Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2015-05-31
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Distress Tolerance Treatment for Weight Concern (DT-W)
DT-W is delivered over a 9 week period with 1 1-hr individual session during week 1, 8 weekly 1.5-hr group counseling sessions during weeks 2-9, and 1 20-minute individual telephone session during week 4. Session content includes distress tolerance intervention for weight concern plus standard behavioral smoking cessation treatment. Participants also receive 8 weeks of nicotine patch.
Distress Tolerance Treatment for Weight Concern (DT-W)
Smoking Cessation counseling
Transdermal Nicotine Patch
Health Education (HE)
HE is delivered over a 9 week period with 1 1-hr individual session during week 1, 8 weekly 1.5-hr group counseling sessions during weeks 2-9, and 1 20-minute individual telephone session during week 4. Session content includes smoking health education program plus standard behavioral smoking cessation treatment. Participants also receive 8 weeks of nicotine patch.
Health Education (HE)
Smoking Cessation counseling
Transdermal Nicotine Patch
Interventions
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Distress Tolerance Treatment for Weight Concern (DT-W)
Health Education (HE)
Smoking Cessation counseling
Transdermal Nicotine Patch
Eligibility Criteria
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Inclusion Criteria
* at least 18 years of age
* smoke 5 or more cigarettes per day
* daily smoker for at least the past year
* report motivation to quit smoking in the next month of at least 5 on a 10 point scale
* report concern of at least 50 on at least one of two 100 point scales assessing weight concern
* able to travel to study location for study appointments
Exclusion Criteria
* current use of other tobacco products at least weekly
* diagnosis or treatment for non-nicotine substance use disorder with substance use during the past 6 months
* lifetime diagnosis or treatment of eating disorder, bipolar disorder, schizophrenia, or schizoaffective disorder
* score above established cut-offs on self-report screening measures of depressive symptomology, eating disorder symptomology, alcohol use disorder, or drug use disorder
* current suicidality or homicidality
* medical condition that is a contraindication for the use of transdermal nicotine patch
* lives at same address as current or past participant
18 Years
FEMALE
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Rhode Island Hospital
OTHER
Responsible Party
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Locations
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Rhode Island Hospital
Providence, Rhode Island, United States
Countries
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References
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Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.
Other Identifiers
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215114
Identifier Type: -
Identifier Source: org_study_id
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