YogaNCT02181179
Examining Yoga's Effects on Smoking
A study testing Yoga in people with Yoga and Waitlist, run by Jasper A. Smits at 1 site in United States.
Trial summary
The primary aim of this research study is to examine the effects of an 8-week yoga program on aspects related to nicotine dependence, stress, and coping during a smoking quit attempt. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- What is being tested?
- Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Jul 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female only patients ages 18-65 capable of providing informed consent
- Daily smoker for at least one year.
- Currently smoke an average of at least 10 cigarettes per day.
- Sedentary as defined by moderate-intensity exercise less than 2 days/wk for at least 30 minutes each
- Written physician approval/medical clearance to participate in an exercise/yoga protocol.
- -Report motivation to quit smoking of at least 5 on a 10-point Likert-type scale - -Express interest in making a serious, unassisted quit attempt in the next month-
- Have not decreased number of cigarettes smoked in the past 6 months
Who cannot join
- Use of other tobacco products
- Severe obesity (BMI ≥ 40)
- Currently pregnant or plans to become pregnant
- Diagnosis of a schizophrenia or bipolar-spectrum disorder
- Currently suicidal or suicide high-risk or severe depression
- Use of corticosteroid medications
- Change in medication doses for past 6-months for psychotropic drugs
- Receiving concurrent psychotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examining Yoga's Effects on Aspects Related to Stress and Smoking Behavior
The primary aim of this research study is to examine the effects of an 8-week yoga program on aspects related to nicotine dependence, stress, and coping during a smoking quit attempt.
Guided by initial studies reporting on the effects of yoga on putative mediators of smoking relapse (i.e., cortisol, distress intolerance, withdrawal symptoms), the proposed experiment examines the effects of an 8-week yoga practice on nicotine withdrawal intensity by way of aiding withdrawal characteristics predictive of smoking relapse. The long-term objectives of the proposed line of research are to: (1) inform theoretical models of nicotine withdrawal, (2) guide the development of effective alternative interventions for smokers susceptible to relapse during the critical withdrawal period (i.e., smokers low in distress tolerance), and (3) to help guide behavioral strategies for treating substance addictions broadly.
Read the detailed description
As the leading cause of preventable death in the US and a major cause for chronic disease/mortality worldwide, smoking represents a major public health issue in need of effective interventions to reduce its burden. The development of such strategies is best directed by basic research on the biobehavioral processes underlying smoking maintenance and relapse. A major predictor of cessation failure is nicotine withdrawal, especially among individuals low in distress tolerance (DT).
Reducing nicotine withdrawal-related distress and relapse in low DT smokers may require the regulation of certain hormones involved in the hypothalamic pituitary axis (HPA-axis) (i.e., the human stress response). Regular practice of yoga, a mindfulness-based form of physical activity, emerges as a promising strategy for regulating the HPA-axis, decreasing withdrawal symptoms, and increasing DT, thus promoting smoking cessation success.
We will randomly assign 50 smokers (≥10 cigarettes daily) low in DT to either an 8-week yoga intervention [YOGA] or a waitlist control [WL] prior to undergoing a self-guided quit attempt. We hypothesize participants assigned to the yoga condition (relative to waitlist) will differ on various outcomes assessed throughout the intervention (e.g., quit status, negative affective states, stress, hormonal changes, withdrawal) and, quit day, and throughout the 2-week quit follow-up period.
More specifically, we hypothesize that certain typical maladaptive, during-withdrawal changes may be attenuated through YOGA. We also hope to obtain initial effect sizes of the advantage of yoga compared to waitlist for point-prevalent abstinence at two weeks following an unaided quit attempt.
- Being tested
- Yoga
- Keywords
- yoga, exercise intervention, smoking, stress, mind-body, intervention
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaBehavioural
Also called Hatha yoga, vinyasa yoga
The yoga intervention will be an 8-week program involving two 60-minute sessions each week at a local studio with three locations in Austin. Participants will be instructed to take classes deemed within a moderate-to-vigorous intensity dose. Participants will also be encouraged both by the PI and yoga instructors to complete the entire 60 minutes of yoga, urged to do only what is comfortable and not push themselves beyond their physical limits.
| Study group | Role | What they receive |
|---|---|---|
| Yoga | Active comparator | This will involve participating in at least two 60-minute Vinyasa yoga sessions each week for eight weeks (weeks 1-8). This will begin the week following a baseline laboratory appointment. These sessions will be conducted at a local Austin studio that has numerous locations in the area. Receives: Behavioral: Yoga |
| Waitlist | No intervention | If randomized to this group, participants will complete weekly assessments only and not yoga during their time in the study. Following full completion of the study (i.e., after week 10), participants will be compensated with a voucher for 2 free months of yoga. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Objective Stress through Hormonal Biomarkers (Hair & Salivary Cortisol)
we will collect biological samples of hair and saliva to assess changes in biomarkers in response to yoga, and as a potential mechanism by which yoga may aid in smoking cessation. Saliva samples will be collected with Salivettes (Sarstedt, Rommelsdorf, Germany), plastic vials with cotton dental rolls inside. Participants will complete 2 Salivettes at each of three separate 12-hr collection periods. participants will provide two hair strand samples cut by trained personnel (Gerber et al., 2012; Suave et al., 2007; Meyer \& Novak, 2012). Hair strands are cut close to the scalp from the posterior vertex of the head using surgical scissors.
Measured: Collected at pre-and-post intervention (Baseline and Quit day, Week 9)
Minnesota Nicotine Withdrawal Scale-Revised
MNWS-R (Hughes \& Hatsukami, 1986) is a validated 15-item self-report measure of withdrawal severity rated on a 5 point Likert scale (0 "none" to 4 "severe") that will establish level of nicotine withdrawal as a major outcome assessed between groups during quit period.
Measured: post-yoga Week 9 on Quit day and week 10 follow-up
Secondary outcomes (11)
Self reported anxiety sensitivity - Anxiety Sensitivity Scale (ASI).
The 16-item ASI will be employed to assess sensitivity to, and discomfort with, physical anxiety sensations. The ASI (Reiss et al., 1986) as a screening criterion (ASI≥ 20 as indicative of elevated AS) and an outcome measure. The ASI has good internal consistency, test-retest reliability, and excellent convergent validity with other established measures. For the purpose eligibility assessment, this measure will be completed during the Online Prescreen. This measure will also be assessed weekly as a primary outcome assessed between groups.
Measured: Weekly from pre-to-post intervention (screen, Baseline, weeks 1-10)
carbon monoxide (CO)
Participants will complete carbon monoxide (CO) analysis of breath sample (≥8ppm cutoff; Jarvis et al., 1987) to determine smoking status during ad-libitum phases and to assess smoking quit status during the quit period.
Measured: Screen, week 0 (baseline), week 9 Quit day, & week 10 follow up
Smoking point-prevalence - timeline follow back calendar
Participants will complete the full timeline follow back calendar (TLFB; past-week) to assess daily point-prevalence of cigarettes both as a screening tool (reflecting ≥ 10 cigarettes/day on average for the past year; and throughout the study period. point prevalence during quit period will be examined between groups and verified with biochemical measurement of lung carbon monoxide (CO)
Measured: Weeks Screen, 0 (baseline), 1-8 (intervention), 9-10 (quit period)
Five Facet Mindfulness Questionnaire (FFMQ).
The FFMQ (Baer et al., 2006) is a 39-item self-report measure of mindfulness components: observing, describing, acting with awareness, nonjudging of inner experience, and nonreactivity to inner experience. This will be given across intervention to assess changes in response to the mindfulness-based practice of yoga (i.e., with changes compared between groups).
Measured: Weekly from baseline to post-yoga (week 9)
Barratt Impulsiveness Scale (BIS) of Trait Impulsivity
BIS-15 (Spinella, 2007) is a 15-item self-report measure of 3 non-overlapping impulsivity components: non-planning, motor impulsivity, and attention impulsivity. As one of the most commonly used measures of impulsivity, it has demonstrated validity and reliability in neuropsychiatric and healthy populations. The 15-item short form of the BIS has shown to retain its 3-factor structure when subject to factor analysis and maintained good reliability and validity (Spinella 2007). screening tool (coupled with the ASI) to select individuals scoring above the community norm for impulsivity (Mean score ≥ 32.6 out of 54), as this smoking population may be especially at risk for reactivity to withdrawal symptoms/withdrawal related relapse.
Measured: Eligibility Screen
Balloon Analogue Risk Task (BART).
BART is a laboratory-based behavioral measure of risk taking, evidencing sound experimental properties. It has been shown to predict risk-related constructs (e.g., impulsivity, sensation seeking) as well as self-reported real-world risk behaviors in adults and adolescents (Lejuez et al., 2002). Riskiness on the BART has been correlated with occurrence of addictive, health, and safety risk behaviors, indicating that the BART may be a useful clinical assessment tool. Importantly, as smokers have demonstrated greater total riskiness and sensation seeking on the BART, we will administer the task at pre-and-post intervention as a secondary predictor of smoking outcomes in our trial, possibly indicative of greater difficulty quitting related to impulsivity (which may also be aided with yoga, and thus, differences in behavior will be compared between groups).
Measured: Pre-to-post (at eligibility screen & week 9 visit).
Computerized Delay Discounting Task (DDT).
The Delay Discounting choice task is a valid and reliable computer adaptive procedure developed for the purpose of studying choice behavior and delayed reward (Richards et al., 1999). The program asks the participant to decide between a higher amount of money (e.g., $10) to be received after one of the different delay periods (e.g., 1 day, 1 week) or a smaller amount of money (e.g. $1) to be received immediately. Because scores on DDT appear to be related to smoking status and level of nicotine dependence (Sweitzer et al., 2008) this measure was included both as a secondary screening predictor of smoking cessation success, and to observe possible pre-to-post changes afforded by yoga. Changes in behavior on this task will compared between groups.
Measured: Pre-to-post (eligibility screen & week 9 visit)
Distress Tolerance Scale (DTS).
The DTS (Simons \& Gaher, 2005), a 15-item self-report measure of physical and psychological distress tolerance, will assess changes in DT; it consists of a 5-point Likert scale with possible ratings ranging from strongly agree to strongly disagree. DTS has high internal consistency (alpha=.82). This will serve as a secondary measurement of distress tolerance, accompanying the ASI, and assessed through between-group changes.
Measured: Weekly; Baseline (week 0) through week 10 follow up
Mood and Anxiety Symptom Questionnaire (MASQ).
The MASQ is a self-report measure derived from the tripartite model (Watson et al., 1995). It includes 62 items rated on a scale ranging from 1 (not at all) to 5 (extremely) focusing on how much an individual has experienced specific affect symptoms in the past week. Four subscales include: Anxious Arousal, Anhedonic Depression, General Distress: Anxious Symptoms, and General Distress: Depressive symptoms. We will use the MASQ to assess affective changes in response to 12-hour withdrawal. The MASQ has been employed in previous smoking cessation work (e.g., Zvolensky et al., 2009), and therefore, beyond being psychometrically sound, offers a higher degree of comparability across research. Ratings will be compared between-groups
Measured: Quit day week 9
Fagerstrom Test of Nicotine Dependence (FTND).
The FTND (Heatherton, Kozlowski, Frecker, \& Fagerstrom, 1991) has shown good internal consistency, a single dimension factor structure, and positive relationships with degree of nicotine intake. Dependence status will be assessed at baseline, mid, and post-treatment. This measure will serve to quantify nicotine dependence, which will be used as a covariate in the primary analyses.
Measured: Week 0, 6, 9
Beck Depression Inventory (BDI).
The BDI (Beck, Mendelson, Mock, \& Erbaugh, 1961) is a widely used 21-item, self-report inventory designed to measure severity of depressive symptoms. Individuals will only be eligible with scores of ≤30 on the BDI (scores ≥30 indicate severe depression). The BDI will also be administered throughout the protocol to assess changes in depressive symptoms possibly affected through yoga.
Measured: Eligibility screen, weeks 0, 6, 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for YogaStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jasper A. Smits
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jasper A. Smits, University of Texas at Austin
- Investigators
- Johnna Medina, M.A., Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02181179
- Sponsor's protocol ID
- 2014040107
- Status last verified
- Oct 2017
- First submitted
- 1 Jul 2014
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Yoga's Effects on Aspects Related to Stress and Smoking Behavior
- ClinicalTrials.gov ID
- NCT02181179
- Acronym / sponsor ID
- 2014040107
- Keywords
- yoga, exercise intervention, smoking, stress, mind-body, intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Jasper A. SmitsUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 3 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.
The primary aim of this research study is to examine the effects of an 8-week yoga program on aspects related to nicotine dependence, stress, and coping during a smoking quit attempt.
Guided by initial studies reporting on the effects of yoga on putative mediators of smoking relapse (i.e., cortisol, distress intolerance, withdrawal symptoms), the proposed experiment examines the effects of an 8-week yoga practice on nicotine withdrawal intensity by way of aiding withdrawal characteristics predictive of smoking relapse. The long-term objectives of the proposed line of research are to: (1) inform theoretical models of nicotine withdrawal, (2) guide the development of effective alternative interventions for smokers susceptible to relapse during the critical withdrawal period (i.e., smokers low in distress tolerance), and (3) to help guide behavioral strategies for treating substance addictions broadly.
Detailed description
As the leading cause of preventable death in the US and a major cause for chronic disease/mortality worldwide, smoking represents a major public health issue in need of effective interventions to reduce its burden. The development of such strategies is best directed by basic research on the biobehavioral processes underlying smoking maintenance and relapse. A major predictor of cessation failure is nicotine withdrawal, especially among individuals low in distress tolerance (DT).
Reducing nicotine withdrawal-related distress and relapse in low DT smokers may require the regulation of certain hormones involved in the hypothalamic pituitary axis (HPA-axis) (i.e., the human stress response). Regular practice of yoga, a mindfulness-based form of physical activity, emerges as a promising strategy for regulating the HPA-axis, decreasing withdrawal symptoms, and increasing DT, thus promoting smoking cessation success.
We will randomly assign 50 smokers (≥10 cigarettes daily) low in DT to either an 8-week yoga intervention [YOGA] or a waitlist control [WL] prior to undergoing a self-guided quit attempt. We hypothesize participants assigned to the yoga condition (relative to waitlist) will differ on various outcomes assessed throughout the intervention (e.g., quit status, negative affective states, stress, hormonal changes, withdrawal) and, quit day, and throughout the 2-week quit follow-up period.
More specifically, we hypothesize that certain typical maladaptive, during-withdrawal changes may be attenuated through YOGA. We also hope to obtain initial effect sizes of the advantage of yoga compared to waitlist for point-prevalent abstinence at two weeks following an unaided quit attempt.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga | Active comparator | Behavioral: YogaThis will involve participating in at least two 60-minute Vinyasa yoga sessions each week for eight weeks (weeks 1-8). This will begin the week following a baseline laboratory appointment. These sessions will be conducted at a local Austin studio that has numerous locations in the area. |
| Waitlist | No intervention | –If randomized to this group, participants will complete weekly assessments only and not yoga during their time in the study. Following full completion of the study (i.e., after week 10), participants will be compensated with a voucher for 2 free months of yoga. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female only patients ages 18-65 capable of providing informed consent
- Daily smoker for at least one year.
- Currently smoke an average of at least 10 cigarettes per day.
- Sedentary as defined by moderate-intensity exercise less than 2 days/wk for at least 30 minutes each
- Written physician approval/medical clearance to participate in an exercise/yoga protocol.
Key exclusion criteria (8 listed)
- Use of other tobacco products
- Severe obesity (BMI ≥ 40)
- Currently pregnant or plans to become pregnant
- Diagnosis of a schizophrenia or bipolar-spectrum disorder
- Currently suicidal or suicide high-risk or severe depression
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 |
|---|---|---|
| YogaAlso: Hatha yoga, vinyasa yogaThe yoga intervention will be an 8-week program involving two 60-minute sessions each week at a local studio with three locations in Austin. Participants will be instructed to take classes deemed within a moderate-to-vigorous intensity dose. Participants will also be encouraged both by the PI and yoga instructors to complete the entire 60 minutes of yoga, urged to do only what is comfortable and not push themselves beyond their physical limits. | Behavioural | Yoga |
Primary outcome
Measurement of Objective Stress through Hormonal Biomarkers (Hair & Salivary Cortisol)
Time frame: Collected at pre-and-post intervention (Baseline and Quit day, Week 9)
we will collect biological samples of hair and saliva to assess changes in biomarkers in response to yoga, and as a potential mechanism by which yoga may aid in smoking cessation. Saliva samples will be collected with Salivettes (Sarstedt, Rommelsdorf, Germany), plastic vials with cotton dental rolls inside. Participants will complete 2 Salivettes at each of three separate 12-hr collection periods. participants will provide two hair strand samples cut by trained personnel (Gerber et al., 2012; Suave et al., 2007; Meyer \& Novak, 2012). Hair strands are cut close to the scalp from the posterior vertex of the head using surgical scissors.
Minnesota Nicotine Withdrawal Scale-Revised
Time frame: post-yoga Week 9 on Quit day and week 10 follow-up
MNWS-R (Hughes \& Hatsukami, 1986) is a validated 15-item self-report measure of withdrawal severity rated on a 5 point Likert scale (0 "none" to 4 "severe") that will establish level of nicotine withdrawal as a major outcome assessed between groups during quit period.
11 secondary outcomes
Self reported anxiety sensitivity - Anxiety Sensitivity Scale (ASI).
Time frame: Weekly from pre-to-post intervention (screen, Baseline, weeks 1-10)
carbon monoxide (CO)
Time frame: Screen, week 0 (baseline), week 9 Quit day, & week 10 follow up
Smoking point-prevalence - timeline follow back calendar
Time frame: Weeks Screen, 0 (baseline), 1-8 (intervention), 9-10 (quit period)
Five Facet Mindfulness Questionnaire (FFMQ).
Time frame: Weekly from baseline to post-yoga (week 9)
Barratt Impulsiveness Scale (BIS) of Trait Impulsivity
Time frame: Eligibility Screen
Balloon Analogue Risk Task (BART).
Time frame: Pre-to-post (at eligibility screen & week 9 visit).
Computerized Delay Discounting Task (DDT).
Time frame: Pre-to-post (eligibility screen & week 9 visit)
Distress Tolerance Scale (DTS).
Time frame: Weekly; Baseline (week 0) through week 10 follow up
Mood and Anxiety Symptom Questionnaire (MASQ).
Time frame: Quit day week 9
Fagerstrom Test of Nicotine Dependence (FTND).
Time frame: Week 0, 6, 9
Beck Depression Inventory (BDI).
Time frame: Eligibility screen, weeks 0, 6, 9
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 15 Jun 2026.
- Anxiety and Health Behaviors LabLink provided by the sponsor.
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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.
Johnna Medina, M.A. principal investigator
University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga in people with Yoga and Waitlist, run by Jasper A. Smits 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 7 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 15 Jun 2026. 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?
Measurement of Objective Stress through Hormonal Biomarkers (Hair & Salivary Cortisol) (time frame: Collected at pre-and-post intervention (Baseline and Quit day, Week 9)). 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 15 Jun 2026.