Clinical trial NCT06966362: Varenicline for Smoking Reduction in Veterans Not Ready To Quit
Official title: Varenicline for Smoking Reduction in Veterans Unwilling to Quit
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Veterans
Tobacco Use Disorder
Cigarette Smoking
Tobacco Dependence
Keywords: Varenicline
Tobacco use disorder
Veterans
Quit attempts
Cigarette smoking
Motivation phase treatment
Nicotine replacement therapy
Smoking reduction
Smoking abstinence
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2025-05-11
Enrollment: 400
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to one of two 12-week Motivation-phase treatment groups: (1) varenicline, or (2) NRT (2 mg mini-lozenges).
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Biochemically confirmed 7-day point-prevalence abstinence
timeFrame: 12 months post-study entry
Secondary outcomes:
measure: 7-day point prevalence abstinence
timeFrame: 6 months post-study entry
measure: Making a quit attempt lasting 24 hours
timeFrame: 6 and 12 months post-study entry
measure: Cessation treatment entry
timeFrame: 6 months post-study entry
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego, CA
state: California
city: Minneapolis
country: United States
facility: Minneapolis VA Health Care System, Minneapolis, MN
state: Minnesota
city: Durham
country: United States
facility: Durham VA Medical Center, Durham, NC
state: North Carolina
city: Madison
country: United States
facility: William S. Middleton Memorial Veterans Hospital, Madison, WI
state: Wisconsin
Study officials:
affiliation: William S. Middleton Memorial Veterans Hospital, Madison, WI
name: Jessica Megan Cook, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: VA San Diego Healthcare System, San Diego, CA
name: Neal M Doran, PhD
role: PRINCIPAL_INVESTIGATOR
References: