Clinical trial NCT02737358: N-acetylcysteine for Tobacco Use Disorder
Official title: Evaluating N-acetylcysteine as a Pharmacotherapy for Tobacco Use Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Nicotine Dependence
Smoking
Keywords: nicotine
tobacco
smoking
cessation
N-acetylcysteine
NAC
pharmacotherapy
relapse
tobacco use disorder
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2016-04-13
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Age 18-65
2. 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
3. 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)
4. Willing to engage in a 3-day quit attempt as part of study procedures
5. Willing to abstain from cannabis use during study procedures (since inhaled cannabis will affect breath carbon monoxide readings).
6. If female, agreement to use birth control (any form) to avoid pregnancy during study procedures

Exclusion Criteria:

1. 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
2. Current pregnancy or breastfeeding
3. Current use of medications with smoking cessation efficacy
4. Known hypersensitivity to NAC
5. Use of carbamazepine or nitroglycerin (or any other medication deemed to be hazardous if taken with NAC) within 14 days of study participation

Primary outcomes:
measure: Number of Participants With Biochemically-verified Abstinence From Smoking on Days 1-3 of the Protocol.
timeFrame: Days 1-3 of the study protocol
Secondary outcomes:
measure: Days to Relapse to Smoking Among Abstinent Participants
timeFrame: Days 4-56 of the study protocol
measure: Number of Participants With 7-day Point Prevalence Abstinence at the 8-week End-of-treatment Visit
timeFrame: Days 49-56
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References:
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.