Women Engaging in Quitting Smoking Together (WE QUIT)

Lifespan

Status: Completed

Conditions: Smoking Cessation

Treatments: Behavioral: Health Education (HE); Behavioral: Distress Tolerance Treatment for Weight Concern (DT-W); Behavioral: Smoking Cessation counseling; Drug: Transdermal Nicotine Patch

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02453659

K23DA035288 (U.S. NIH Grant/Contract)

215114

Details and patient eligibility

About

The long-term goal of this program of research is to develop and disseminate an efficacious, group-based distress tolerance treatment for weight concern (DT-W) that will significantly increase smoking cessation rates among women. The objective of this project is to conduct a preliminary randomized controlled trial (RCT) (N = 60) comparing DT-W to a Health Education (HE) comparison intervention, in which both groups also receive standard behavioral smoking cessation treatment (ST) including counseling and transdermal nicotine patch (TNP), and examine potential mechanisms that may underlie the efficacy of DT-W in improving smoking outcomes at 1-, 3-, and 6-month follow-ups.

Enrollment: 100 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

female

• 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 smoking cessation or weight loss therapies
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Distress Tolerance Treatment for Weight Concern (DT-W)

Experimental group

Description:

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.

Treatment:

Drug: Transdermal Nicotine Patch

Behavioral: Distress Tolerance Treatment for Weight Concern (DT-W)

Behavioral: Smoking Cessation counseling

Health Education (HE)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Health Education (HE)

Drug: Transdermal Nicotine Patch

Behavioral: Smoking Cessation counseling