Yoga for Men Attempting Smoking Cessation

Smoking Cessation Clinical Trial

Official title:

Complementary Treatments for Smoking Cessation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02055326
• Other study ID #: AT003669-02S1
• Status: Completed
• Phase: N/A
• First received: February 3, 2014
• Last updated: February 4, 2014
• Start date: September 2009
• Est. completion date: July 2011

Study information

• Verified date: January 2014
• Source: The Miriam Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: July 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• Cognitive Behavioral Therapy for Smoking Cessation
one hour weekly for 8 weeks. Cognitive behavioral therapy for smoking cessation
• Yoga
One hour, twice weekly for 8 weeks of vinyasa yoga
• Health & Wellness
Lectures, handouts and printed materials on general health and wellness topics including healthy eating, cancer prevention and cardiovascular disease prevention.

Locations

Country	Name	City	State
United States	The Miriam Hospital	Providence	Rhode Island

Sponsors (3)

Lead Sponsor	Collaborator
The Miriam Hospital	National Center for Complementary and Integrative Health (NCCIH), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking abstinence	7-day point prevalence abstinence was measured at 8 weeks, 3 and 6 months follow up	7 days	No