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
Headshot 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 in dual users of tobacco and cannabis. Sixty adult regular cigarette smokers who 1) have smoked 5 cigarettes per day in 15 of the past 30 days, or an average of 2.5 cigarettes per day for the past 30 days and 2) use cannabis regularly and 3) 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, and craving. Exploratory aims include examination of changes in neurocognition with NAC and their potential mediational effects on cigarette and cannabis use outcomes. NAC SUB-STUDY: Because of the significant clinical and economic burden imposed by tobacco and cannabis use, it is important to understand the mechanism underlying the progression of tobacco (TUD) and cannabis use disorders (CUD) and any potential treatments. TUD and CUD are associated with elevated oxidative stress and chronic inflammation. It has been suggested that patients dependent on these substances have dysregulated markers of oxidation and inflammation, including gluthathione, erythrocyte sedimentation rate (ESR), C-Reactive protein (CRP), Interleukin-6 (IL-6). In this sub-study, baseline levels of commonly utilized serum markers of oxidation status and inflammation will be measured in 20 adults recruited under the main study, with the option of being a part of the sub-study who also demonstrate concurrent TUD and CUD. The correlation will be determined between changes in serum markers of oxidative stress and magnitude of use of cigarettes and cannabis. If successful, the investigator will establish regulatory patterns of oxidative stress and inflammation in co-occurring TUD and CUD for the first time, and will implicate oxidative stress and inflammation as playing key roles in the progression and severity of co-occurring TUD and CUD.

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 smokers ages 18 and over who: 1) have smoked 5 cigarettes per day in 15 of the past 30 days, or an average of 2.5 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; 3) meet criteria for TUD in the past 12 months per DSM-5, assessed by the Mini International Neuropsychiatric Interview140-141 (MINI), medical record review, and clinical assessment; and 4) 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. 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).

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) 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. 7) Non-residents of California or Veterans in another state who are not enrolled in VA healthcare.

Location

  • San Francisco Veterans Affairs Medical Center accepting new patients
    San Francisco California 94121 United States

Lead Scientist at UCSF

  • Ellen Herbst, MD
    Professor, Psychiatry, School of Medicine. Authored (or co-authored) 17 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Ellen Herbst
Links
Provides Link to NAC Study (in development)
ID
NCT04627922
Phase
Phase 4 research study
Study Type
Interventional
Participants
Expecting 60 study participants
Last Updated