Behavioral Effects of Drugs (Inpatient): 43 (Opioids, Cocaine, n-Acetylcysteine)

Launched by WILLIAM STOOPS · Nov 4, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how certain drugs, specifically n-acetylcysteine (NAC), might help people who are struggling with both opioid and cocaine use disorders. The researchers believe that using opioids can change brain chemicals in a way that makes it harder for individuals to resist cocaine, especially during withdrawal from opioids. By giving participants NAC, they hope to see if it can help balance these brain chemicals and reduce cravings for both opioids and cocaine.

To be eligible for this study, participants should be between 18 and 55 years old, have recently used both opioids and cocaine, and be physically dependent on short-acting opioids. They should not be currently seeking treatment for substance use. Participants will receive either NAC or a placebo (a non-active substance) while being monitored. They will also complete tasks that help researchers understand their cravings for cocaine during different stages of opioid use. The study aims to improve our understanding of how to better support individuals facing these challenges.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Between the ages of 18 and 55 years,
• • 2. Report recent use of opioids and cocaine and must not be seeking treatment for their drug use,
• • 3. Be physically dependent on short-acting opioids,
• • 4. 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
• • 5. Other than the diagnosis for opioid and cocaine use disorder at the time of the screening, subjects must be healthy,
• • 6. 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,
• • 7. No contraindications to magnetic resonance imagining (MRI; e.g., metallic objects in their body, BMI \> or = 40, claustrophobia) will be considered ineligible,
• • 8. 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,
• • 9. All study subjects will be judged by the medical staff to be psychiatrically and physically healthy.
• Exclusion Criteria:
• • 1. 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,
• • 2. 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,
• • 3. Subjects who report a positive first-degree family history of schizophrenia, serious cardiovascular disease, or seizure disorders will also be excluded from research participation.
• • 4. Subjects with contraindications to hydromorphone or n-acetylcysteine will not be eligible.