N-acetylcysteine for Tobacco Use Disorder

Smoking Clinical Trial

Official title:

Evaluating N-acetylcysteine as a Pharmacotherapy for Tobacco Use Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02737358
• Other study ID #: Pro 00052793
• Secondary ID: R34DA042228
• Status: Completed
• Phase: Phase 2
• Start date: August 30, 2016
• Est. completion date: October 10, 2019

Study information

• Verified date: July 2020
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: October 10, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Nicotine Dependence
• Smoking
• Tobacco Use Disorder

Intervention

Drug:
• N-acetylcysteine (NAC)
NAC or matched placebo will be given to study participants for 8 weeks.

Other:
• Placebo
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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Days 1-3 of the study protocol
Secondary	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).	Days 4-56 of the study protocol
Secondary	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).	Days 49-56