taking a CYP3A4 inhibitor/inducer.
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