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Smoking Cessation Treatment for Head & Neck Cancer Patients

Phase < 1
Waitlist Available
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Current or history of head and neck, lung, breast, gastrointestinal, or genitourinary cancer
Age 18 or older
Must not have
Current use of bupropion, nortriptyline, clonidine or nicotine replacement therapy
Has received treatment in the TTP
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 6 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial is designed to study and compare the effectiveness of two types of counseling for cancer patients who want to quit smoking: Acceptance and Commitment Therapy (ACT) and Motivational and Behavioral Counseling (MBC).

Who is the study for?
This trial is for English-speaking adults over 18 with a current or past diagnosis of head and neck, lung, breast, gastrointestinal, or genitourinary cancer who smoke. They must be recommended for varenicline treatment and able to consent to study procedures. Exclusions include planned long hospital stays, certain surgeries, use of specific smoking cessation drugs or treatments, severe depression or psychiatric risk factors.
What is being tested?
The study compares two types of counseling: Acceptance and Commitment Therapy (investigational) versus Motivational and Behavioral Counseling (standard). It aims to determine which is more effective in helping patients quit smoking alongside their prescribed varenicline treatment.
What are the potential side effects?
Potential side effects from the counseling sessions are minimal but may include emotional discomfort due to discussing personal issues related to smoking habits. Varenicline can cause nausea, sleep disturbances, mood changes, headaches, and increased appetite.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have or had cancer in my head, neck, lung, breast, stomach area, or reproductive organs.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am currently using bupropion, nortriptyline, clonidine, or nicotine replacement therapy.
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I have received treatment in the time to progression.
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I am scheduled for a complete removal of my voice box.
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I am experiencing severe depression or other mental health issues that could harm me.
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I am currently using treatments to help me stop smoking.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Smoking Abstinence Rate

Side effects data

From 2022 Phase 4 trial • 39 Patients • NCT04011280
50%
Dysgeusia
50%
Anxiety
36%
Sleep Disturbances
29%
Nausea
21%
Agitation
21%
Depression
21%
Headache
14%
Heartburn
14%
Allergies
14%
Cold
14%
Back Pain
7%
Confusion
7%
Aggression
7%
Panic
7%
Stomach Pain
7%
Dizziness
7%
Fatigue
7%
Leg Spasms
7%
Sinusitis
7%
Angina
7%
Increased Blood Pressure
7%
Palpitations
7%
Cellulitis
7%
Rash
7%
Malaise
7%
Weight Gain
7%
Gum Disease
7%
Pharyngitis
7%
Leg Cramps
7%
Muscle Pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Low Dose Varenicline
Standard Dose Varenicline

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: MBC Group 2Experimental Treatment2 Interventions
Motivational and Behavioral Counseling (MBC). Varenicline 2 mg daily for 12 weeks.
Group II: ACT Group 1Experimental Treatment2 Interventions
Acceptance and Commitment Therapy (ACT). Varenicline 2 mg daily for 12 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acceptance and Commitment Therapy
2010
Completed Phase 1
~1490
Varenicline
2011
Completed Phase 4
~4170

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,957 Previous Clinical Trials
41,112,036 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
3,074 Previous Clinical Trials
1,803,296 Total Patients Enrolled
Jan Blalock, PhDStudy ChairM.D. Anderson Cancer Center
1 Previous Clinical Trials
91 Total Patients Enrolled

Media Library

Acceptance and Commitment Therapy Clinical Trial Eligibility Overview. Trial Name: NCT01098955 — Phase < 1
Smoking Cessation Research Study Groups: ACT Group 1, MBC Group 2
Smoking Cessation Clinical Trial 2023: Acceptance and Commitment Therapy Highlights & Side Effects. Trial Name: NCT01098955 — Phase < 1
Acceptance and Commitment Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT01098955 — Phase < 1
~2 spots leftby Sep 2025
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