The Role of Neuroactive Steroids in Stress, Drug Craving and Drug Use in Cocaine Use Disorders
Cocaine-Related Disorders
About this trial
This is an interventional treatment trial for Cocaine-Related Disorders
Eligibility Criteria
Inclusion Criteria:
- Male or female individuals, ages 18 to 60.
- Subjects must meet current DSM-V criteria for cocaine use disorder; documented positive urine toxicology screen for cocaine at intake or collateral information from family members, significant others, room-mates etc., on recent use.
- Subject has voluntarily given informed consent and signed the informed consent document.
- Able to read English and complete study evaluations.
Exclusion Criteria:
- Women who are pregnant, or nursing or are of childbearing potential and not practicing an effective means of birth control.
- Meet current criteria for use disorder on another psychoactive substance, such as, heroin, amphetamines, hallucinogens/PCP, excluding alcohol and nicotine.
- Any current use of opiates or past history of opiate use disorder.
- Current use of any psychoactive drugs, including anxiolytics, antidepressants, naltrexone or antabuse.
- Any psychotic disorder or current Axis I psychiatric symptoms requiring specific attention, including need for psychiatric medications for current major depression and anxiety disorders.
- Significant underlying medical conditions such as cerebral, renal, thyroid or cardiac pathology which in the opinion of study physician would preclude patient from fully cooperating or be of potential harm during the course of the study.
- Abstinent from cocaine for more than two weeks prior to admission.
- Hypotensive individuals with sitting blood pressure below 90/50 mmHG.
Sites / Locations
- Yale Stress CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
patients receiving PREG
patients receiving placebo
Eligible participants will be randomly assigned to 2 doses of PREG (300/500 mg/day) over 8 weeks with a) an inpatient-outpatient option where they will be admitted to the Clinical Neuroscience Research Unit (CNRU) at the Connecticut Mental Health Center (CMHC) for first two weeks and then outpatient at Yale Stress Center (YSC) for the remaining 6 weeks, or b) an outpatient option where they will participate in the entire study outpatient at YSC.
Eligible participants will be randomly assigned to a placebo (PLA) treatment over 8 weeks with a) an inpatient-outpatient option where they will be admitted to the Clinical Neuroscience Research Unit (CNRU) at the Connecticut Mental Health Center (CMHC) for the first two weeks and then transition to outpatient at Yale Stress Center (YSC) for the remaining 6 weeks, or b) an outpatient only option where they will participate in the entire study outpatient at YSC.