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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
Must not have
Pregnant, breast-feeding or of childbearing potential and is not protected by a medically acceptable, effective method of birth control while enrolled in the study; medically acceptable contraceptives include: (1) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (2) barrier methods (such as a condom or diaphragm) used with a spermicide, or (3) an intrauterine device (IUD); contraceptive measures sold for emergency use after unprotected sex are not acceptable methods for routine use
Positive toxicology screen for any of the following drugs: cocaine, opiates, methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, or phencyclidine (PCP)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 months
Awards & highlights
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.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not pregnant, breastfeeding, and if capable of childbearing, I use effective birth control.
Select...
I have not tested positive for drugs like cocaine, opiates, or meth.
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
13,748 Previous Clinical Trials
40,959,316 Total Patients Enrolled
93 Trials studying Tobacco Use Disorder
1,682,666 Patients Enrolled for Tobacco Use Disorder
M.D. Anderson Cancer CenterLead Sponsor
3,002 Previous Clinical Trials
1,794,194 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
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