Smoking CessationNCT01259466
Internet-Administered Smoking Cessation Treatment for Overweight and Obese Smokers
A study testing Nicotine patch in people with Smoking Cessation and Overweight, run by Yale University at 1 site in United States.
Trial summary
This project will be a randomized clinical trial testing the efficacy of an internet-administered smoking cessation treatment for overweight and obese smokers. Research on internet-administered behavioral treatments for smoking cessation has found that compared to control treatments (e.g., self-help materials)… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Smoking Cessation, Overweight, Obesity
- What is being tested?
- Nicotine patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Nov 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Smoking 10 or more cigarettes per day
- Regular access to the internet
- BMI>=25
Who cannot join
- Type I diabetes or Type II diabetes requiring medication
- Alcohol or drug dependence within the past year
- Females with current pregnancy or breastfeeding or intention to become pregnant within the next 12 months
- Uncontrolled hypertension
- Severe chronic obstructive pulmonary disease
- Use of an investigational drug within 30 days or current participation in another clinical trial
Show all 10Show fewer
- Current use of tobacco products other than cigarettes or use of marijuana
- Use of nicotine replacement therapy, clonidine, varenicline, bupropion, or nortriptyline within the month prior to enrollment
- Use of a medication that might affect weight or appetite
- History of allergic reactions to adhesives.
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University School of Medicine
New Haven, Connecticut, 06520
About this study
This project will be a randomized clinical trial testing the efficacy of an internet-administered smoking cessation treatment for overweight and obese smokers. Research on internet-administered behavioral treatments for smoking cessation has found that compared to control treatments (e.g., self-help materials), cessation rates in internet-administered treatments are significantly higher. Research testing the applicability of these treatments to overweight and obese individuals has not yet been conducted. Given that a substantial portion of smokers are also overweight and at elevated cardiovascular risk, there is a need for directed treatment efforts for this group. The current trial proposes to be the first to test the effectiveness of internet-administered smoking cessation treatment for overweight and obese (BMI≥25) smokers. Adult participants will be randomized to receive 12 weeks of internet-administered treatment consisting of either: a) standard smoking cessation treatment with general health education, or b) standard smoking cessation treatment with cognitive behavioral therapy (CBT) for weight concerns. Participants in both conditions will receive open-label treatment with the 21 mg transdermal nicotine patch.
- Conditions
- Smoking Cessation, Overweight, Obesity
- Being tested
- Nicotine patch
- Keywords
- Smoking cessation, Overweight, Obesity, Internet treatment
- Medical subject headings
- Smoking Cessation, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine patchDrug
Also called Nicotine replacement
Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral + Nicotine Patch | Experimental | Cognitive Behavioral Therapy + Nicotine Replacement Patch Receives: Drug: Nicotine patch |
| Health Education + Nicotine Patch | Active comparator | Health Education + Nicotine Replacement Patch Receives: Drug: Nicotine patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Verified Smoking Cessation (Abstinence)
Continuous abstinence during the last 14 days of treatment, confirmed by biologically verified abstinence (CO level <10ppm)
Measured: Post-treatment (12-weeks)
Secondary outcomes (1)
Percent Weight Change
% Weight change: ((post-treatment weight - pre-treatment weight)/ pre-treatment weight) * 100
Measured: Post-treatment (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2010 (estimated)
- Study startJul 2010
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association
- Responsible party
- Principal investigator, Marney A. White, Yale University
- Investigators
- Marney A White, PhD, MS, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01259466
- Sponsor's protocol ID
- 1001006181
- Status last verified
- Aug 2015
- First submitted
- 11 Nov 2010
- Last updated
- 28 Sep 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-Administered Smoking Cessation Treatment for Overweight and Obese Smokers
- ClinicalTrials.gov ID
- NCT01259466
- Acronym / sponsor ID
- 1001006181
- Conditions
- Smoking Cessation, Overweight, Obesity
- Keywords
- Smoking cessation, Overweight, Obesity, Internet treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- American Heart Association
- Study start
- Jul 2010
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 14 Dec 2010 (estimated)
- Results
- Posted 28 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project will be a randomized clinical trial testing the efficacy of an internet-administered smoking cessation treatment for overweight and obese smokers. Research on internet-administered behavioral treatments for smoking cessation has found that compared to control treatments (e.g., self-help materials), cessation rates in internet-administered treatments are significantly higher. Research testing the applicability of these treatments to overweight and obese individuals has not yet been conducted. Given that a substantial portion of smokers are also overweight and at elevated cardiovascular risk, there is a need for directed treatment efforts for this group. The current trial proposes to be the first to test the effectiveness of internet-administered smoking cessation treatment for overweight and obese (BMI≥25) smokers. Adult participants will be randomized to receive 12 weeks of internet-administered treatment consisting of either: a) standard smoking cessation treatment with general health education, or b) standard smoking cessation treatment with cognitive behavioral therapy (CBT) for weight concerns. Participants in both conditions will receive open-label treatment with the 21 mg transdermal nicotine patch.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral + Nicotine Patch | Experimental | Drug: Nicotine patchCognitive Behavioral Therapy + Nicotine Replacement Patch |
| Health Education + Nicotine Patch | Active comparator | Drug: Nicotine patchHealth Education + Nicotine Replacement Patch |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Smoking 10 or more cigarettes per day
- Regular access to the internet
- BMI>=25
Key exclusion criteria (10 listed)
- Type I diabetes or Type II diabetes requiring medication
- Alcohol or drug dependence within the past year
- Females with current pregnancy or breastfeeding or intention to become pregnant within the next 12 months
- Uncontrolled hypertension
- Severe chronic obstructive pulmonary disease
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 |
|---|---|---|
| Nicotine patchAlso: Nicotine replacementTransdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks | Drug | Cognitive Behavioral + Nicotine Patch, Health Education + Nicotine Patch |
Primary outcome
Number of Participants With Verified Smoking Cessation (Abstinence)
Time frame: Post-treatment (12-weeks)
Continuous abstinence during the last 14 days of treatment, confirmed by biologically verified abstinence (CO level <10ppm)
1 secondary outcome
Percent Weight Change
Time frame: Post-treatment (12 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Marney A White, PhD, MS principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotine patch in people with Smoking Cessation and Overweight, run by Yale University 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 3 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 28 Sep 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?
Yes. Results are posted in the registry (first posted 28 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Verified Smoking Cessation (Abstinence) (time frame: Post-treatment (12-weeks)). 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 28 Sep 2015.