Nicotine DependenceProject-WINNCT01061528
Coping Skills Treatment for Smoking Cessation
A study testing Transdermal Nicotine in people with Nicotine Dependence, run by Butler Hospital at 1 site in United States.
Trial summary
The primary purpose of this study is to evaluate the efficacy of a new type of exposure- and acceptance-based smoking cessation treatment vs. standard behavioral smoking cessation treatment, in conjunction with the use of the transdermal nicotine patch. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- Transdermal Nicotine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Oct 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-65 years old
- regular smoker for at least one year
- currently smoking 10 or more cigarettes per day
Who cannot join
- Current Axis I disorder
- Psychoactive substance abuse or dependence (excluding nicotine dependence) within past year
- Current suicidal risk
- Pregnancy or breast feeding
- Use of nicotine replacement products or bupropion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Distress Tolerance Treatment for Smoking Cessation
The primary purpose of this study is to evaluate the efficacy of a new type of exposure- and acceptance-based smoking cessation treatment vs. standard behavioral smoking cessation treatment, in conjunction with the use of the transdermal nicotine patch. In both treatments, participants will receive one 60-minute individual session, seven 2-hour group sessions and two individual brief telephone contacts over an eight-week period. Both treatments include 8 weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue after the treatment sessions have ended. Participants will provide follow-up data with regard to their smoking status through a one-year follow-up period.
Read the detailed description
- 18-65 years of age,
- a regular smoker for at least one year,
- currently smoking 10 or more cigarettes per day,
- report motivation to quit smoking in the next month.
- Conditions
- Nicotine Dependence
- Being tested
- Transdermal Nicotine
- Keywords
- cigarette smoking, smoking cessation, nicotine dependence
- Medical subject headings
- Tobacco Use Disorder, Cigarette Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdermal NicotineDrug
Also called Nicoderm CQ
Participants will use the full strength 21mg. patch for 4 weeks, will taper to the 14 mg. patch for the next 2 weeks, and then to the 7 mg. patch for the remaining 2 weeks of treatment.
| Study group | Role | What they receive |
|---|---|---|
| New Smoking Cessation Counseling | Experimental | * One 60-minute individual session
* Seven 2-hour group sessions
* Two individual brief telephone contacts over an eight-week period.
* Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue even after the treatment sessions have ended. Standard nicotine patch dosing will be used. Receives: Drug: Transdermal Nicotine |
| Standard Smoking Cessation Counseling | Active comparator | * One 60-minute individual session
* Seven 2-hour group sessions
* Two individual brief telephone contacts over an eight-week period.
* Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue even after the treatment sessions have ended. Standard nicotine patch dosing will be used. Receives: Drug: Transdermal Nicotine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Biochemically Verified Smoking Abstinence
- Carbon monoxide of expired air
- Salivary cotinine level of saliva
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2010 (estimated)
- Study startSep 2009
- Primary completionAug 2013
- Study completionOct 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 Nicotine DependenceStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 116 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
- Richard A Brown, PhD, Principal investigator, Butler Hospital/Brown Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01061528
- Sponsor's protocol ID
- PHI0906-002
- Other IDs
- R01DA017332
- Acronym
- Project-WIN
- Status last verified
- Sep 2018
- First submitted
- 2 Feb 2010
- Last updated
- 16 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distress Tolerance Treatment for Smoking Cessation
- ClinicalTrials.gov ID
- NCT01061528
- Acronym / sponsor ID
- Project-WIN / PHI0906-002
- Conditions
- Nicotine Dependence
- Keywords
- cigarette smoking, smoking cessation, nicotine dependence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Sep 2009
- Primary completion
- Aug 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 3 Feb 2010 (estimated)
- Results
- Posted 15 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to evaluate the efficacy of a new type of exposure- and acceptance-based smoking cessation treatment vs. standard behavioral smoking cessation treatment, in conjunction with the use of the transdermal nicotine patch. In both treatments, participants will receive one 60-minute individual session, seven 2-hour group sessions and two individual brief telephone contacts over an eight-week period. Both treatments include 8 weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue after the treatment sessions have ended. Participants will provide follow-up data with regard to their smoking status through a one-year follow-up period.
Detailed description
- 18-65 years of age,
- a regular smoker for at least one year,
- currently smoking 10 or more cigarettes per day,
- report motivation to quit smoking in the next month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New Smoking Cessation Counseling | Experimental | Drug: Transdermal Nicotine* One 60-minute individual session * Seven 2-hour group sessions * Two individual brief telephone contacts over an eight-week period. * Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue even after the treatment sessions have ended. Standard nicotine patch dosing will be used. |
| Standard Smoking Cessation Counseling | Active comparator | Drug: Transdermal Nicotine* One 60-minute individual session * Seven 2-hour group sessions * Two individual brief telephone contacts over an eight-week period. * Eight weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue even after the treatment sessions have ended. Standard nicotine patch dosing will be used. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-65 years old
- regular smoker for at least one year
- currently smoking 10 or more cigarettes per day
Key exclusion criteria (5 listed)
- Current Axis I disorder
- Psychoactive substance abuse or dependence (excluding nicotine dependence) within past year
- Current suicidal risk
- Pregnancy or breast feeding
- Use of nicotine replacement products or bupropion
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 |
|---|---|---|
| Transdermal NicotineAlso: Nicoderm CQParticipants will use the full strength 21mg. patch for 4 weeks, will taper to the 14 mg. patch for the next 2 weeks, and then to the 7 mg. patch for the remaining 2 weeks of treatment. | Drug | New Smoking Cessation Counseling, Standard Smoking Cessation Counseling |
Primary outcome
Number of Participants With Biochemically Verified Smoking Abstinence
Time frame: Six months
1. Carbon monoxide of expired air 2. Salivary cotinine level of saliva
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Richard A Brown, PhD principal investigator
Butler Hospital/Brown Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transdermal Nicotine in people with Nicotine Dependence, 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 3 inclusion and 5 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 16 Oct 2018. 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 15 Jun 2018). 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 Biochemically Verified Smoking Abstinence (time frame: Six months). 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 16 Oct 2018.