N-acetylcysteine for Tobacco Use Disorder

Medical University of South Carolina (MUSC)

Status and phase: Completed; Phase 2

Conditions: Nicotine Dependence; Smoking

Treatments: Drug: N-acetylcysteine (NAC); Other: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02737358

R34DA042228 (U.S. NIH Grant/Contract)

Pro 00052793

Details and patient eligibility

About

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.

Full 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.

Enrollment: 114 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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114 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Matched placebo will be given to half of the study participants.

Treatment:

Other: Placebo

N-Acetylcysteine (NAC)

Active Comparator group

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)

Treatment:

Drug: N-acetylcysteine (NAC)