N-Acetylcysteine for Smoking Cessation in Tobacco and Cannabis Co-Use (NCT04627922) | Clinical Trial Compass
CompletedPhase 4
N-Acetylcysteine for Smoking Cessation in Tobacco and Cannabis Co-Use
United States59 participantsStarted 2021-08-25
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Participants will be male and female smokers ages 18 and over who: 1) have smoked 2 cigarettes per day in 15 of the past 30 days, or an average of 1 cigarettes per day for the past 30 days; 2) endorse the use of cannabis within the past 30 days, reported by TLFB, and have positive urine THC at Week 0 or up to 30 days prior; 3) meet criteria for TUD in the past 12 months per DSM-5, assessed by medical record review and clinical assessment; and 4) consent to receive interventions to stop smoking cigarettes and reducing cannabis use. 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. Individuals of childbearing potential (ages 18-55) must have a negative urine pregnancy test at the time of screening. Individuals who have been prescribed bupropion for depression, not smoking cessation, are eligible to participate in this study. All participants must be California residents (Veterans enrolled in VA healthcare in another state are eligible).
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 screening results and/or medical record review. 2) Concurrent participation in another pharmacological tobacco cessation study. 3) Individuals who ar…
What they're measuring
1
Change in the mean days of cannabis use over time
Timeframe: Up to Week 12
2
Change in the mean number of cigarettes used over time
Timeframe: Up to Week 12
3
Change in the mean number of days of cigarette use over time
Timeframe: Up to Week 12
4
Percentage of participants with biochemically verified, point prevalent abstinence at week 8
Timeframe: At Week 8
5
Percentage of participants with Biochemically verified point prevalent abstinence at week 12
Timeframe: At Week 12
6
Change in Scores on the Fagerstrom Test for Nicotine Dependence (FTND) over time
Timeframe: Up to 12 weeks
7
Change in Scores on the Questionnaire on Smoking Urges (QSU-Brief): Desire to smoke over time
Timeframe: Up to 12 weeks
8
Change in Scores on the Questionnaire on Smoking Urges (QSU-Brief): Nicotine withdrawal over time