Smoking Clinical Trial
Official title:
Evaluating N-acetylcysteine as a Pharmacotherapy for Tobacco Use Disorder
Verified date | July 2020 |
Source | Medical University of South Carolina |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Medical University of South Carolina | Charleston | South Carolina |
Lead Sponsor | Collaborator |
---|---|
Medical University of South Carolina | National Institute on Drug Abuse (NIDA) |
United States,
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 |
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