Smoking CessationWE QUITNCT02051803
Women Engaging in Quitting Smoking Together (WE QUIT)
A study testing Distress Tolerance Treatment for Weight Concern (DT-W) and Health Education (HE) in people with Smoking Cessation, run by Butler Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Distress Tolerance Treatment for Weight Concern (DT-W) and Health Education (HE)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Distress Tolerance Treatment for Weight Concern in Smoking Cessation Among Women
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).
- Conditions
- Smoking Cessation
- Being tested
- Distress Tolerance Treatment for Weight Concern (DT-W), Health Education (HE)
- Keywords
- smoking cessation, women
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distress Tolerance Treatment for Weight Concern (DT-W)Behavioural
Health Education (HE)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| Distress Tolerance Treatment for Weight Concern (DT-W) | Experimental | 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. Receives: Behavioral: Distress Tolerance Treatment for Weight Concern (DT-W) |
| Health Education (HE) | Active comparator | 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. Receives: Behavioral: Health Education (HE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months from smoking quit date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study startMar 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Erika L. Bloom, Ph.D., Principal investigator, Butler Hospital and Rhode Island Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02051803
- Sponsor's protocol ID
- 1303-003
- Other IDs
- K23DA035288
- Acronym
- WE QUIT
- Status last verified
- Jul 2015
- First submitted
- 30 Jan 2014
- Last updated
- 31 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distress Tolerance Treatment for Weight Concern in Smoking Cessation Among Women
- ClinicalTrials.gov ID
- NCT02051803
- Acronym / sponsor ID
- WE QUIT / 1303-003
- Conditions
- Smoking Cessation
- Keywords
- smoking cessation, women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Mar 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 31 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Distress Tolerance Treatment for Weight Concern (DT-W) | Experimental | Behavioral: 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. |
| Health Education (HE) | Active comparator | Behavioral: 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Distress Tolerance Treatment for Weight Concern (DT-W) | Behavioural | Distress Tolerance Treatment for Weight Concern (DT-W) |
| Health Education (HE) | Behavioural | Health Education (HE) |
Primary outcome
Point prevalence abstinence from smoking
Time frame: 6 months from smoking quit date
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erika L. Bloom, Ph.D. principal investigator
Butler Hospital and Rhode Island Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distress Tolerance Treatment for Weight Concern (DT-W) and Health Education (HE) in people with Smoking Cessation, run by Butler Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Point prevalence abstinence from smoking (time frame: 6 months from smoking quit date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2015.