Tobacco DependenceNCT01423578
Effects of Yoga and Cardiovascular Exercise on Smoking Motivation
A study testing Hatha Yoga (HY), Cardiovascular Exercise (CE) and Smoking Cessation Counseling in people with Tobacco Dependence, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
The overall purpose of this pilot study is to examine effects of Hatha yoga and cardiovascular exercise on craving, mood, cue reactivity, and smoking behavior. Our preliminary study indicated that a single session of either form of activity intervention improved mood, and the yoga intervention appeared to decrease… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Dependence
- What is being tested?
- Hatha Yoga (HY), Cardiovascular Exercise (CE) 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
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Aug 2007to 20 Jun 2017
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Smoke at least 10 cigarettes per day
- Smoked regularly at least 2 years
- Carbon monoxide reading at least 8 ppm
- Interest in quitting smoking
- Able to read and understand the consent form and questionnaires
- Not currently practicing yoga
Who cannot join
- Current Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) (American Psychiatric Association, 1994) psychosis
- Major depressive episode, manic episode, or panic disorder
- Current DSM-IV psychoactive substance dependence or use
- Current medication use that might affect physiological responses
- Current use of bupropion, varenicline, or nicotine-containing products other than cigarettes
- Significant health problems that might compromise physiological data collection or be contraindicated for moderate physical exercise or yoga
- Significant hearing or visual impairment; pregnant as determined by urine human chorionic gonadotropin (hCG) test or nursing females
- Body mass index (BMI) 35 or greater
Trial locations and contacts
1 site in 1 country.
United States1 site
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
The overall purpose of this pilot study is to examine effects of Hatha yoga and cardiovascular exercise on craving, mood, cue reactivity, and smoking behavior. Our preliminary study indicated that a single session of either form of activity intervention improved mood, and the yoga intervention appeared to decrease cravings to smoke. The proposed study will extend this preliminary research in several ways.
Read the detailed description
First, the investigators will expand the exercise-based interventions from one to three sessions, which will more closely resemble how these interventions may be used in the context of smoking cessation. Second, the investigators will recruit smokers who are motivated to quit smoking, further increasing the clinical relevance of the research. Finally, the investigators will examine the effects of the interventions on actual smoking behavior within and outside of the laboratory setting. This may appropriately be considered a "proof of concept" study, as the investigators will not be powered to detect treatment outcome (smoking cessation) differences, nor are the interventions designed to maximize clinical smoking cessation outcomes.
Participants will be randomized to receive 3-sessions of yoga instruction, 3-sessions of cardiovascular exercise, or to a no activity control group. Sessions will be scheduled to occur approximately 7 days apart, with a minimum of 4 between sessions. Mood and craving will be assessed before and after each session, and smoking behavior will be assessed following each session. Finally, a detailed cue reactivity assessment will be conducted prior to the first session and following the last session. Analyses will examine intervention effects on craving, mood, cue reactivity, and smoking behavior. In addition, the investigators will examine several potential mediators and moderators of intervention effects on smoking behavior. Finally, the investigators will continue to examine the feasibility and potential acceptability of each active intervention, to assist in developing future clinical applications of these techniques in the context of smoking cessation.
- Conditions
- Tobacco Dependence
- Being tested
- Hatha Yoga (HY), Cardiovascular Exercise (CE), Smoking Cessation Counseling
- Keywords
- craving, mood, cue reactivity, smoking behavior, quit smoking, prevention, Hatha yoga, cardiovascular exercise
- 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.
Hatha Yoga (HY)Behavioural
Also called yoga
3 Sessions of yoga instruction
Cardiovascular Exercise (CE)Behavioural
Also called exercise
3 sessions of cardiovascular exercise
Smoking Cessation CounselingBehavioural
Also called control group
4 smoking cessation counseling visits.
| Study group | Role | What they receive |
|---|---|---|
| Hatha Yoga (HY) | Active comparator | Exercise and Smoking Cessation Counseling Receives: Behavioral: Hatha Yoga (HY); Behavioral: Smoking Cessation Counseling |
| Cardiovascular Exercise (CE) | Experimental | Exercise and Smoking Cessation Counseling Receives: Behavioral: Cardiovascular Exercise (CE); Behavioral: Smoking Cessation Counseling |
| Smoking Cessation Counseling Only | Other | Control Group - Smoking Cessation Counseling Receives: Behavioral: Smoking Cessation Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Participants Reporting Post Intervention Effects
Intervention effects on measures of craving, mood, cue reactivity, and smoking behavior will be analyzed with mixed-design analysis of variance (ANOVA), with Intervention as the between-group factor (HY vs. CE vs. NA), and Time as a within-subject factor (pre vs. post-intervention). Analyses for cue reactivity variables will include the additional within-subject factor of Cue Type (smoking vs. neutral), and analyses for craving and mood self-report will include the additional within-subject factor of Session (1 vs. 2 vs. 3).
Measured: Average of 6 Months
Secondary outcomes (1)
Number of Participants Reporting Behavior Changes Post Intervention
In order to determine whether intervention effects on smoking behavior are mediated by changes in craving, mood, and/or cue reactivity, we will conduct Sobel tests (e.g., Preacher \& Leonardelli, 2001), supplemented by mediation analyses using methods of Baron \& Kenny (1986).
Measured: Average of 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2011 (estimated)
- Study start21 Aug 2007
- Primary completion2 May 2011
- Study completion20 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco DependenceStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David J. Drobes, Ph.D., Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01423578
- Sponsor's protocol ID
- MCC-15245
- Status last verified
- Jun 2017
- First submitted
- 24 Aug 2011
- Last updated
- 26 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Yoga and Cardiovascular Exercise on Smoking Motivation
- ClinicalTrials.gov ID
- NCT01423578
- Acronym / sponsor ID
- MCC-15245
- Conditions
- Tobacco Dependence
- Keywords
- craving, mood, cue reactivity, smoking behavior, quit smoking, prevention, Hatha yoga, cardiovascular exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Study start
- 21 Aug 2007 (actual)
- Primary completion
- 2 May 2011 (actual)
- Study completion
- 20 Jun 2017 (actual)
- First posted
- 26 Aug 2011 (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 overall purpose of this pilot study is to examine effects of Hatha yoga and cardiovascular exercise on craving, mood, cue reactivity, and smoking behavior. Our preliminary study indicated that a single session of either form of activity intervention improved mood, and the yoga intervention appeared to decrease cravings to smoke. The proposed study will extend this preliminary research in several ways.
Detailed description
First, the investigators will expand the exercise-based interventions from one to three sessions, which will more closely resemble how these interventions may be used in the context of smoking cessation. Second, the investigators will recruit smokers who are motivated to quit smoking, further increasing the clinical relevance of the research. Finally, the investigators will examine the effects of the interventions on actual smoking behavior within and outside of the laboratory setting. This may appropriately be considered a "proof of concept" study, as the investigators will not be powered to detect treatment outcome (smoking cessation) differences, nor are the interventions designed to maximize clinical smoking cessation outcomes.
Participants will be randomized to receive 3-sessions of yoga instruction, 3-sessions of cardiovascular exercise, or to a no activity control group. Sessions will be scheduled to occur approximately 7 days apart, with a minimum of 4 between sessions. Mood and craving will be assessed before and after each session, and smoking behavior will be assessed following each session. Finally, a detailed cue reactivity assessment will be conducted prior to the first session and following the last session. Analyses will examine intervention effects on craving, mood, cue reactivity, and smoking behavior. In addition, the investigators will examine several potential mediators and moderators of intervention effects on smoking behavior. Finally, the investigators will continue to examine the feasibility and potential acceptability of each active intervention, to assist in developing future clinical applications of these techniques in the context of smoking cessation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hatha Yoga (HY) | Active comparator | Behavioral: Hatha Yoga (HY), Behavioral: Smoking Cessation CounselingExercise and Smoking Cessation Counseling |
| Cardiovascular Exercise (CE) | Experimental | Behavioral: Cardiovascular Exercise (CE), Behavioral: Smoking Cessation CounselingExercise and Smoking Cessation Counseling |
| Smoking Cessation Counseling Only | Other | Behavioral: Smoking Cessation CounselingControl Group - Smoking Cessation Counseling |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Smoke at least 10 cigarettes per day
- Smoked regularly at least 2 years
- Carbon monoxide reading at least 8 ppm
- Interest in quitting smoking
- Able to read and understand the consent form and questionnaires
Key exclusion criteria (8 listed)
- Current Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) (American Psychiatric Association, 1994) psychosis
- Major depressive episode, manic episode, or panic disorder
- Current DSM-IV psychoactive substance dependence or use
- Current medication use that might affect physiological responses
- Current use of bupropion, varenicline, or nicotine-containing products other than cigarettes
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 |
|---|---|---|
| Hatha Yoga (HY)Also: yoga3 Sessions of yoga instruction | Behavioural | Hatha Yoga (HY) |
| Cardiovascular Exercise (CE)Also: exercise3 sessions of cardiovascular exercise | Behavioural | Cardiovascular Exercise (CE) |
| Smoking Cessation CounselingAlso: control group4 smoking cessation counseling visits. | Behavioural | Cardiovascular Exercise (CE), Hatha Yoga (HY), Smoking Cessation Counseling Only |
Primary outcome
The Number of Participants Reporting Post Intervention Effects
Time frame: Average of 6 Months
Intervention effects on measures of craving, mood, cue reactivity, and smoking behavior will be analyzed with mixed-design analysis of variance (ANOVA), with Intervention as the between-group factor (HY vs. CE vs. NA), and Time as a within-subject factor (pre vs. post-intervention). Analyses for cue reactivity variables will include the additional within-subject factor of Cue Type (smoking vs. neutral), and analyses for craving and mood self-report will include the additional within-subject factor of Session (1 vs. 2 vs. 3).
1 secondary outcome
Number of Participants Reporting Behavior Changes Post Intervention
Time frame: Average of 6 Months
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 26 Jun 2017.
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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.
David J. Drobes, Ph.D. principal investigator
H. Lee Moffitt Cancer Center and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hatha Yoga (HY), Cardiovascular Exercise (CE) and Smoking Cessation Counseling in people with Tobacco Dependence, run by H. Lee Moffitt Cancer Center and Research Institute 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 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 26 Jun 2017. 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?
The Number of Participants Reporting Post Intervention Effects (time frame: Average of 6 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 26 Jun 2017.