N-acetylcysteine for Tobacco Use Disorder
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|ClinicalTrials.gov Identifier: NCT02737358|
Recruitment Status : Completed
First Posted : April 13, 2016
Last Update Posted : November 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Nicotine Dependence Smoking||Drug: N-acetylcysteine (NAC) Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||114 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Evaluating N-acetylcysteine as a Pharmacotherapy for Tobacco Use Disorder|
|Actual Study Start Date :||August 30, 2016|
|Actual Primary Completion Date :||August 1, 2019|
|Actual Study Completion Date :||October 10, 2019|
Placebo Comparator: Placebo
Matched placebo will be given to half of the study participants.
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.
Active Comparator: N-Acetylcysteine (NAC)
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)
Drug: N-acetylcysteine (NAC)
NAC or matched placebo will be given to study participants for 8 weeks.
Other Name: NAC
- Biochemically-verified abstinence from smoking on Days 1-3 of the protocol. [ Time Frame: Days 1-3 of the study 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 to relapse to smoking [ Time Frame: Days 4-56 of the study protocol ]Relapse to smoking will be measured through carbon monoxide-verified relapse at weekly study visits. 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).
- 7-day point prevalence abstinence at the 8-week end-of-treatment visit [ Time Frame: Days 49-56 ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02737358
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|