Varenicline for Smoking Reduction in Veterans Not Ready To Quit
- Conditions
- Tobacco Use DisorderCigarette SmokingTobacco DependenceVeterans
- Interventions
- Drug: Motivation-Phase Nicotine Mini-LozengeDrug: Motivation-Phase VareniclineDrug: Cessation-Phase Combination Nicotine Replacement Therapy (NRT)Drug: Cessation-Phase VareniclineBehavioral: Motivation-Phase CounselingBehavioral: Cessation-Phase Counseling
- Registration Number
- NCT06966362
- Lead Sponsor
- VA Office of Research and Development
- Brief Summary
In order to reduce the prevalence of cigarette smoking among Veterans, it is vital that the investigators offer effective tobacco treatment to all Veterans who smoke, including those not ready to make a quit attempt. Smoking treatments currently available to Veterans who are not ready to quit are only weakly effective. This project will generate new knowledge about the effectiveness of a promising varenicline-based intervention designed to increase quit attempts and long-term abstinence in Veterans who are initially not ready to quit. This project has great potential to engage Veterans not ready to quit smoking in treatment that increases quit attempts and quitting success, thereby reducing morbidity and mortality caused by smoking in Veterans.
- Detailed Description
Evidence-based smoking cessation treatments can double smoking abstinence rates, yet these treatments are underused by the millions of Veterans who smoke. One reason for this is that the great majority of people who smoke are not ready to make a quit attempt when cessation treatment is offered (70-90%). An important public health goal is to increase engagement of people not ready to quit smoking in highly effective treatment that prepares them to make quit attempts and ultimately achieve abstinence (i.e., Motivation-phase treatment; MPT). MPT typically combines smoking reduction counseling with nicotine replacement therapy (NRT). Although offering NRT Motivation-phase treatment (NRT MPT) in healthcare settings increases the reach of tobacco treatment, such interventions only weakly affect long-term abstinence. It is vital that the investigators develop more effective MPTs that increase quit attempts and quitting success in people not ready to quit. Varenicline, the most effective single agent smoking cessation pharmacotherapy, holds great promise as an intervention for people who are not ready to make a quit attempt. The investigators propose that MPT will be markedly more effective if it involves the use of varenicline (vs. NRT) because it will more effectively reduce smoking reward, affective withdrawal, and tonic craving. Initial evidence suggests that varenicline increases quitting motivation in those not ready to quit, but the extant studies have not 1) directly evaluated varenicline effectiveness in this population and 2) compared varenicline MPT with NRT MPT, the current standard treatment for those not ready to make a quit attempt. The goal of this study is to evaluate whether varenicline MPT is especially effective and cost-effective relative to NRT MPT, in Veterans who are willing to reduce but not quit smoking. This study will compare the use of varenicline MPT vs. NRT MPT on: biochemically verified point-prevalence abstinence at 1 year (primary outcome), quit attempts, and cessation treatment use.
This study is a 2-group randomized controlled trial that will enroll 400 adults from three geographically diverse VA hospitals who smoke 5 cigarettes/day and do not want to quit smoking in the next 30 days but are willing to cut down. Participants will be randomized to one of two 12-week MPT groups: (1) varenicline, or (2) NRT (2 mg mini-lozenges). All participants will receive 5 phone counseling sessions focused on smoking reduction during the 12-week MPT. Any participants who decide to try quitting will receive smoking cessation treatment involving continued use of their assigned study medication and cessation counseling.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 400
- Report smoking an average of 5 or more cigarettes daily for the previous 6 months
- Not ready to set a quit date in the next 30 days but willing to cut down on their smoking
- Able to read, write, and speak English
- Be medically eligible to use study medications (NRT or varenicline)
- If female, use an approved method of birth control while using study medication
- Be at least 21 years old
- Be a Veteran
- Unable to give informed, voluntary consent to participate
- Current use of any pharmacotherapy for smoking cessation
- Use of non-cigarette tobacco products as primary form of tobacco use
- Incarceration
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Motivation-Phase Nicotine Mini-Lozenge Cessation-Phase Combination Nicotine Replacement Therapy (NRT) NRT mini-lozenge use during pre-quit phase of smoking treatment for participants who are interested in cutting down on their smoking. Motivation-Phase Nicotine Mini-Lozenge Motivation-Phase Counseling NRT mini-lozenge use during pre-quit phase of smoking treatment for participants who are interested in cutting down on their smoking. Motivation-Phase Nicotine Mini-Lozenge Cessation-Phase Counseling NRT mini-lozenge use during pre-quit phase of smoking treatment for participants who are interested in cutting down on their smoking. Motivation-Phase Nicotine Mini-Lozenge Motivation-Phase Nicotine Mini-Lozenge NRT mini-lozenge use during pre-quit phase of smoking treatment for participants who are interested in cutting down on their smoking. Motivation-Phase Varenicline Motivation-Phase Varenicline Varenicline use during pre-quit phase of smoking treatment for participants who are interested in cutting down on their smoking. Motivation-Phase Varenicline Cessation-Phase Varenicline Varenicline use during pre-quit phase of smoking treatment for participants who are interested in cutting down on their smoking. Motivation-Phase Varenicline Motivation-Phase Counseling Varenicline use during pre-quit phase of smoking treatment for participants who are interested in cutting down on their smoking. Motivation-Phase Varenicline Cessation-Phase Counseling Varenicline use during pre-quit phase of smoking treatment for participants who are interested in cutting down on their smoking.
- Primary Outcome Measures
Name Time Method Biochemically confirmed 7-day point-prevalence abstinence 12 months post-study entry Participants who report 7-day point-prevalence abstinence from cigarettes at the 12 month follow-up will mailed a saliva collection kit that will test cotinine and anabasine to validate self-reported abstinence from combusted tobacco.
- Secondary Outcome Measures
Name Time Method 7-day point prevalence abstinence 6 months post-study entry Participants who report 7-day point-prevalence abstinence from cigarettes at the 6 month follow-up will mailed a saliva collection kit that will test cotinine and anabasine to validate self-reported abstinence from combusted tobacco.
Making a quit attempt lasting 24 hours 6 and 12 months post-study entry Making a quit attempt lasting at least 24 hours by 6 and 12 months; coded as binary (0 or 1).
Cessation treatment entry 6 months post-study entry Entering cessation treatment; coded as binary (0 or 1)
Trial Locations
- Locations (4)
VA San Diego Healthcare System, San Diego, CA
🇺🇸San Diego, California, United States
Minneapolis VA Health Care System, Minneapolis, MN
🇺🇸Minneapolis, Minnesota, United States
Durham VA Medical Center, Durham, NC
🇺🇸Durham, North Carolina, United States
William S. Middleton Memorial Veterans Hospital, Madison, WI
🇺🇸Madison, Wisconsin, United States