Hatha Yoga for Smoking Cessation

Smoking Cessation Clinical Trial

Official title:

Hatha Yoga as an Adjunct to Cognitive Behavioral Therapy for Smoking Cessation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01633632
• Other study ID #: 12-16438/13-16721
• Status: Completed
• Phase: N/A
• First received: July 2, 2012
• Last updated: December 10, 2015
• Start date: August 2012
• Est. completion date: May 2015

Study information

• Verified date: December 2015
• Source: Creighton University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether Hatha Yoga can improve the chances of a successful smoking quit attempt.

Description:

While many smoking cessation interventions have been studied, even the most successful interventions result in less than 40% abstinence from smoking at 6 months. Most people attempt to quit multiple times before maintaining long-term abstinence from tobacco. Research into interventions to improve quit rates and decrease smoking prevalence is a high priority for multiple organizations. Yoga is an attractive non-pharmacological option because it can be used safely during pregnancy and lactation, can be combined with other pharmacologic and non-pharmacologic treatments, and can be continued well past the smoking cessation date to combat withdrawal symptoms and cravings. There is a critical need for innovative and effective methods for tobacco control that focus on both prevention and cessation.

This project will be broken into two stages. The first stage will aim to pilot test yoga techniques for feasibility and acceptability. Recruitment and retention strategies will be tested and participant satisfaction will be evaluated. Preliminary measures of smoking abstinence and withdrawal symptoms will be conducted.

The second stage of this study will be a randomized trial to compare smoking abstinence with cognitive behavioral therapy (CBT), CBT + yoga, or yoga alone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Age 19 years or older

• Smoker of 5 or more cigarettes per day

• Willing and physically able to participate in yoga

• Not currently practicing Hatha yoga.

Exclusion Criteria:

• Use of smokeless tobacco

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• Hatha yoga
30 minutes of instruction in Hatha yoga will be provided for 8 sessions.
• Cognitive behavioral therapy
8-sessions of cognitive behavioral therapy will be provided following a standardized curriculum.

Locations

Country	Name	City	State
United States	Creighton University	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Creighton University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Burns TL, Mayer AE, Washington-Krauth SM, Walters RW, Arouni AJ. Design and Feasibility of a Hatha Yoga Intervention for Smoking Cessation. Journal of Smoking Cessation 2014; doi:10.1017/jsc.2014.21.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Point prevalence abstinence from smoking	Abstinence from smoking as measured by expired carbon monoxide at the end of the 7-week intervention.	End of intervention (week 7)	No
Secondary	Abstinence from smoking	Prolonged abstinence defined as no smoking after the identified "quit date" and point prevalence abstinence (no smoking in the past 7 days) will be measured. Measured by self-report.	3 and 6 months	No
Secondary	Change in weight	Change in weight from baseline to week 7	End of intervention (week 7)	No
Secondary	Signs and symptoms of nicotine withdrawal	Survey will be administered weekly during class sessions	Weeks 1-7 during intervention period	No