Smoking CessationWE QUITNCT02453659
Women Engaging in Quitting Smoking Together
A study testing Distress Tolerance Treatment for Weight Concern (DT-W), Health Education (HE) and Smoking Cessation counseling in people with Smoking Cessation, run by Rhode Island 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, group-based distress tolerance treatment for weight concern (DT-W) that will significantly increase smoking cessation rates among women. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Distress Tolerance Treatment for Weight Concern (DT-W), Health Education (HE) and Smoking Cessation counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Dec 2018
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Rhode Island Hospital
Providence, Rhode Island, 02903
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, 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.
- Conditions
- Smoking Cessation
- Being tested
- Distress Tolerance Treatment for Weight Concern (DT-W), Health Education (HE), Smoking Cessation counseling, Transdermal Nicotine Patch
- 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
Smoking Cessation counselingBehavioural
Transdermal Nicotine PatchDrug
| 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); Behavioral: Smoking Cessation counseling; Drug: Transdermal Nicotine Patch |
| 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); Behavioral: Smoking Cessation counseling; Drug: Transdermal Nicotine Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months post-quit date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02453659
- Sponsor's protocol ID
- 215114
- Other IDs
- K23DA035288
- Acronym
- WE QUIT
- Status last verified
- Mar 2019
- First submitted
- 21 May 2015
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.
PubMed 34611902
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. 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
- NCT02453659
- Acronym / sponsor ID
- WE QUIT / 215114
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- May 2015 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 25 May 2015 (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, 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.
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), Behavioral: Smoking Cessation counseling, Drug: Transdermal Nicotine PatchDT-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), Behavioral: Smoking Cessation counseling, Drug: Transdermal Nicotine PatchHE 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 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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) |
| Smoking Cessation counseling | Behavioural | Distress Tolerance Treatment for Weight Concern (DT-W), Health Education (HE) |
| Transdermal Nicotine Patch | Drug | Distress Tolerance Treatment for Weight Concern (DT-W), Health Education (HE) |
Primary outcome
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).
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 28 Mar 2019.
- Derived from this study: PubMed 34611902Hartmann-Boyce J, Theodoulou A, Farley A, Hajek P, Lycett D, Jones LL, Kudlek L, Heath L, Hajizadeh A, Schenkels M, Aveyard P. Interventions for preventing weight gain after smoking cessation. Cochrane Database Syst Rev. 2021 Oct 6;10(10):CD006219. doi: 10.1002/14651858.CD006219.pub4.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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), Health Education (HE) and Smoking Cessation counseling in people with Smoking Cessation, run by Rhode Island 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 8 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 28 Mar 2019. 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: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02453659, which also lists 1 linked publication.
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 28 Mar 2019.