Health TrialsbyHealthPanel

Varenicline for Smoking Reduction in Veterans Not Ready To Quit

ConditionsVeteransTobacco Use DisorderCigarette SmokingTobacco Dependence
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age21+
SponsorVA Office of Research and Development

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 (nicotine replacement therapy (NRT) or varenicline)

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Motivation-Phase Varenicline

    Drug

    Varenicline reduction dosing will start when participants initiate Motivation-phase treatment: 0.5 milligrams (mg) once daily for 3 days, increasing to 0.5mg twice daily for days 4 to 7, and then to the maintenance dose of 1mg twice daily for the duration of the 12-week reduction regimen.

  • Motivation-Phase Nicotine Mini-Lozenge

    Drug

    NRT mini-lozenge reduction dosing will start when participants initiate Motivation-phase treatment: 2-milligrams (mg) mini-lozenges in place of cigarettes (5-15/day).

  • Cessation-Phase Combination Nicotine Replacement Therapy (NRT)

    Drug

    Combination NRT (nicotine patch + nicotine mini-lozenge) cessation dosing will begin on the target quit day: if smoking \>10 cigarettes/day = 8 weeks of 21-milligrams (mg), 2 weeks of 14-mg, and 2 weeks of 7-mg nicotine patches; if smoking 10 cigarettes/day = 10 weeks of 14-mg and 2 weeks of 7-mg nicotine patches. All participants will receive 2 or 4 mg mini-lozenge for the 12-week cessation period (9/day, 1 piece every 1-2/hours).

  • Cessation-Phase Varenicline

    Drug

    Varenicline cessation dosing will start one week prior to their target quit date (TQD): 0.5 milligrams (mg) once daily for 3 days, increasing to 0.5mg twice daily for days 4 to 7, and then to the maintenance dose of 1mg twice daily for the remainder of the 12-week cessation regimen.

  • Motivation-Phase Counseling

    Behavioral

    All participants receive motivation-phase counseling. Motivation-phase counseling involves 5, 10-15-minute counseling calls. The counselor will work with participants on smoking control skills selected by the participant, such as avoidance of smoking cues, reducing smoking heaviness/contexts, developing urge coping skills, or finding support from friends and family. Counseling will emphasize setting realistic and achievable smoking control goals. Counseling will also emphasize competence and self-efficacy, which will be linked to success in smoking control.

  • Cessation-Phase Counseling

    Behavioral

    All participants who enter cessation treatment will be offered 4, 10-15-minute counseling calls. The first counseling session involves pre-quit preparation, and can occur any time before the target quit day. The other 3 counseling calls will be scheduled for 1 day, 1 week, and 4 weeks after the target quit date. Cessation counseling will be based on treatment guidelines and will review instructions for when to start cessation medication, the timing of the quit day (relative to medication start), and medication adherence. Counseling will involve problem solving and skill development.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Motivation-Phase VareniclineExperimental treatment 4 interventions
Group B: Motivation-Phase Nicotine Mini-LozengeActive comparator 4 interventions

Trial outcomes

Primary outcomes

1

7-day point prevalence abstinence

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.

Time frame
6 months post-study entry

Secondary outcomes

1

Making a quit attempt lasting 24 hours

Making a quit attempt lasting at least 24 hours by 6 and 12 months; coded as binary (0 or 1).

Time frame
6 and 12 months post-study entry
2

Cessation treatment entry

Entering cessation treatment; coded as binary (0 or 1)

Time frame
6 months post-study entry
3

Biochemically confirmed 7-day point-prevalence abstinence

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.

Time frame
12 months post-study entry

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

VA Office of Research and Development

Lead sponsor

Source ClinicalTrials.gov
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