Summary

Eligibility
for people ages 18 years and up (full criteria)
Healthy Volunteers
healthy people welcome
Location
at San Francisco, California
Dates
study started
estimated completion
Principal Investigator
by Ellen Herbst, MD
Photo of Ellen Herbst
Ellen Herbst

Description

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.

Official Title

N-Acetylcysteine for Smoking Cessation in Tobacco and Cannabis Co-Use: A Randomized Controlled Trial

Details

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. NAC's efficacy in treating addiction may be attributable to its central nervous system effects in reducing excessive glutamatergic activity, oxidative stress, and inflammation. NAC has been shown to improve cognition and reduce impulsivity, which in turn may strengthen inhibitory control when presented with contextual cues. To date, no RCT has examined NAC for smoking cessation in the setting of tobacco-cannabis co-use. In a double-blind, placebo-controlled RCT, the investigators will examine a novel pharmacological treatment, NAC, for concurrent tobacco use disorder (TUD) and cannabis use disorder (CUD) in dual users of tobacco and cannabis. Sixty adult daily cigarette smokers who 1) use cannabis regularly and 2) consent to receive interventions to stop smoking cigarettes and using cannabis will be randomized to receive NAC 3600 mg per day or placebo over 8 weeks. Participants in both groups will receive 8 weekly cognitive behavioral therapy sessions addressing both tobacco and cannabis use. Outcomes will be assessed at Weeks 0, 4, 8, and 12. Primary aims are to determine NAC's efficacy in decreasing cigarette use, nicotine dependence levels, and craving; and cannabis use, CUD severity levels, and craving. Exploratory aims include examination of changes in neurocognition with NAC and their potential mediational effects on cigarette and cannabis use outcomes.

Keywords

Cannabis Use Tobacco Use Disorder Drug Use Disorder Tobacco Cannabis N-acetylcysteine NAC Disease Marijuana Abuse Substance-Related Disorders Acetylcysteine N-monoacetylcystine N-Acetyl cysteine Cognitive behavioral therapy (CBT) N-acetyl cysteine (NAC) & cognitive behavioral therapy

Eligibility

You can join if…

Open to people ages 18 years and up

  • Participants will be male and female daily cigarette smokers ages 18 and over who:
  • endorse use of smoked cannabis 15 or more of the past 30 days and have positive urine Tetrahydrocannabinol (THC) at Week 0;
  • meet criteria for Tobacco use disorder (TUD) and Cannabis use disorder (CUD) in the past 12 months per Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5), assessed by the Mini International Neuropsychiatric Interview (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. Female subjects 18-55 must have a negative urine pregnancy test at the time of screening.

You CAN'T join if...

  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. NAC use at the time of enrollment or at any time during the study period.
  5. Use of medications for TUD (NRT, bupropion, or varenicline) at the time of 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.

Location

  • San Francisco VA Medical Center
    San Francisco California 94121 United States

Lead Scientist at UCSF

  • Ellen Herbst, MD
    Professor, Psychiatry. Authored (or co-authored) 14 research publications.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Ellen Herbst
Links
Provides Link to NAC Study (in development)
ID
NCT04627922
Phase
Phase 4
Study Type
Interventional
Last Updated