Behavioral Activation Therapy and Nicotine Replacement Therapy in Increasing Smoking Cessation (NCT02697227) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Behavioral Activation Therapy and Nicotine Replacement Therapy in Increasing Smoking Cessation
United States85 participantsStarted 2016-08-05
Plain-language summary
This randomized clinical trial studies how well behavioral activation therapy and nicotine replacement therapy work in increasing smoking cessation. Behavioral interventions use techniques to help patients change the way they react to environmental triggers that may cause a negative reaction. Giving behavioral activation therapy and nicotine replacement therapy may help patients quit smoking or change their smoking behavior.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Smoking 5 or more cigarettes, little cigars or cigarillos per day, on average, within the 2 months preceding the screening visit and expired carbon monoxide (CO) greater than or equal to 6 parts per million (ppm); (if \< 6, then NicAlert Strip \> 2)
* Interested in treatment that might change smoking behavior
* Able to follow verbal and written instructions in English and complete all aspects of the study
* Provide informed consent and agree to all assessments and study procedures
* Have an address and telephone number where they may be reached
* Be the only participant in their household
Exclusion Criteria:
* Within the month immediately preceding the screening visit, use of any form of tobacco products other than cigarettes, little cigars or cigarillos on 3 or more days within a week if the individual refuses to refrain from such tobacco use during the course of the study
* Current enrollment or plans to enroll in another smoking cessation program in the next 6 months
* Plan to use other nicotine substitutes (i.e., over-the-counter \[OTC\] or prescription medication for smoking cessation) or smoking cessation treatments in the next 6 months
* Uncontrolled hypertension (systolic blood pressure \[SBP\] greater than 180 or diastolic blood pressure \[DBP\] greater than 110)
* Reports diagnosis of seizure disorder or a history of neurological illness or closed head injury that in the opinion of the principal investigator (PI) or designated expert(s) feel…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing a behavioral activation therapy approach to standard cessation treatment, both combined with nicotine replacement therapy — could you explain what behavioral activation therapy actually involves day-to-day, and whether that kind of structured activity-based approach seems like a realistic fit for my lifestyle right now?
2The trial is measuring something called 'reward sensitivity' to decide how to analyze results — can you help me understand whether that concept is relevant to my own smoking pattern, and whether it might affect which type of cessation support is likely to work best for me?
3Since this trial is no longer recruiting but is still active, it sounds like the results aren't published yet — are there any early findings or similar completed studies you've seen that could give us a sense of whether behavioral activation therapy is likely to be helpful for someone in my situation?
4Given that this trial is testing behavioral activation therapy specifically for people who may have low motivation or difficulty experiencing reward, is there a way to tell whether I fit that profile, and should that influence which treatment approach we consider together?
5Nicotine replacement therapy is part of both arms of this trial — would standard nicotine replacement therapy combined with the kind of counseling already available to me be a reasonable starting point before pursuing anything more involved?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
Timeframe: Up to 4 months
2
Mediators of the behavioral activation treatment for smoking plus nicotine replacement therapy treatment effect in low reward sensitivity- smokers