Varenicline for Smoking Reduction in Veterans Not Ready To Quit

VA Office of Research and Development

Status and phase: Begins enrollment in 1 month; Phase 4

Conditions: Tobacco Dependence; Cigarette Smoking; Veterans; Tobacco Use Disorder

Treatments: Drug: Motivation-Phase Varenicline; Behavioral: Cessation-Phase Counseling; Drug: Motivation-Phase Nicotine Mini-Lozenge; Drug: Cessation-Phase Combination Nicotine Replacement Therapy (NRT); Behavioral: Motivation-Phase Counseling; Drug: Cessation-Phase Varenicline

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT06966362

NURA-007-24F

Details and patient eligibility

About

In order to reduce the prevalence of cigarette smoking among Veterans, it is vital that healthcare providers 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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 2 patient groups

Motivation-Phase Varenicline

Experimental group

Description:

Varenicline use during pre-quit phase of smoking treatment for participants who are interested in cutting down on their smoking.

Treatment:

Drug: Cessation-Phase Varenicline

Behavioral: Motivation-Phase Counseling

Behavioral: Cessation-Phase Counseling

Drug: Motivation-Phase Varenicline

Motivation-Phase Nicotine Mini-Lozenge

Active Comparator group

Description:

NRT mini-lozenge use during pre-quit phase of smoking treatment for participants who are interested in cutting down on their smoking.

Treatment:

Behavioral: Motivation-Phase Counseling

Drug: Cessation-Phase Combination Nicotine Replacement Therapy (NRT)

Behavioral: Cessation-Phase Counseling

Drug: Motivation-Phase Nicotine Mini-Lozenge