N-acetylcysteine for Tobacco Use Disorder
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02737358|
Recruitment Status : Recruiting
First Posted : April 13, 2016
Last Update Posted : January 31, 2018
|Condition or disease||Intervention/treatment||Phase|
|Nicotine Dependence Smoking||Drug: N-acetylcysteine (NAC) Other: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||110 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Evaluating N-acetylcysteine as a Pharmacotherapy for Tobacco Use Disorder|
|Study Start Date :||August 30, 2016|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||August 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
|Contact: Erin A McClure, PhDfirstname.lastname@example.org|
|Contact: Lori Ann A Ueberrothemail@example.com|
|United States, South Carolina|
|Medical University of South Carolina||Recruiting|
|Charleston, South Carolina, United States, 29425|
|Contact: Robert H Peiffer firstname.lastname@example.org|