Nicotine DependencePhase 1NCT01422239
A Smoking Cessation Treatment for Adult Women
A Phase 1 study testing Tailored treatment and Standard Treatment in people with Nicotine Dependence, run by Yale University at 1 site in United States.
Trial summary
The purpose of this study is to develop and pilot test a smoking cessation counseling that focuses on the perceived risks of quitting smoking (e.g., weight gain, managing cravings and negative affect, loss of enjoyment). Aim 1: To develop the risk-based smoking cessation intervention. Read more about this study
- Who is it for?
- Ages 18 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- Tailored treatment and Standard Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Dec 2012
- Phase
- Phase 1
- 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 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between the ages of 18 and 64 years old
- Meet Diagnostic and Statistical Manual-IV (DSM-IV) criteria for nicotine dependence with Fagerström Test for Nicotine Dependence (FTND) score ≥4
- Smoke at least 15 cigarettes (3/4 pack) daily (averaged over 1 week, in the past 1 month) and have an expired breath carbon monoxide (CO) level ≥10
- At the time of initial evaluation, are motivated to quit smoking in the next 30 days.
- Have the capacity to give informed consent, and are English-speaking.
Who cannot join
- Have a positive urine drug screen or urine pregnancy test at baseline evaluation
- Meet DSM-IV criteria for alcohol or other drug abuse or dependence in the previous 6 months
- Meet DSM-IV criteria for a current diagnosis of major depressive disorder, panic disorder or post-traumatic stress disorder
- Meet DSM-IV criteria for a current or past diagnosis of bipolar disorder or schizophrenia
- Are currently receiving treatment for nicotine dependence (e.g., nicotine replacement therapy, bupropion, chantix)
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale University School of Medicine, Department of Psychiatry
New Haven, Connecticut, 06519
About this study
The purpose of this study is to develop and pilot test a smoking cessation counseling that focuses on the perceived risks of quitting smoking (e.g., weight gain, managing cravings and negative affect, loss of enjoyment).
Aim 1: To develop the risk-based smoking cessation intervention.
Read more
Aim 2: To examine whether manualized smoking cessation counseling about the perceived risks of quitting is feasible to administer and acceptable to adult women who want to quit smoking.
Aim 3: To examine smoking cessation outcomes for women who receive the risk-based treatment in comparison to standard smoking counseling. It is expected that women who receive risk-based counseling will show better quit rates and a longer time to relapse than women who receive standard treatment.
Read the detailed description
The purpose of this treatment development study is to design and pilot test a smoking cessation intervention in which counseling sessions are tailored to individual smokers' perceived risks of quitting. The feasibility, acceptability, and efficacy of the novel treatment will be examined through a pilot study in which female smokers will be randomly assigned to receive either the tailored treatment or a standard treatment. It is expected that participants receiving the tailored treatment will show higher rates of smoking abstinence than participants receiving the standard smoking cessation treatment at the end of the 8-week treatment and at one month follow-up.
- Conditions
- Nicotine Dependence
- Being tested
- Tailored treatment, Standard Treatment
- Keywords
- smoking, treatment, perceived risks
- Medical subject headings
- Tobacco Use Disorder, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored treatmentBehavioural
8 sessions of individual behavioral counseling. The first 3 sessions will be 45 minutes long and include 30 minutes tailored to the perceived risks of quitting most strongly held by each participant. The final 5 sessions will be 30 minutes long and include material from the Mayo Clinic's smoking cessation manual.
Standard TreatmentBehavioural
8 sessions of individual behavioral counseling. The first 3 sessions will be 45 minutes long and include 30 minutes focused on the benefits of quitting smoking. The final 5 sessions will be 30 minutes long and include material from the Mayo Clinic's smoking cessation manual.
| Study group | Role | What they receive |
|---|---|---|
| Tailored behavioral counseling | Experimental | The focus of the first three sessions for participants receiving the tailored treatment will be their three most highly endorsed perceived risks of quitting. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's "Smoke Free and Living It" manual. The last 5 counseling sessions will be based on perceived risks of quitting. Receives: Behavioral: Tailored treatment |
| Standard behavioral counseling | Active comparator | The focus of the first three sessions for participants receiving the standard treatment will be the benefits of quitting smoking. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's "Smoke Free and Living It" manual. All participants will receive identical counseling sessions during week 4-8 based on material from the Mayo Clinic manual. Receives: Behavioral: Standard Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Point-prevalence Smoking Abstinence Assessed at the End of the Trial and Measured by Self-report and Confirmed by Carbon Monoxide Levels
point-prevalence smoking abstinence assessed at the end of the trial and measured by self-report (no smoking reported in the previous 7 days) and confirmed by carbon monoxide levels (CO levels < 5ppm)
Measured: Up to 8 weeks
Secondary outcomes (2)
Point-prevalence Smoking Abstinence Four Weeks After the End of the Trial Assessed by Self-report and Carbon Monoxide Levels
point-prevalence smoking abstinence assessed at one month after the completion of counseling and measured by self-report (no smoking reported in the previous 7 days) and confirmed by carbon monoxide levels (CO levels < 5ppm)
Measured: 12 weeks
Change in Smoking From Baseline to the Followup Assessment (Week 12)
Change in number of cigarettes per day (CPD) (averaged over the previous week) from the baseline assessment (Week 0) to the followup assessment (Week 12) for participants who did not quit smoking during the study.
Measured: Week 0 (baseline), Week 12 (one month followup)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2012
- Study completionDec 2012
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.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Andrea H. Weinberger, Ph.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01422239
- Sponsor's protocol ID
- 1007007059
- Status last verified
- Apr 2020
- First submitted
- 19 Aug 2011
- Last updated
- 20 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Smoking Cessation Treatment for Adult Women
- ClinicalTrials.gov ID
- NCT01422239
- Acronym / sponsor ID
- 1007007059
- Conditions
- Nicotine Dependence
- Keywords
- smoking, treatment, perceived risks
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Jan 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 23 Aug 2011 (estimated)
- Results
- Posted 7 Jun 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to develop and pilot test a smoking cessation counseling that focuses on the perceived risks of quitting smoking (e.g., weight gain, managing cravings and negative affect, loss of enjoyment).
Aim 1: To develop the risk-based smoking cessation intervention.
Aim 2: To examine whether manualized smoking cessation counseling about the perceived risks of quitting is feasible to administer and acceptable to adult women who want to quit smoking.
Aim 3: To examine smoking cessation outcomes for women who receive the risk-based treatment in comparison to standard smoking counseling. It is expected that women who receive risk-based counseling will show better quit rates and a longer time to relapse than women who receive standard treatment.
Detailed description
The purpose of this treatment development study is to design and pilot test a smoking cessation intervention in which counseling sessions are tailored to individual smokers' perceived risks of quitting. The feasibility, acceptability, and efficacy of the novel treatment will be examined through a pilot study in which female smokers will be randomly assigned to receive either the tailored treatment or a standard treatment. It is expected that participants receiving the tailored treatment will show higher rates of smoking abstinence than participants receiving the standard smoking cessation treatment at the end of the 8-week treatment and at one month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tailored behavioral counseling | Experimental | Behavioral: Tailored treatmentThe focus of the first three sessions for participants receiving the tailored treatment will be their three most highly endorsed perceived risks of quitting. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's "Smoke Free and Living It" manual. The last 5 counseling sessions will be based on perceived risks of quitting. |
| Standard behavioral counseling | Active comparator | Behavioral: Standard TreatmentThe focus of the first three sessions for participants receiving the standard treatment will be the benefits of quitting smoking. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's "Smoke Free and Living It" manual. All participants will receive identical counseling sessions during week 4-8 based on material from the Mayo Clinic manual. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Between the ages of 18 and 64 years old
- Meet Diagnostic and Statistical Manual-IV (DSM-IV) criteria for nicotine dependence with Fagerström Test for Nicotine Dependence (FTND) score ≥4
- Smoke at least 15 cigarettes (3/4 pack) daily (averaged over 1 week, in the past 1 month) and have an expired breath carbon monoxide (CO) level ≥10
- At the time of initial evaluation, are motivated to quit smoking in the next 30 days.
- Have the capacity to give informed consent, and are English-speaking.
Key exclusion criteria (5 listed)
- Have a positive urine drug screen or urine pregnancy test at baseline evaluation
- Meet DSM-IV criteria for alcohol or other drug abuse or dependence in the previous 6 months
- Meet DSM-IV criteria for a current diagnosis of major depressive disorder, panic disorder or post-traumatic stress disorder
- Meet DSM-IV criteria for a current or past diagnosis of bipolar disorder or schizophrenia
- Are currently receiving treatment for nicotine dependence (e.g., nicotine replacement therapy, bupropion, chantix)
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 |
|---|---|---|
| Tailored treatment8 sessions of individual behavioral counseling. The first 3 sessions will be 45 minutes long and include 30 minutes tailored to the perceived risks of quitting most strongly held by each participant. The final 5 sessions will be 30 minutes long and include material from the Mayo Clinic's smoking cessation manual. | Behavioural | Tailored behavioral counseling |
| Standard Treatment8 sessions of individual behavioral counseling. The first 3 sessions will be 45 minutes long and include 30 minutes focused on the benefits of quitting smoking. The final 5 sessions will be 30 minutes long and include material from the Mayo Clinic's smoking cessation manual. | Behavioural | Standard behavioral counseling |
Primary outcome
Point-prevalence Smoking Abstinence Assessed at the End of the Trial and Measured by Self-report and Confirmed by Carbon Monoxide Levels
Time frame: Up to 8 weeks
point-prevalence smoking abstinence assessed at the end of the trial and measured by self-report (no smoking reported in the previous 7 days) and confirmed by carbon monoxide levels (CO levels < 5ppm)
2 secondary outcomes
Point-prevalence Smoking Abstinence Four Weeks After the End of the Trial Assessed by Self-report and Carbon Monoxide Levels
Time frame: 12 weeks
Change in Smoking From Baseline to the Followup Assessment (Week 12)
Time frame: Week 0 (baseline), Week 12 (one month followup)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2020.
- 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.
Andrea H. Weinberger, Ph.D. 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 Phase 1 study testing Tailored treatment and Standard Treatment in people with Nicotine Dependence, 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 5 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 20 Apr 2020. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jun 2013). 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?
Point-prevalence Smoking Abstinence Assessed at the End of the Trial and Measured by Self-report and Confirmed by Carbon Monoxide Levels (time frame: Up to 8 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 20 Apr 2020.