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Tobacco DependenceNCT01809678

Yoga as a Complementary Therapy for Smoking Cessation

A study testing Smoking Cessation, Yoga and Wellness in people with Tobacco Dependence, run by The Miriam Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study examines the efficacy of yoga as a complementary therapy for smoking cessation Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Tobacco Dependence
What is being tested?
Smoking Cessation, Yoga and Wellness
Could I receive a placebo?
No, everyone receives an active treatment
How many people
255 participants
Where
1 siteUnited States
Study dates
Jul 2012to 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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age 18 years or older (physician clearance for age > 65)
  • English-speaking
  • Currently Healthy
  • Smoking smoked 5 or more cigarettes/day
  • Must accept randomization procedure
  • BMI< 40
  • Will be Living in RI/MA/CT for next year

Who cannot join

  • Participated in any Yoga, Tai Chi, Qi Gong or Mindfulness-based therapy program twice in the past month or 10 times within the past year
  • MD refused consent or Unable to obtain MD consent
  • Unable to attend program due to work or home schedule
  • Currently using medications or in active treatment to quit smoking
  • Currently or planned participation in research or treatment programs that would interfere with this study
  • Presence of health conditions that would make participation in yoga difficult or dangerous
Show all 23Show fewer
  • Medical Exclusion Criteria
  • Cardiovascular disease
  • Stroke/TIA
  • Chest pain with physical activity
  • Current or recent (< 6 months) cancer treatment
  • Uncontrolled Hypertension
  • Untreated major depression or hospitalization < six months
  • Bone joint problems
  • Liver or Kidney Disease
  • Fainting within the past year
  • History of seizures
  • Balance condition that interferes with ability to exercise
  • Respiratory Condition - COPD (e.g., emphysema requiring oxygen)
  • Liver Disease
  • Kidney Disease
  • Other medical condition that would interfere with ability to exercise
  • Hypothyroid (not on stable medication for 3 months)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The Miriam Hospital

    Providence, Rhode Island, 02906

Other trials in United States

About this study

Official title: Efficacy of Yoga as a Complementary Therapy for Smoking Cessation

This study examines the efficacy of yoga as a complementary therapy for smoking cessation

Read the detailed description

Despite the existence of effective medications for smoking cessation, approximately 50-80% of smokers attempt to quit without using pharmacotherapy. Efforts to encourage medication use during cessation attempts have met with mixed success. Many do not use medications because of concerns about side effects, contraindications that make medication use inappropriate, and individual preferences for chemical-free quit attempts. This leaves many smokers seeking an effective alternative to assist them in attempting to quit smoking. Each year, over 41% of smokers report failed attempts to quit smoking. Thus, effective non-pharmacological interventions to increase rates of successful cessation are greatly needed.

Our research, and the research of other investigators, has demonstrated that traditional (Western) exercise (e.g., brisk walking, bicycling) improves smokers' ability to successfully quit. Exercise may help smokers quit by reducing concerns regarding post-cessation weight gain, and by reducing nicotine withdrawal and enhancing mood. Recent research suggests that yoga is an acceptable and potentially effective alternative therapy for smoking cessation for several reasons: As a form of exercise, yoga shares many of the same properties as traditional (Western) aerobic exercise in that yoga has been shown to improve mood, physical fitness, weight control, self-image and quality of life in healthy and ill populations. Moreover, features of yoga, including a focus on breathing, mental concentration, meditation, stress reduction and enhanced mood are likely to have special relevance for smokers who are trying to quit. Thus, yoga may be particularly attractive as an alternative for individuals who either cannot use medications, or who choose not to use medications while quitting.

The proposed study will test the efficacy of Yoga as a complementary therapy for smoking cessation using a randomized, controlled study design. Adult smokers will be randomly assigned to either; 1) Yoga, or 2) an equal contact time Control group (CTL) given a health \& wellness program to control for contact time. All participants will be provided (separately by treatment group assignment) with the same cognitive-behavioral Smoking Cessation Counseling (SCC). Smoking abstinence will be measured at the end of treatment (week 8) and at 3, 6 and 12 months follow-up. We hypothesize that abstinence will be significantly higher in the SCC+Yoga group compared to SCC+CTL. We will also test theoretically posited mediators of intervention efficacy (e.g., perceived stress, cognitive/perceptual changes), examine the cost-efficacy of the yoga intervention, and examine the relationship between maintenance of yoga practice during the post-treatment period and smoking status. This study builds on our programmatic line of research developing innovative, theory-driven smoking cessation therapies.

Being tested
Smoking Cessation, Yoga, Wellness
Keywords
Smoking, Tobacco, Yoga
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.

  • Smoking CessationBehavioural

    Once weekly program of cognitive-behavioral therapy for smoking cessation

  • YogaBehavioural

    Twice weekly program of 1-hour Iyengar yoga classes

  • WellnessOther

    Twice weekly program of 1-hour wellness classes on a variety of health topics.

Study groups in NCT01809678
Study groupRoleWhat they receive
Smoking Cessation plus YogaExperimentalTwice weekly, 1-hour yoga classes delivered for 8 weeks combined with once-weekly, 1-hour cognitive-behavioral smoking cessation classes.
Receives: Behavioral: Smoking Cessation; Behavioral: Yoga
Smoking Cessation plus WellnessActive comparatorTwice-weekly, 1-hour Wellness classes given on a variety of health topics twice weekly to match schedule of the yoga classes, plus 1-hour per week of cognitive-behavioral smoking cessation
Receives: Behavioral: Smoking Cessation; Other: Wellness

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Smoking abstinence

    Abstinence from smoking at 1-year post treatment

    Measured: One year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2013 (estimated)
  2. Study startJul 2012
  3. Primary completionJul 2016
  4. Study completionJun 2017

Resources

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
Outcomes assessor
Enrolment
255 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01809678
Sponsor's protocol ID
R01AT006948
Status last verified
Jul 2021
First submitted
11 Mar 2013
Last updated
19 Jul 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • Thind H, Jennings E, Fava JL, Sillice MA, Becker BM, Hartman SJ, Bock BC. Differences between Men and Women Enrolling in Smoking Cessation Programs Using Yoga as a Complementary Therapy. J Yoga Phys Ther. 2016;6(3):245. doi: 10.4172/2157-7595.1000245. Epub 2016 Jun 15.

    PubMed 27683623

  • Bock BC, Rosen RK, Fava JL, Gaskins RB, Jennings E, Thind H, Carmody J, Dunsiger SI, Gidron N, Becker BM, Marcus BH. Testing the efficacy of yoga as a complementary therapy for smoking cessation: design and methods of the BreathEasy trial. Contemp Clin Trials. 2014 Jul;38(2):321-32. doi: 10.1016/j.cct.2014.06.003. Epub 2014 Jun 14.

    PubMed 24937018

  • Bock BC, Dunsiger SI, Rosen RK, Thind H, Jennings E, Fava JL, Becker BM, Carmody J, Marcus BH. Yoga as a Complementary Therapy for Smoking Cessation: Results From BreathEasy, a Randomized Clinical Trial. Nicotine Tob Res. 2019 Oct 26;21(11):1517-1523. doi: 10.1093/ntr/nty212.

    PubMed 30295912

  • Bock BC, Thind H, Dunsiger S, Fava JL, Jennings E, Becker BM, Marcus BH, Rosen RK, Sillice MA. Who Enrolls in a Quit Smoking Program with Yoga Therapy? Am J Health Behav. 2017 Nov 1;41(6):740-749. doi: 10.5993/AJHB.41.6.8.

    PubMed 29025502

  • Rosen RK, Thind H, Jennings E, Guthrie KM, Williams DM, Bock BC. "Smoking Does Not Go With Yoga:" A Qualitative Study of Women's Phenomenological Perceptions During Yoga and Smoking Cessation. Int J Yoga Therap. 2016 Jan;26(1):33-41. doi: 10.17761/1531-2054-26.1.33.

    PubMed 27797659

Questions about this trial

What is this clinical trial studying?

A study testing Smoking Cessation, Yoga and Wellness in people with Tobacco Dependence, run by The Miriam 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 7 inclusion and 23 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 19 Jul 2021. 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?

Smoking abstinence (time frame: One year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01809678, which also lists 5 linked publications.

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 19 Jul 2021.

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