400 Participants Needed

Varenicline for Smoking

Recruiting at 3 trial locations
JM
EG
Overseen ByElana G Brubaker, MSW BS
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: VA Office of Research and Development
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

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.

Research Team

JM

Jessica Megan Cook, PhD

Principal Investigator

William S. Middleton Memorial Veterans Hospital, Madison, WI

NM

Neal M Doran, PhD

Principal Investigator

VA San Diego Healthcare System, San Diego, CA

Eligibility Criteria

This trial is for veterans with a smoking addiction who aren't ready to quit yet. It's designed to help increase their chances of making quit attempts and achieving long-term abstinence from smoking.

Inclusion Criteria

If female, use an approved method of birth control while using study medication
Report smoking an average of 5 or more cigarettes daily for the previous 6 months
Be a Veteran
See 3 more

Exclusion Criteria

Use of non-cigarette tobacco products as primary form of tobacco use
Incarceration
I am unable to understand or agree to the study on my own.
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Motivation-Phase Treatment

Participants receive either varenicline or NRT mini-lozenges for 12 weeks, along with 5 phone counseling sessions focused on smoking reduction

12 weeks
5 visits (phone counseling)

Follow-up

Participants are monitored for smoking abstinence and quit attempts at 6 and 12 months post-study entry

12 months

Treatment Details

Interventions

  • Varenicline
Trial Overview The study tests different treatments: Varenicline (a medication) during both motivation and cessation phases, counseling in both phases, nicotine mini-lozenges during the motivation phase, and combination nicotine replacement therapy (NRT) during cessation.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Motivation-Phase VareniclineExperimental Treatment4 Interventions
Varenicline use during pre-quit phase of smoking treatment for participants who are interested in cutting down on their smoking.
Group II: Motivation-Phase Nicotine Mini-LozengeActive Control4 Interventions
NRT mini-lozenge use during pre-quit phase of smoking treatment for participants who are interested in cutting down on their smoking.

Find a Clinic Near You

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials
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Recruited
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