N-acetylcysteine for Tobacco Use Disorder
Primary Purpose
Nicotine Dependence, Smoking
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
N-acetylcysteine (NAC)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Nicotine Dependence focused on measuring nicotine, tobacco, smoking, cessation, N-acetylcysteine, NAC, pharmacotherapy, relapse, tobacco use disorder
Eligibility Criteria
Inclusion Criteria:
- Age 18-65
- Daily smoker for ≥6 months, smoking approximately ≥5 cigarettes per day on average in the past month or must meet the criteria for nicotine dependence
- Be interested in quitting smoking (defined as a 2 or above on a 10-point Likert scale assessing readiness and interest in quitting (1=not at all ready/interested, 10=extremely ready/interested)
- Willing to engage in a 3-day quit attempt as part of study procedures
- Willing to abstain from cannabis use during study procedures (since inhaled cannabis will affect breath carbon monoxide readings).
- If female, agreement to use birth control (any form) to avoid pregnancy during study procedures
Exclusion Criteria:
- Any serious or unstable medical/psychiatric disorder (including severe substance use disorders, other than tobacco use disorder) in the past month that may interfere with study performance based on PI judgment
- Current pregnancy or breastfeeding
- Current use of medications with smoking cessation efficacy
- Known hypersensitivity to NAC
- Use of carbamazepine or nitroglycerin (or any other medication deemed to be hazardous if taken with NAC) within 14 days of study participation
Sites / Locations
- Medical University of South Carolina
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo
N-Acetylcysteine (NAC)
Arm Description
Matched placebo will be given to half of the study participants.
NAC will be given to half of the study participants. The dose of NAC will be 2400 mg per day (1200 mg taken twice per day as two 600 mg capsules)
Outcomes
Primary Outcome Measures
Number of Participants With Biochemically-verified Abstinence From Smoking on Days 1-3 of the Protocol.
Abstinence will be measured through biochemical verification via breath carbon monoxide. Abstinence is defined as a 75% reduction in carbon monoxide values (parts per million) from smoking baseline levels.
Secondary Outcome Measures
Days to Relapse to Smoking Among Abstinent Participants
Relapse to smoking will be measured through carbon monoxide-verified relapse at weekly study visits among those who abstained during the 3-day quit attempt. Relapse (return to smoking) will be defined as carbon monoxide values (in parts per million) that do not meet abstinence criteria (i.e., 75% reduction from baseline smoking levels).
Number of Participants With 7-day Point Prevalence Abstinence at the 8-week End-of-treatment Visit
Seven day point prevalence abstinence will be measured through biochemical verification via breath carbon monoxide and urinary cotinine analysis. Abstinence is defined as a 75% reduction in carbon monoxide values (parts per million) from smoking baseline levels and a negative urine cotinine measure (<80 ng/mL).
Full Information
NCT ID
NCT02737358
First Posted
March 14, 2016
Last Updated
July 31, 2020
Sponsor
Medical University of South Carolina
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT02737358
Brief Title
N-acetylcysteine for Tobacco Use Disorder
Official Title
Evaluating N-acetylcysteine as a Pharmacotherapy for Tobacco Use Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
August 30, 2016 (Actual)
Primary Completion Date
August 1, 2019 (Actual)
Study Completion Date
October 10, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess the effects of administering N-Acetylcysteine (NAC) to assist in initial cessation and/or relapse prevention in adult cigarette smokers.
Detailed Description
The aim of this study is to assess the effects of N-acetylcysteine (NAC) on initial cessation and relapse prevention in adult cigarette smokers. Specifically, this study has the following aims: Aim 1) Examine the efficacy of NAC, compared to placebo, in helping smokers achieve three days of continuous abstinence; Aim 2) Among those who maintain initial 3-day abstinence, examine the time to relapse over the 8-week intervention between NAC and placebo groups; Aim 3) Assess 7-day point prevalence abstinence at the 8-week end-of-treatment study visit in order to obtain effect sizes and estimates of variability to power a randomized clinical trial.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence, Smoking
Keywords
nicotine, tobacco, smoking, cessation, N-acetylcysteine, NAC, pharmacotherapy, relapse, tobacco use disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
114 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matched placebo will be given to half of the study participants.
Arm Title
N-Acetylcysteine (NAC)
Arm Type
Active Comparator
Arm Description
NAC will be given to half of the study participants. The dose of NAC will be 2400 mg per day (1200 mg taken twice per day as two 600 mg capsules)
Intervention Type
Drug
Intervention Name(s)
N-acetylcysteine (NAC)
Other Intervention Name(s)
NAC
Intervention Description
NAC or matched placebo will be given to study participants for 8 weeks.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Matched placebo (2 capsules taken in the morning and evening) will be taken by study participants for eight weeks. All participants will receive brief smoking cessation counseling and support.
Primary Outcome Measure Information:
Title
Number of Participants With Biochemically-verified Abstinence From Smoking on Days 1-3 of the Protocol.
Description
Abstinence will be measured through biochemical verification via breath carbon monoxide. Abstinence is defined as a 75% reduction in carbon monoxide values (parts per million) from smoking baseline levels.
Time Frame
Days 1-3 of the study protocol
Secondary Outcome Measure Information:
Title
Days to Relapse to Smoking Among Abstinent Participants
Description
Relapse to smoking will be measured through carbon monoxide-verified relapse at weekly study visits among those who abstained during the 3-day quit attempt. Relapse (return to smoking) will be defined as carbon monoxide values (in parts per million) that do not meet abstinence criteria (i.e., 75% reduction from baseline smoking levels).
Time Frame
Days 4-56 of the study protocol
Title
Number of Participants With 7-day Point Prevalence Abstinence at the 8-week End-of-treatment Visit
Description
Seven day point prevalence abstinence will be measured through biochemical verification via breath carbon monoxide and urinary cotinine analysis. Abstinence is defined as a 75% reduction in carbon monoxide values (parts per million) from smoking baseline levels and a negative urine cotinine measure (<80 ng/mL).
Time Frame
Days 49-56
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 18-65
Daily smoker for ≥6 months, smoking approximately ≥5 cigarettes per day on average in the past month or must meet the criteria for nicotine dependence
Be interested in quitting smoking (defined as a 2 or above on a 10-point Likert scale assessing readiness and interest in quitting (1=not at all ready/interested, 10=extremely ready/interested)
Willing to engage in a 3-day quit attempt as part of study procedures
Willing to abstain from cannabis use during study procedures (since inhaled cannabis will affect breath carbon monoxide readings).
If female, agreement to use birth control (any form) to avoid pregnancy during study procedures
Exclusion Criteria:
Any serious or unstable medical/psychiatric disorder (including severe substance use disorders, other than tobacco use disorder) in the past month that may interfere with study performance based on PI judgment
Current pregnancy or breastfeeding
Current use of medications with smoking cessation efficacy
Known hypersensitivity to NAC
Use of carbamazepine or nitroglycerin (or any other medication deemed to be hazardous if taken with NAC) within 14 days of study participation
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
29513609
Citation
Tomko RL, Gray KM, Oppenheimer SR, Wahlquist AE, McClure EA. Using REDCap for ambulatory assessment: Implementation in a clinical trial for smoking cessation to augment in-person data collection. Am J Drug Alcohol Abuse. 2019;45(1):26-41. doi: 10.1080/00952990.2018.1437445. Epub 2018 Mar 7.
Results Reference
derived
Learn more about this trial
N-acetylcysteine for Tobacco Use Disorder
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