Neural Substrates of Emotion: Impact of Cocaine Dependence
Cocaine Use Disorder
About this trial
This is an interventional treatment trial for Cocaine Use Disorder
Eligibility Criteria
General Inclusion/Exclusion Criteria Inclusion Criteria
- Age 18-65.
- Subjects must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
- Subjects must consent to remain abstinent from all drugs of abuse (except nicotine) for the three-day period immediately prior to the study visit.
- Subjects must consent to random assignment.
- Subjects must have a negative breathalyzer, urine drug screen at the study visit.
- Subjects must consent to the study visit which includes an outpatient visit to the ASD and completing one functional magnetic resonance imaging (fMRI) scanning session.
Exclusion Criteria
- Subjects with evidence of or a history of significant hematological, endocrine, cardiovascular, pulmonary, renal, gastrointestinal, or neurological disease including diabetes.
- Subjects with a history of or current psychotic disorder or bipolar affective disorder.
- Subjects with current major depressive disorder or post-traumatic stress disorder.
- Subjects taking any psychotropic medications, including SSRI's or other antidepressants, opiates or opiate antagonists. Subjects taking trazodone or non-benzodiazepene hypnotics for sleep will be included.
- Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control.
- Subjects who have a BMI that procludes them from fitting comfortably in the scanner.
- Persons with ferrous metal implants or pacemaker.
- Subjects that are claustrophobic.
- Subjects with significant psychiatric or medical problems that would impair participation or limit ability to complete the scanning session.
- Subjects that require maintenance or acute treatment with any psychoactive medication including anti-seizure medications which could potentially interfere with fMRI data acquisition.
Group - Specific Inclusion/Exclusion Criteria Individuals with Cocaine Dependence Inclusion Criteria
1. Subjects must meet DSM-5 criteria for current (three months prior to study visit) moderate to severe cocaine use disorder. Individuals may meet criteria for mild marijuana use disorder, but they must not meet criteria for substance use disorder for any other substance (except nicotine) within the 60 days prior to study participation. Due to the high comorbidity of alcohol and cocaine use disorder individuals with alcohol use disorder will be included in the study if they do not require medically supervised detoxification.
Exclusion Criteria 1. Subjects meeting DSM-5 criteria for substance use disorder (other than nicotine, cocaine, marijuana or alcohol) within the 60 days prior to study participation.
Healthy Controls Inclusion Criteria
1. As above. Exclusion Criteria
- Subjects meeting DSM-5 criteria for current or lifetime substance use disorder on any drugs of abuse (except nicotine and marijuana.
- Subjects meeting DSM-5 criteria for marijuana use disorder within the last year.
- Subjects with current major depression or post-traumatic stress disorder (past month)
Sites / Locations
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Active Comparator
Experimental
Active Comparator
Oxytocin/Cocaine User
Placebo/Cocaine User
Oxytocin/Control
Placebo/Control
Individuals who meet criteria for cocaine use disorder and are randomized to oxytocin.
Individuals who meet criteria for cocaine use disorder and are randomized to placebo.
Healthy controls who are randomized to oxytocin.
Healthy controls who are randomized to placebo.