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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 months
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
13,687 Previous Clinical Trials
40,930,286 Total Patients Enrolled
93 Trials studying Tobacco Use Disorder
1,682,745 Patients Enrolled for Tobacco Use Disorder
M.D. Anderson Cancer CenterLead Sponsor
2,976 Previous Clinical Trials
1,789,423 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not been hospitalized for psychiatric reasons in the last year.I plan to use nicotine substitutes or smoking cessation treatments soon.I am not pregnant, post-menopausal for two years, or have had surgery to prevent pregnancy.I am not pregnant, breastfeeding, and if capable of childbearing, I use effective birth control.I am willing to adjust my hairstyle or remove a wig for the study.I have a history of seizures or brain injury that might affect EEG results.I haven't taken smoking cessation or certain depression meds recently.I have not tested positive for drugs like cocaine, opiates, or meth.I have a prescription for certain controlled medications and can still participate.You have had an allergic reaction or are sensitive to the ingredients in the NRT (nicotine replacement therapy) product.You have been assessed and found to have a moderate to high risk of suicidal thoughts or behaviors.You are open to trying treatments that may help you quit smoking or change your smoking habits.
Research Study Groups:
This trial has the following groups:- Group 1: Group I (NRT, SC)
- Group 2: Group II (NRT, BATS)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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