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New hope for veterans who smoke: a drug to help cut down without quitting first

NCT ID NCT06966362

Disease control Sponsor: VA Office of Research and Development Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 01, 2026 · Updated 5 times

Summary

This study tests whether the drug varenicline (Chantix) can help veterans who smoke at least 5 cigarettes a day but aren't ready to quit. Participants will either take varenicline or use nicotine lozenges to reduce smoking over 12 weeks. The goal is to see if this approach leads to more quit attempts and long-term abstinence. The trial will involve 400 veterans across the U.S.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Varenicline (Chantix) and nicotine mini-lozenge
What this could lead to
If successful, this could provide an effective way to help veterans who are not ready to quit smoking reduce their smoking and eventually quit, lowering their risk of smoking-related diseases.
What could go wrong
This is a phase 4 trial, so the drug is already approved, but it's testing a new use in a specific group. The results may not apply to all smokers, and side effects like nausea or sleep problems are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2026

Expected to finish

Jun 2030

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 (nicotine replacement therapy (NRT) or varenicline) * If female, use an approved method of birth control while using study medication * 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

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Conditions

The condition(s) this trial relates to.

Cigarette Smoking nicotine dependence Smoking Reduction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cigarette smoking Tobacco dependence Tobacco use disorder Veterans

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Durham VA Medical Center, Durham, NC

    RECRUITING

    Durham, North Carolina, 27705-3875, United States

  • Minneapolis VA Health Care System, Minneapolis, MN

    RECRUITING

    Minneapolis, Minnesota, 55417-2309, United States

  • VA San Diego Healthcare System, San Diego, CA

    RECRUITING

    San Diego, California, 92161-0002, United States

  • William S. Middleton Memorial Veterans Hospital, Madison, WI

    ACTIVE_NOT_RECRUITING

    Madison, Wisconsin, 53705-2254, United States

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