Evaluating N-acetylcysteine as a Pharmacotherapy for Tobacco Use Disorder
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- Nicotine Dependence
- Sponsor
- Medical University of South Carolina
- Enrollment
- 114
- Locations
- 1
- Primary Endpoint
- Number of Participants With Biochemically-verified Abstinence From Smoking on Days 1-3 of the Protocol.
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Erin McClure
Assistant Professor
Medical University of South Carolina
Eligibility Criteria
Inclusion Criteria
- •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
Arms & Interventions
Placebo
Matched placebo will be given to half of the study participants.
Intervention: Placebo
N-Acetylcysteine (NAC)
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: N-acetylcysteine (NAC)
Outcomes
Primary Outcomes
Number of Participants With Biochemically-verified Abstinence From Smoking on Days 1-3 of the Protocol.
Time Frame: Days 1-3 of the study 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 Outcomes
- Days to Relapse to Smoking Among Abstinent Participants(Days 4-56 of the study protocol)
- Number of Participants With 7-day Point Prevalence Abstinence at the 8-week End-of-treatment Visit(Days 49-56)