Phase 2
Completed N=114
N-acetylcysteine for Tobacco Use Disorder
Source: ClinicalTrials.gov NCT02737358 ↗Enrolled (actual)
114
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcomePrimary: Number of Participants With Biochemically-verified Abstinence From Smoking on Days 1-3 of the Protocol. — 8; 6 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Biochemically-verified Abstinence From Smoking on Days 1-3 of the Protocol. |
8; 6 | — |
| SECONDARY Days to Relapse to Smoking Among Abstinent Participants |
17.0; 3.8 | — |
| SECONDARY Number of Participants With 7-day Point Prevalence Abstinence at the 8-week End-of-treatment Visit |
6; 4 | — |
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
Data sourced from ClinicalTrials.gov (NCT02737358). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.