Effects of N-Acetylcysteine on Cocaine and Opioid Use Disorders

Glutamatergic Mechanisms in Opioid and Cocaine Co-Use

This study is testing if a supplement called N-acetylcysteine can help people aged 18 to 55 who are dealing with both opioid and cocaine use disorders by reducing cravings during withdrawal.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: University of Kentucky (Academic / other)
• Locations: 2 sites (Lexington, Kentucky and 1 other locations)
• Trial ID: NCT05610072 on ClinicalTrials.gov

What this trial studies

This study investigates how chronic opioid use affects cocaine consumption during withdrawal and whether N-acetylcysteine (NAC) can help regulate brain glutamate levels to reduce cravings for both substances. Participants aged 18 to 55 with opioid and cocaine use disorders will be maintained on hydromorphone and randomly assigned to receive either NAC or a placebo. The study will assess the reinforcing effects of cocaine through hypothetical purchasing tasks during both opioid maintenance and withdrawal phases. The goal is to understand the interaction between opioid dependence and cocaine use and the potential therapeutic role of NAC.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 55 who are physically dependent on short-acting opioids and have a history of cocaine use disorder.

Not a fit: Patients who are actively seeking treatment for their substance use or have significant health issues unrelated to their substance use disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies for individuals struggling with both opioid and cocaine use disorders.

How similar studies have performed: While the specific combination of NAC and opioid dependence is novel, previous studies have shown promise in using NAC for substance use disorders.

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.

Where this trial is running

Lexington, Kentucky and 1 other locations

• University of Kentucky Laboratory of Human Behavioral Pharmacology — Lexington, Kentucky, United States (Recruiting)
• University of Kentucky Department of Behavioral Science — Lexington, Kentucky, United States (Recruiting)

Study contacts

• Principal investigator: William W Stoops — University of Kentucky
• Study coordinator: William W Stoops, PhD

Conditions Cocaine Use Disorder; Opioid Use Disorder