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Behavioral Activation + Nicotine Patches for Smoking Cessation

N/A
Waitlist Available
Led By Jennifer A Minnix
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 months
Awards & highlights

Study Summary

This trial is testing whether two methods - behavioral activation therapy and nicotine replacement therapy - can help people quit smoking.

Who is the study for?
This trial is for adult cigarette smokers who smoke at least 5 cigarettes a day, want to quit or change their smoking habits, and can follow instructions in English. They must be the only participant from their household and have contact details. People with uncontrolled high blood pressure, certain neurological conditions, or using specific medications cannot join. Pregnant women or those not using effective birth control are also excluded.Check my eligibility
What is being tested?
The study tests whether combining behavioral activation therapy (a method that helps people react differently to triggers) with nicotine patches helps smokers quit or modify their behavior more effectively than other methods.See study design
What are the potential side effects?
Possible side effects may include skin irritation from the nicotine patch and typical withdrawal symptoms from quitting smoking such as increased appetite, mood swings, frustration, anxiety, difficulty concentrating, restlessness and cravings.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Effectiveness of behavioral activation treatment for smoking plus nicotine replacement therapy versus standard cessation treatment plus nicotine replacement therapy defined as abstinence rate in low reward sensitivity- and + smokers
Mediators of the behavioral activation treatment for smoking plus nicotine replacement therapy treatment effect in low reward sensitivity- smokers

Trial Design

2Treatment groups
Active Control
Group I: Group I (NRT, SC)Active Control4 Interventions
Patients receive NRT patch daily for 8 weeks. Patients receive individual behavioral treatment sessions consisting of behavioral treatment strategies for smoking cessation and health education information over 45 minutes for 8 sessions.
Group II: Group II (NRT, BATS)Active Control4 Interventions
Patients receive NRT patch daily for 8 weeks. Patients complete individual treatment sessions consisting of SC strategies and BA strategies over 45 minutes for 8 sessions.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,068 Total Patients Enrolled
93 Trials studying Tobacco Use Disorder
1,682,745 Patients Enrolled for Tobacco Use Disorder
M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,696 Total Patients Enrolled
10 Trials studying Tobacco Use Disorder
4,360 Patients Enrolled for Tobacco Use Disorder
Jennifer A MinnixPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
24 Total Patients Enrolled
1 Trials studying Tobacco Use Disorder
24 Patients Enrolled for Tobacco Use Disorder

Media Library

Behavioral Activation Therapy Clinical Trial Eligibility Overview. Trial Name: NCT02697227 — N/A
Tobacco Use Disorder Research Study Groups: Group I (NRT, SC), Group II (NRT, BATS)
Tobacco Use Disorder Clinical Trial 2023: Behavioral Activation Therapy Highlights & Side Effects. Trial Name: NCT02697227 — N/A
Behavioral Activation Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT02697227 — N/A
Tobacco Use Disorder Patient Testimony for trial: Trial Name: NCT02697227 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who can be admitted to this research protocol?

"The prerequisites for joining this medical trial are that patients have a history of tobacco use and lie between the age limits of 18 to 75. Currently, 85 individuals are being sought out for enrollment."

Answered by AI

Is this research enterprise actively seeking participants?

"At the present moment, this clinical trial is not accepting any more participants. Initially posted on August 5th 2016 and most recently updated September 22nd 2022, applicants should explore other studies for tobacco dependence as 117 trials are currently enrolling patients with Group II (NRT, BATS) having 71 opportunities available."

Answered by AI

Is the age criteria for this trial restricted to adults or are minors also eligible?

"This medical study is seeking participants who are under 75 and above the age of consent."

Answered by AI

Could you please detail any prior experiments that have included Group II (NRT, BATS)?

"Currently, 71 trials for Group II (NRT, BATS) are underway with 5 of them being in Stage 3. Although most studies related to this treatment occur at Greenville, South carolina there is a total of 204 locations running clinical trials."

Answered by AI

How many individuals have registered to participate in this trial?

"Sadly, the recruitment process for this trial has concluded. It was first made available on August 5th 2016 and its last edit took place on September 22nd 2022. On the other hand, there are still 117 studies actively enrolling those with tobacco dependence and 71 pursuing enrolments of participants in Group II (NRT, BATS)."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
What site did they apply to?
M D Anderson Cancer Center

Why did patients apply to this trial?

trying to get healthier by not smoking. I have tried to quit smoking on my own but that hasn't worked.
PatientReceived 1 prior treatment
~7 spots leftby Dec 2024