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OpenTrials
Completed

NCT Number: NCT02453659

Women Engaging in Quitting Smoking Together

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.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Distress Tolerance Treatment for Weight Concern (DT-W)

Behavioral

Health Education (HE)

Behavioral

Smoking Cessation Counseling

Behavioral

Transdermal Nicotine Patch

Drug

Primary outcomes

  1. 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

    Time frame: 6 months post-quit date

    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).

Sponsors and collaborators

Lead sponsor

Rhode Island Hospital

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Distress Tolerance Treatment for Weight Concern in Smoking Cessation Among Women

Acronym: WE QUIT

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
May 25, 2015
Registry last updated
Mar 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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