N-Acetylcysteine for Smoking Cessation in Tobacco and Cannabis Co-Use

• Status: Recruiting
• Trial end date: 2023-08-25
• Target enrollment: 0
• Participant gender: All

Summary

Tobacco and cannabis co-use is a common and growing public health problem, especially in states that have legalized cannabis. There are no pharmacologic treatments for co-occurring tobacco and cannabis use. Co-use may make quitting either substance more difficult, given the synergistic effects of cannabis and nicotine on neurobiological systems that mediate reward and shared cues reinforcing co-use. N-acetylcysteine (NAC), an FDA-approved medication and over-the-counter supplement, has shown promise in animal studies and randomized controlled trials (RCTs) in reducing tobacco and cannabis craving and use.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ellen Herbst
• Collaborator: Tobacco Related Disease Research Program
• Treatments: Acetylcysteine; N-monoacetylcystine

Criteria

Inclusion Criteria:

Participants will be male and female daily cigarette smokers ages 18 and over who: 1) endorse the use of smoked cannabis and have positive urine THC at Week 0; 2) meet criteria for TUD and CUD in the past 12 months per DSM-5, assessed by the Mini International Neuropsychiatric Interview140-141 (MINI); and 3) consent to receive interventions to stop smoking cigarettes and using cannabis. Although co-users can use tobacco and cannabis simultaneously (i.e. in "spliffs") and other forms of nicotine and tobacco, participants must smoke combustible cigarettes that are not mixed with cannabis on a daily basis to participate. Women of childbearing potential (ages 18-55) must have a negative urine pregnancy test at the time of screening.

Exclusion Criteria:

1) Psychotic disorders, bipolar disorder, neurocognitive disorder, or other psychiatric or medical conditions judged by the PI to be unstable in the past 30 days, based on MINI. 2) Concurrent participation in another addiction treatment study or pharmacological study. 3) Females who are pregnant or lactating. 4) Non-study NAC use at enrollment or at any time during the study period. 5) Use of medications for TUD (NRT, bupropion, or varenicline) at enrollment or at any time during the study period. 6) A suicide attempt or suicidal ideation with intent in the 30 days prior to enrollment.