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Behavioral Intervention

Contingency Management for Tobacco Use Disorder (CM_TUD_Cancer Trial)

N/A

Recruiting

Led By Ellen Herbst, MD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 years or older

Be older than 18 years old

Must not have

Metastatic cancer or enrollment in end of life/ palliative care

Currently pregnant or planning to become pregnant during the study (people of childbearing potential ages 18-55 who are pregnant or state that they plan to become pregnant during the study)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up phase 3, weeks 0, 5, 12, 24

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to see if a program called Contingency Management (CM) can help US Veterans quit smoking during lung cancer screening or cancer care at VA clinics. CM is a reward-based program that

Who is the study for?

This trial is for US Veterans who are either undergoing lung cancer screening or receiving cancer care at VA clinics and want to quit smoking. They must be willing to participate in focus groups, use a mobile program, and undergo biological testing to verify smoking cessation.

What is being tested?

The study tests Contingency Management (CM), which rewards Veterans for quitting smoking, verified by tests. It includes developing a mobile CM protocol with Veteran/staff input, then piloting it alongside counseling and medication over five weeks to assess feasibility.

What are the potential side effects?

Since the interventions include behavioral treatments like Cognitive Behavioral Therapy (CBT) and rewards-based programs rather than medications, side effects may be minimal but could include stress or anxiety related to behavior change efforts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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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My cancer has spread, or I am receiving end-of-life care.

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I am not pregnant and do not plan to become pregnant during the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Score on the Contemplation Ladder

Change in Scores on the Fagerström Test for Nicotine Dependence (FTND)

Change in Scores on the Questionnaire on Smoking Urges (QSU-Brief)

+13 more

Secondary study objectives

Change in Percentage of Participants with Point Prevalent Abstinence

Change in Timeline Follow-Back (TLFB): E-cigarettes

Change in Timeline Follow-Back (TLFB): Other tobacco products

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Focus GroupExperimental Treatment1 Intervention

The investigators will iteratively develop an acceptable mobile CM protocol using qualitative feedback from Veterans in VA patients in LCS or in cancer care and LCS and oncology staff.

Group II: Contingency ManagementExperimental Treatment2 Interventions

Veterans in VA LCS or cancer care will receive mobile CM plus behavioral counseling and cessation medication over 5 weeks.

Group III: TUD Treatment as UsualActive Control2 Interventions

Participants assigned to TAU will receive time-matched Medication Management plus usual care (referral to VA Tobacco Cessation Clinic and provision of the VA Telequit quitline).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Focus Group

2017

Completed Phase 1

~4710

Contingency Management

2014

Completed Phase 4

~3440