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Mucolytic Agent

N-Acetylcysteine for Substance Use Disorder (NAC_CUD-TUD Trial)

Phase 4
Recruiting
Led By Ellen Herbst, MD
Research Sponsored by Ellen Herbst
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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).
Individuals who have been prescribed bupropion for depression, not smoking cessation, are eligible to participate in this study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights

NAC_CUD-TUD Trial Summary

This trial will test whether NAC can reduce the amount of tobacco and cannabis people use.

Who is the study for?
This trial is for adult smokers in California who smoke cigarettes daily and have used cannabis in the last 30 days. They must want to quit smoking, not be using other cessation drugs or participating in another cessation study, and can't have certain psychiatric conditions or be pregnant.Check my eligibility
What is being tested?
The trial tests N-Acetylcysteine (NAC) against a placebo while participants also receive Cognitive Behavioral Therapy (CBT). It aims to see if NAC helps reduce cravings and use of both tobacco and cannabis compared to just CBT alone.See study design
What are the potential side effects?
While not specified here, common side effects of NAC may include nausea, vomiting, rash, and headache. Side effects from CBT are rare but can include discomfort from discussing past experiences related to substance use.

NAC_CUD-TUD Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am taking bupropion for depression, not to quit smoking.
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I have been diagnosed with tobacco use disorder in the last year.
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I have used cannabis in the last 30 days and tested positive for THC.
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I am a smoker, 18 or older, and have smoked regularly for the past month.
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I am of childbearing age and my pregnancy test is negative.

NAC_CUD-TUD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Percentage of Participants with Point Prevalent Abstinence
Change in Scores on the Beck Anxiety Inventory (BAI)
Change in Scores on the Beck Depression Inventory (BDI)
+14 more

Side effects data

From 2024 Phase 2 trial • 13 Patients • NCT03499249
62%
GGT 400 IU/L >pre-KP value
46%
AST 400 IU/L >pre-KP value
31%
Loss of an IV
23%
Emesis with feeds
15%
Febrile illness
15%
Conjugated bilirubin 3 mg/dL >pre-KP value
8%
Tachycardia
8%
ALT 700 IU/L >pre-KP value
8%
INR >2.0
8%
Total bilirubin 5 mg/dL >pre-KP value
100%
80%
60%
40%
20%
0%
Study treatment Arm
N-Acetylcysteine Treatment

NAC_CUD-TUD Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: N-acetyl cysteine (NAC) & cognitive behavioral therapyExperimental Treatment2 Interventions
N-acetyl cysteine (NAC) & cognitive behavioral therapy experimental arm consists of 30 regular cigarette smokers and cannabis users with current TUD, who will be randomized to receive N-acetyl cysteine 3600 mg per day over 8 weeks to experimental arm. Participants will also receive weekly cognitive behavioral therapy for substance use disorders targeting TUD and cannabis use.
Group II: Placebo Comparator: Placebo & cognitive behavioral therapyPlacebo Group2 Interventions
Placebo comparator & cognitive behavioral therapy arm consists of 30 regular cigarette smokers and cannabis users with current TUD, who will be randomized to receive placebo over 8 weeks. Participants will also receive weekly cognitive behavioral therapy for substance use disorders targeting TUD and cannabis use.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
N-Acetyl cysteine
2022
Completed Phase 4
~190
Cognitive behavioral therapy (CBT)
2002
Completed Phase 3
~2020

Find a Location

Who is running the clinical trial?

Ellen HerbstLead Sponsor
Tobacco Related Disease Research ProgramOTHER
25 Previous Clinical Trials
20,558 Total Patients Enrolled
7 Trials studying Tobacco Use Disorder
949 Patients Enrolled for Tobacco Use Disorder
Brianna GarciaStudy DirectorSan Francisco Veterans Affairs Medical Center

Media Library

N-Acetyl cysteine (Mucolytic Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04627922 — Phase 4
Tobacco Use Disorder Research Study Groups: Placebo Comparator: Placebo & cognitive behavioral therapy, N-acetyl cysteine (NAC) & cognitive behavioral therapy
Tobacco Use Disorder Clinical Trial 2023: N-Acetyl cysteine Highlights & Side Effects. Trial Name: NCT04627922 — Phase 4
N-Acetyl cysteine (Mucolytic Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04627922 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there current openings for this clinical experiment?

"Affirmative, the information available on clinicaltrials.gov conveys that this trial is actively recruiting volunteers. This research project was initially published 8/25/2021 and had its most recent update 9/26/2022. Sixty participants are desired from a single site."

Answered by AI

What is the current total of participants enrolled in this medical experiment?

"Affirmative. According to information found on clinicaltrials.gov, this study is presently seeking participants with the initial post dated August 25th 2021 and last revised September 26th 2022. The trial will require 60 individuals from a single medical centre for completion."

Answered by AI

What level of safety has been observed with the therapeutic use of N-Acetyl cysteine?

"Because N-Acetyl cysteine has already been approved, its safety rating is a 3 according to our assessment."

Answered by AI

Who else is applying?

What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
San Francisco Veterans Affairs Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

How responsive is this trial?

Typically responds via
Email
Recent research and studies
~7 spots leftby Aug 2024