Women Engaging in Quitting Smoking Together

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: NCT02453659
• Other study ID #: 215114
• Secondary ID: K23DA035288
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: December 2018

Study information

• Verified date: March 2019
• Source: Rhode Island Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

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

• Health Education (HE)

• Smoking Cessation counseling

Drug:
• Transdermal Nicotine Patch

Locations

Country	Name	City	State
United States	Rhode Island Hospital	Providence	Rhode Island

Sponsors (2)

Lead Sponsor	Collaborator
Rhode Island 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: percentage of participants in each treatment group who report abstinence from smoking for the 7 days prior to each follow-up assessment	The investigators 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 post-quit date