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Completed

NCT Number: NCT02055326

Yoga for Men Attempting Smoking Cessation

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.

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Key information

Conditions

Smoking Cessation Behavior Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocrine Gland Neoplasms Endocrine System Diseases Genetic Diseases, Inborn Health Behavior Multiple Endocrine Neoplasia Multiple Endocrine Neoplasia Type 1 Neoplasms Neoplasms by Site Neoplasms, Multiple Primary Neoplastic Syndromes, Hereditary Smoking

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

The Miriam Hospital

Providence, Rhode Island, 02906, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

cognitive behavioral therapy for smoking cessation

Behavioral

one hour weekly for 8 weeks. Cognitive behavioral therapy for smoking cessation

Yoga

Behavioral

One hour, twice weekly for 8 weeks of vinyasa yoga

Health & Wellness

Behavioral

Lectures, handouts and printed materials on general health and wellness topics including healthy eating, cancer prevention and cardiovascular disease prevention.

Primary outcomes

  1. Smoking abstinence

    Time frame: 7 days

    7-day point prevalence abstinence was measured at 8 weeks, 3 and 6 months follow up

Sponsors and collaborators

Lead sponsor

The Miriam Hospital

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)
  • National Institutes of Health (NIH)

Registry information

Official study title

Complementary Treatments for Smoking Cessation

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Feb 5, 2014
Registry last updated
Feb 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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