Women Engaging in Quitting Smoking Together (WE QUIT)

Smoking Cessation Clinical Trial

— WE QUIT  

Official title:

Distress Tolerance Treatment for Weight Concern in Smoking Cessation Among Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02051803
• Other study ID #: 1303-003
• Secondary ID: K23DA035288
• Status: Completed
• Phase: N/A
• First received: January 30, 2014
• Last updated: July 30, 2015
• Start date: March 2014
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• Source: Butler Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The long-term goal of this program of research is to develop and disseminate an efficacious intervention for weight concern that will significantly increase smoking cessation rates among women. The overall objective of this project is to develop this intervention and modify it based on piloting and feedback to ensure its feasibility and acceptability. These objectives will be accomplished by pursuing the following specific aim: 1) develop a group-based distress tolerance treatment for weight concern (DT-W) in female smokers and a comparison health education (HE) program and pilot both treatments with three groups of 10 (total N = 30) female weight-concerned smokers (2 DT-W groups, 1 HE group).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• female

• 18 to 65 years of age

• smoke 10 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

• current diagnosis of depression

• 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

• current use of psychotropic medication except antidepressants

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

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

• Health Education (HE)

Locations

Country	Name	City	State
United States	Butler Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Butler Hospital	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Point prevalence abstinence from smoking	We will compare the percentage of participants in each treatment group who report abstinence from smoking for the 7 days prior to each follow-up assessment (1-, 3-, and 6-months post-quit date).	6 months from smoking quit date	No