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Can a new therapy help cancer patients kick the habit?

NCT ID NCT01098955

Symptom relief Sponsor: M.D. Anderson Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study compares a new counseling approach called Acceptance and Commitment Therapy (ACT) with standard counseling to help people with head and neck, lung, breast, gastrointestinal, or genitourinary cancer stop smoking. About 51 adults who smoke at least one cigarette per day and are willing to use a quit-smoking medication will participate. The goal is to see which counseling method works better for long-term smoking abstinence.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

51 people

The number who actually took part.

Started

Mar 2010

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 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: 1. Current or history of head and neck, lung, breast, gastrointestinal, or genitourinary cancer 2. Age 18 or older 3. Smoking 1 cigarette or more per day at screening visit 4. English speaking and have a telephone 5. Willing to provide informed consent and agree to all assessments and study procedures 6. Recommended for and agreed to treatment with varenicline through the Tobacco Treatment Program 7. Plan to receive treatment for head and neck, lung, breast, gastrointestinal, or genitourinary cancer, currently undergoing treatment, or in follow-up care at M.D. Anderson Cancer Center Exclusion Criteria: 1. Anticipated hospitalization of 2 weeks or longer 2. Planned total laryngectomy 3. Current use of bupropion, nortriptyline, clonidine or nicotine replacement therapy 4. Currently receiving other forms of smoking cessation treatment 5. Severe levels of depressive symptoms, vegetative symptoms, and/or symptoms related to psychiatric disorders that place participant at risk for harm or require immediate treatment 6. Currently pregnant or lactating 7. Has received treatment in the TTP 8. History or/current medical condition, or any other factor that , in the judgment of the PI would likely preclude completion of study requirements

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Conditions

The condition(s) this trial relates to.

breast cancer digestive system cancer head and neck cancer Head and Neck Neoplasms lung cancer malignant urinary system neoplasm neoplasm Smoking Cessation

As listed by the trial registrant

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

Head and neck cancer Smoking cessation

Contacts and locations

Locations

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.