Smoking CessationNCT02192762
Withdrawal Exposure With Withdrawal Regulation Training for Smoking Cessation
A study testing Withdrawal regulation training and Relaxation training in people with Smoking Cessation, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This is a pilot study of a withdrawal regulation training program compared to relaxation training for individuals that are interested in smoking cessation. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Withdrawal regulation training and Relaxation training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Dec 2014
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women at least 19 years of age
- Reports smoking at least 10 cigarettes per day
- Must have expired breath carbon monoxide reading of at least eight parts per million
- Report the intention to quit smoking
- Reside in the Birmingham area with no plan to relocate outside of the area in the next six months
- Have access to a telephone for scheduling follow up assessments
Who cannot join
- Inability to speak English
- Presence of a condition that contraindicates use of transdermal nicotine patch (i.e. angina pectoris, arrhythmia, recent myocardial infarction, allergies to adhesives, serious skin disorders, and current pregnancy or breast feeding)
- Presence of conditions that might interfere with compliance with protocol or greatly complicate treatment (i.e. current alcohol or other substance dependence, dementia, psychosis, schizophrenia, bipolar disorder, suicidal or homicidal ideation, and any disease acutely life-threatening or so severe that the participant cannot comply with the protocol)
- Concurrent participation in a formal treatment program for smoking cessation
- Current use of any pharmacotherapy for smoking cessation
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: A Pilot Study of Withdrawal Regulation Training vs. Relaxation Training for Smoking Cessation (Withdrawal Exposure With Withdrawal Regulation Training for Smoking Cessation)
This is a pilot study of a withdrawal regulation training program compared to relaxation training for individuals that are interested in smoking cessation.
Read the detailed description
Participants will be recruited through newspaper and internet advertisements, advertisements on public transportation, community centers and community based organizations. All recruitment materials will contain a toll-free telephone number with 24-hour voice mail. The first contact with potential participant will be by telephone interview to assess for eligibility of participant. Participants who meet eligibility criteria will be invited to an orientation meeting where a breath carbon monoxide sample will be obtained. Women participant of childbearing potential will have a pregnancy test administered.
Participants will be randomized to one of two conditions: Early Withdrawal Exposure + Withdrawal Relaxation Training (E+WT) or Relaxation Training (RT) control. The E+WT condition will consist of the development, application, modification, and repeated practice of individualized withdrawal regulation for behavioral and cognitive strategies. the RT condition will control for the therapeutic contact received by those in the E+WT condition and will consist of the development, application, modification, and repeated practice of individualized relaxation techniques (e.g. breathing exercises, imagery).
- Conditions
- Smoking Cessation
- Being tested
- Withdrawal regulation training, Relaxation training
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Withdrawal regulation trainingBehavioural
Withdrawal coping skills
Relaxation trainingBehavioural
Relaxation skills instruction
| Study group | Role | What they receive |
|---|---|---|
| Withdrawal regulation training | Experimental | Withdrawal coping skills Receives: Behavioral: Withdrawal regulation training |
| Relaxation training | Active comparator | Relaxation skills instruction Receives: Behavioral: Relaxation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemically verified smoking abstinence
Smoking abstinence will be determined by self-report and confirmed via breath carbon monoxide (CO) analysis. Self-report of no smoking over the past 7 days (7-day point prevalence abstinence) and a CO value of less than 8 parts per million will be indicative of smoking abstinence. Self-report of any smoking over the past 7 days and/or CO values of 8 or greater will be indicative of cigarette use.
Measured: 2 months after end-of-treatment
Biochemically-verified smoking abstinence
Smoking abstinence will be determined by self-report and confirmed via breath carbon monoxide (CO) analysis. Self-report of no smoking over the past 7 days (7-day point prevalence abstinence) and a CO value of less than 8 parts per million will be indicative of smoking abstinence. Self-report of any smoking over the past 7 days and/or CO values of 8 or greater will be indicative of cigarette use.
Measured: 3 months after end-of-treatment
Secondary outcomes (2)
Withdrawal symptoms
Withdrawal symptoms will be measured via self-report with the Wisconsin Smoking Withdrawal Scale (WSWS), a reliable and valid instrument of smoking withdrawal symptomatology.
Measured: 2 months after end-of-treatment
Withdrawal symptoms
Withdrawal symptoms will be measured via self-report with the Wisconsin Smoking Withdrawal Scale (WSWS), a reliable and valid instrument of smoking withdrawal symptomatology.
Measured: 3 months after end-of-treament
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2014 (estimated)
- Study startJul 2011
- Primary completionDec 2014
- Study completionDec 2014
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.
- More trials run by University of Alabama at BirminghamThe 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Hendricks, University of Alabama at Birmingham
- Investigators
- Peter S Hendricks, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02192762
- Sponsor's protocol ID
- F110601002
- Status last verified
- Dec 2021
- First submitted
- 10 Apr 2014
- Last updated
- 13 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Withdrawal Regulation Training vs. Relaxation Training for Smoking Cessation (Withdrawal Exposure With Withdrawal Regulation Training for Smoking Cessation)
- ClinicalTrials.gov ID
- NCT02192762
- Acronym / sponsor ID
- F110601002
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 17 Jul 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.
This is a pilot study of a withdrawal regulation training program compared to relaxation training for individuals that are interested in smoking cessation.
Detailed description
Participants will be recruited through newspaper and internet advertisements, advertisements on public transportation, community centers and community based organizations. All recruitment materials will contain a toll-free telephone number with 24-hour voice mail. The first contact with potential participant will be by telephone interview to assess for eligibility of participant. Participants who meet eligibility criteria will be invited to an orientation meeting where a breath carbon monoxide sample will be obtained. Women participant of childbearing potential will have a pregnancy test administered.
Participants will be randomized to one of two conditions: Early Withdrawal Exposure + Withdrawal Relaxation Training (E+WT) or Relaxation Training (RT) control. The E+WT condition will consist of the development, application, modification, and repeated practice of individualized withdrawal regulation for behavioral and cognitive strategies. the RT condition will control for the therapeutic contact received by those in the E+WT condition and will consist of the development, application, modification, and repeated practice of individualized relaxation techniques (e.g. breathing exercises, imagery).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Withdrawal regulation training | Experimental | Behavioral: Withdrawal regulation trainingWithdrawal coping skills |
| Relaxation training | Active comparator | Behavioral: Relaxation trainingRelaxation skills instruction |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Men and women at least 19 years of age
- Reports smoking at least 10 cigarettes per day
- Must have expired breath carbon monoxide reading of at least eight parts per million
- Report the intention to quit smoking
- Reside in the Birmingham area with no plan to relocate outside of the area in the next six months
Key exclusion criteria (5 listed)
- Inability to speak English
- Presence of a condition that contraindicates use of transdermal nicotine patch (i.e. angina pectoris, arrhythmia, recent myocardial infarction, allergies to adhesives, serious skin disorders, and current pregnancy or breast feeding)
- Presence of conditions that might interfere with compliance with protocol or greatly complicate treatment (i.e. current alcohol or other substance dependence, dementia, psychosis, schizophrenia, bipolar disorder, suicidal or homicidal ideation, and any disease acutely life-threatening or so severe that the participant cannot comply with the protocol)
- Concurrent participation in a formal treatment program for smoking cessation
- Current use of any pharmacotherapy for smoking cessation
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 |
|---|---|---|
| Withdrawal regulation trainingWithdrawal coping skills | Behavioural | Withdrawal regulation training |
| Relaxation trainingRelaxation skills instruction | Behavioural | Relaxation training |
Primary outcome
Biochemically verified smoking abstinence
Time frame: 2 months after end-of-treatment
Smoking abstinence will be determined by self-report and confirmed via breath carbon monoxide (CO) analysis. Self-report of no smoking over the past 7 days (7-day point prevalence abstinence) and a CO value of less than 8 parts per million will be indicative of smoking abstinence. Self-report of any smoking over the past 7 days and/or CO values of 8 or greater will be indicative of cigarette use.
Biochemically-verified smoking abstinence
Time frame: 3 months after end-of-treatment
Smoking abstinence will be determined by self-report and confirmed via breath carbon monoxide (CO) analysis. Self-report of no smoking over the past 7 days (7-day point prevalence abstinence) and a CO value of less than 8 parts per million will be indicative of smoking abstinence. Self-report of any smoking over the past 7 days and/or CO values of 8 or greater will be indicative of cigarette use.
2 secondary outcomes
Withdrawal symptoms
Time frame: 2 months after end-of-treatment
Withdrawal symptoms
Time frame: 3 months after end-of-treament
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 13 Jan 2022.
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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.
Peter S Hendricks, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Withdrawal regulation training and Relaxation training in people with Smoking Cessation, run by University of Alabama at Birmingham 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 6 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 13 Jan 2022. 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?
Biochemically verified smoking abstinence (time frame: 2 months after end-of-treatment). The study lists 2 primary outcomes in all. 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 13 Jan 2022.