- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04130698
Comparing Two Treatments That Both Target Smoking Cessation and Weight Loss at the Same Time. (BREATH)
Biobehavioral Regulation to Extinguish Smoking While Treating Another Health Risk
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In Phase 1, the investigators will revise the distress tolerance (DT) protocol the investigators developed in a previous study. Currently, the DT protocol is comprised of 6 two-hour weekly group sessions. However, based on the data the investigators collected in the previous study, the investigators will revise the DT protocol to have 7 instead of 6 two-hour weekly group sessions. 6 subjects (1 group) will be recruited to pilot the revised DT protocol. All subjects in the pilot will receive the transdermal nicotine patch (TNP). Prior to initiating use of the TNP on quit day, all subjects will be educated about its use and instructed to comply with all the recommended guidelines for usage as outlined in the directions. Smokers who lapse during treatment will be encouraged to set a new quit date and continue to attempt to quit. Subjects who continue to smoke or lapse after quit day will not be instructed to discontinue the patch unless their smoking level reaches 4 cigarettes/day for 4 days. This recommendation is consistent with safe TNP use. Smoking cessation will be objectively verified by expired carbon monoxide levels and saliva cotinine assays. Specifically, subjects who self-report nicotine abstinence will provide an exhaled breath into a Bedfont Micro Smokerlyzer to measure carbon monoxide levels and provide an adequate amount of saliva for cotinine analyses. RAs will wear non-latex gloves and follow all safety protocols for data collection and storage for biochemical materials. the investigators will use an 8ppm cutoff for expired carbon monoxide levels for stated abstinence of 24 hours for 2 weeks and use a cutoff of 10ng/ml for saliva cotinine assays for stated abstinence of 2 weeks or more as cotinine may be incompletely metabolized before this time. Expired carbon monoxide results will be immediately available. Saliva samples will be frozen for shipment to the American Health Foundation (Valhalla, NY) for cotinine level determination by radioimmune assay. Detected values above the stated cutoffs will be considered indicative of smoking. Therefore, smoking cessation and weight loss will be assessed using expired carbon monoxide and weigh-ins during the intervention and saliva cotinine assays and weigh-ins at follow-ups. During Phase 1 post-intervention follow-up, the investigators will revise the active health control protocol comprised of standard treatment for smoking cessation and weight loss to make sure it equates for intervention contact time.
In Phase 2, 48 subjects (8 groups of 6) will be recruited. Both conditions will receive the TNP and follow the protocol previously outlined in Phase 1. Once 6 eligible subjects are recruited, random assignment will be used to determine which of the two treatment conditions the group will receive. We expect to recruit 6 subjects within two weeks, reducing the lag time between a subject's eligibility and starting the intervention. Compensation for subjects' time will also support timely recruitment. To ensure an equal number of groups are assigned to each of the two conditions, assignment will be completed by choosing from among a fixed pool of 8 entries (4 from each condition). Smoking cessation and weight loss outcomes will be assessed using biochemical measures and weigh-ins during the intervention and at follow-up.
Study Type
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Rhode Island
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Providence, Rhode Island, United States, 02908
- Rhode Island College
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- between 18-64 years old
- have been a regular smoker for at least three years
- meet DSM-IV criteria for nicotine dependence
- smoke on average 10 cigarettes per day
- are overweight or obese (25<BMI<40)
- report motivation to quit smoking and lose weight
- speak English.
Exclusion Criteria:
- engaged in a smoking cessation or weight loss intervention
- use medications known to affect smoking cessation or weight loss
- have a medical condition that is a contraindication for transdermal nicotine patch (TNP)
- regularly use other tobacco products
- endorse active suicidal or homicidal ideation
- self-report or meet diagnostic criteria for an alcohol or drug dependence
- self-report or meet diagnostic criteria for an eating or neurocognitive disorder
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Distress Tolerance
Treatment rationale: RAs will explain that there are 3 (not 2 as in the control) key factors that maintain smoking behavior and excess weight: 1) learned habits, 2) the addictive properties of smoking and food, and 3) a way to manage distress. Therefore, to be effective, an intervention designed to simultaneously treat smoking cessation and weight loss must address all 3 key factors. This condition includes both key factors in the control but introduces the third key factor distress tolerance (DT). Toward that end, modules will include: a values discussion; experiential avoidance; distress tolerance; and mindfulness-based ways to manage distress. Module 1: Orientation & ACT; Module 2: Avoidance; Module 3: Cognitive Fusion vs. Defusion; Module 4: Self-As-Context; Module 5: Present-Moment-Awareness; and Module 6: Values and Committed Action. |
The group-level intervention is comprised of one 2-hour weekly group sessions with overweight smokers to learn skills and strategies consistent with distress tolerance intervention to quit smoking and lose weight.
Participants will use the patch for 8 weeks as outlined by the recommended usage for steps 1-3 going from 21mg for 4 weeks, 14mg for 1 week, and 7mg for 1 week.
Other Names:
|
ACTIVE_COMPARATOR: Active Health Control
Treatment rationale: RAs will explain that there are 2 key factors that maintain smoking behavior and excess weight: 1) learned habits and 2) the addictive properties of smoking and food. Therefore, to be effective, an intervention designed to simultaneously treat smoking cessation and weight loss must address both key factors. Toward that end, modules will include standard treatment on: the dangers of smoking, excess weight, unhealthy diets and sedentariness; the importance of healthy behaviors; and relaxation exercises to manage stress. These are all key aspects of standard treatment for smoking cessation and weight loss. Module 1: Orientation and Health; Module 2: Game Plan; Module 3: Stress and Coping Strategies; Module 4: Physical Activity; Module 5: Changes in Activities, Habits and Lifestyle; and Module 6: Long-Term Rewards. |
Participants will use the patch for 8 weeks as outlined by the recommended usage for steps 1-3 going from 21mg for 4 weeks, 14mg for 1 week, and 7mg for 1 week.
Other Names:
The group-level intervention is comprised of one 2-hour weekly group sessions with overweight smokers to learn skills and strategies consistent with psychoeducation intervention to quit smoking and lose weight.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
7-day point-prevalence abstinence from smoking
Time Frame: 6-month follow-up assessments from the end of intervention.
|
saliva cotinine assays
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6-month follow-up assessments from the end of intervention.
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5% lower weight from baseline.
Time Frame: 6-month follow-up assessments from the end of intervention
|
weigh-ins
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6-month follow-up assessments from the end of intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Include latency to first smoking lapse and latency to smoking relapse
Time Frame: 6-month follow-up assessments from the end of intervention.
|
saliva cotinine assays
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6-month follow-up assessments from the end of intervention.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jayson J Spas, PhD, MS, Associate Professor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1819-1483
- R15DA045917-01A1 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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