Behavioral Effects of Drugs (Inpatient): 43 (Opioids, Cocaine, n-Acetylcysteine) (BED IN 43)
Cocaine Use Disorder, Opioid Use Disorder
About this trial
This is an interventional basic science trial for Cocaine Use Disorder
Eligibility Criteria
Inclusion Criteria: Between the ages of 18 and 55 years, Report recent use of opioids and cocaine and must not be seeking treatment for their drug use, Be physically dependent on short-acting opioids, Meet Diagnostic and Statistical Manual (DSM)-5 diagnostic criteria for current opioid use disorder (OUD) and current or past cocaine use disorder (CUD) and have either a urine sample positive for recent opioid use during each visit or if opioid negative, displaying frank withdrawal during screening Other than the diagnosis for opioid and cocaine use disorder at the time of the screening, subjects must be healthy, Laboratory chemistries (e.g., blood chemistry screen, complete blood count, urinalysis) and electrocardiogram (ECG) results must be normal or within normal range and any abnormal results must be considered as not clinically significant by the study physicians, No contraindications to magnetic resonance imagining (MRI; e.g., metallic objects in their body, BMI > or = 40, claustrophobia) will be considered ineligible, Female subjects must be using an effective form of birth control (e.g., birth control pills, surgical sterilization, intrauterine device, barrier method, condoms with spermicide, cervical cap with a spermicide or abstinence) to participate and must not be pregnant, All study subjects will be judged by the medical staff to be psychiatrically and physically healthy. Exclusion Criteria: Any potential subject with a history of serious physical disease, current physical disease (e.g., impaired cardiovascular functioning, histories of seizure, head trauma, diabetes, asthma, or central nervous system [CNS] tumors) or current or past histories of serious psychiatric disorder (e.g., schizophrenia) that would limit compliance in the study, other than substance use disorder, will be excluded from research participation, Potential subjects that meet diagnostic criteria for moderate - severe substance use disorder for substances other than opioids, stimulants, cannabis, or nicotine at the time of the interview will not be eligible for study participation, Subjects who report a positive first-degree family history of schizophrenia, serious cardiovascular disease, or seizure disorders will also be excluded from research participation. Subjects with contraindications to hydromorphone or n-acetylcysteine will not be eligible.
Sites / Locations
- University of Kentucky Laboratory of Human Behavioral PharmacologyRecruiting
- University of Kentucky Department of Behavioral ScienceRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
n-Acetylcysteine
Placebo
Subjects will receive 0.6 g oral n-acetylcysteine 4 times per day.
Subjects will receive oral placebo 4 times per day.