N-Acetylcysteine for Smoking Cessation in Tobacco and Cannabis Co-Use (NAC_CUD-TUD)

  • STATUS
    Recruiting
  • End date
    Aug 25, 2023
  • participants needed
    60
  • sponsor
    Ellen Herbst
Updated on 17 June 2022
substance use
behavior therapy
cannabis use
behavioral therapy
bupropion
tobacco smoke
smoke tobacco
nicotine product
smoking cessation therapy
Accepts healthy volunteers

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.

Description

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.

Details
Condition Cannabis Use, Tobacco Use Disorder, Drug Use Disorder
Treatment Placebo Comparator, N-Acetyl Cysteine, Cognitive behavioral therapy (CBT)
Clinical Study IdentifierNCT04627922
SponsorEllen Herbst
Last Modified on17 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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)

Exclusion Criteria

) 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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note