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Yoga for Men Attempting Smoking Cessation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02055326
Recruitment Status : Completed
First Posted : February 5, 2014
Last Update Posted : February 5, 2014
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
The Miriam Hospital

Brief Summary:
The purpose of this pilot study is to examine the feasibility and preliminary efficacy of a quit-smoking program that combines behavioral therapy with either yoga, or a health & wellness program that serves as a contact control.

Condition or disease Intervention/treatment Phase
Smoking Cessation Behavioral: Cognitive Behavioral Therapy for Smoking Cessation Behavioral: Yoga Behavioral: Health & Wellness Not Applicable

Detailed Description:
Men enrolled in this pilot will be provided with 8 weeks of cognitive-behavioral therapy for smoking cessation and either 1) a twice-weekly program of yoga, or 2) a health & wellness program that serves as a control for number of contacts and subject burden between study conditions. Qualitative data from open ended surveys and interviews is used to supplement survey data to enhance the investigators understanding of study outcomes. Participant accrual and retention rates, acceptance of randomization, and compliance with study protocols will be examined along with perceptions and beliefs about yoga and its relationship to quitting smoking specifically, and health in general.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Complementary Treatments for Smoking Cessation
Study Start Date : September 2009
Actual Primary Completion Date : February 2011
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Yoga
One-hour sessions of twice weekly yoga for 8 weeks.
Behavioral: Cognitive Behavioral Therapy for Smoking Cessation
one hour weekly for 8 weeks. Cognitive behavioral therapy for smoking cessation

Behavioral: Yoga
One hour, twice weekly for 8 weeks of vinyasa yoga

Active Comparator: Health & Wellness
8 week program of health & wellness classes, materials and handouts. Topics included healthy eating, cancer prevention and cardiovascular disease prevention.
Behavioral: Cognitive Behavioral Therapy for Smoking Cessation
one hour weekly for 8 weeks. Cognitive behavioral therapy for smoking cessation

Behavioral: Health & Wellness
Lectures, handouts and printed materials on general health and wellness topics including healthy eating, cancer prevention and cardiovascular disease prevention.




Primary Outcome Measures :
  1. Smoking abstinence [ Time Frame: 7 days ]
    7-day point prevalence abstinence was measured at 8 weeks, 3 and 6 months follow up



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • male
  • age 18 -65
  • daily smoker, 5 or more cigarettes/day
  • generally healthy
  • able to exercise safely

Exclusion Criteria:

  • female
  • hypertension
  • current or recent history of medication use for major depression
  • participation in yoga classes within the past year
  • current or >1 year prior experience with mind/body therapies
  • currently participating in regular exercise classes
  • currently enrolled in quit smoking program
  • currently using quit smoking medications

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02055326


Locations
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United States, Rhode Island
The Miriam Hospital
Providence, Rhode Island, United States, 02906
Sponsors and Collaborators
The Miriam Hospital
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)

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Responsible Party: The Miriam Hospital
ClinicalTrials.gov Identifier: NCT02055326    
Other Study ID Numbers: AT003669-02S1
First Posted: February 5, 2014    Key Record Dates
Last Update Posted: February 5, 2014
Last Verified: January 2014
Keywords provided by The Miriam Hospital:
Smoking
yoga
men
intervention