Examining Yoga's Effects on Smoking

NCT02181179 | Completed DMC

• 1 other identifier: 2014040107
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this research study is to examine the effects of an 8-week yoga program on aspects related to nicotine dependence, stress, and coping during a smoking quit attempt. Guided by initial studies reporting on the effects of yoga on putative mediators of smoking relapse (i.e., cortisol, distress intolerance, withdrawal symptoms), the proposed experiment examines the effects of an 8-week yoga practice on nicotine withdrawal intensity by way of aiding withdrawal characteristics predictive of smoking relapse. The long-term objectives of the proposed line of research are to: (1) inform theoretical models of nicotine withdrawal, (2) guide the development of effective alternative interventions for smokers susceptible to relapse during the critical withdrawal period (i.e., smokers low in distress tolerance), and (3) to help guide behavioral strategies for treating substance addictions broadly.

Conditions

Yoga; Waitlist

Keywords

yoga; exercise intervention; smoking; stress; mind-body; intervention

Outcome Measures

Primary Outcomes (2)

• Measurement of Objective Stress through Hormonal Biomarkers (Hair & Salivary Cortisol)

  we will collect biological samples of hair and saliva to assess changes in biomarkers in response to yoga, and as a potential mechanism by which yoga may aid in smoking cessation. Saliva samples will be collected with Salivettes (Sarstedt, Rommelsdorf, Germany), plastic vials with cotton dental rolls inside. Participants will complete 2 Salivettes at each of three separate 12-hr collection periods. participants will provide two hair strand samples cut by trained personnel (Gerber et al., 2012; Suave et al., 2007; Meyer \& Novak, 2012). Hair strands are cut close to the scalp from the posterior vertex of the head using surgical scissors.

  Collected at pre-and-post intervention (Baseline and Quit day, Week 9)

• Minnesota Nicotine Withdrawal Scale-Revised

  MNWS-R (Hughes \& Hatsukami, 1986) is a validated 15-item self-report measure of withdrawal severity rated on a 5 point Likert scale (0 "none" to 4 "severe") that will establish level of nicotine withdrawal as a major outcome assessed between groups during quit period.

  post-yoga Week 9 on Quit day and week 10 follow-up

Secondary Outcomes (11)

• Self reported anxiety sensitivity - Anxiety Sensitivity Scale (ASI).

  Weekly from pre-to-post intervention (screen, Baseline, weeks 1-10)

• carbon monoxide (CO)

  Screen, week 0 (baseline), week 9 Quit day, & week 10 follow up

• Smoking point-prevalence - timeline follow back calendar

  Weeks Screen, 0 (baseline), 1-8 (intervention), 9-10 (quit period)

• Five Facet Mindfulness Questionnaire (FFMQ).

  Weekly from baseline to post-yoga (week 9)

• Barratt Impulsiveness Scale (BIS) of Trait Impulsivity

  Eligibility Screen

Study Arms (2)

Yoga

ACTIVE COMPARATOR

This will involve participating in at least two 60-minute Vinyasa yoga sessions each week for eight weeks (weeks 1-8). This will begin the week following a baseline laboratory appointment. These sessions will be conducted at a local Austin studio that has numerous locations in the area.

Behavioral: Yoga

Waitlist

NO INTERVENTION

If randomized to this group, participants will complete weekly assessments only and not yoga during their time in the study. Following full completion of the study (i.e., after week 10), participants will be compensated with a voucher for 2 free months of yoga.

Interventions

Yoga BEHAVIORAL

The yoga intervention will be an 8-week program involving two 60-minute sessions each week at a local studio with three locations in Austin. Participants will be instructed to take classes deemed within a moderate-to-vigorous intensity dose. Participants will also be encouraged both by the PI and yoga instructors to complete the entire 60 minutes of yoga, urged to do only what is comfortable and not push themselves beyond their physical limits.

Also known as: Hatha yoga, vinyasa yoga

Yoga

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female only patients ages 18-65 capable of providing informed consent
• Daily smoker for at least one year.
• Currently smoke an average of at least 10 cigarettes per day.
• Sedentary as defined by moderate-intensity exercise less than 2 days/wk for at least 30 minutes each
• Written physician approval/medical clearance to participate in an exercise/yoga protocol.
• Report motivation to quit smoking of at least 5 on a 10-point Likert-type scale - -Express interest in making a serious, unassisted quit attempt in the next month-
• Have not decreased number of cigarettes smoked in the past 6 months

You may not qualify if:

• Use of other tobacco products
• Severe obesity (BMI ≥ 40)
• Currently pregnant or plans to become pregnant
• Diagnosis of a schizophrenia or bipolar-spectrum disorder
• Currently suicidal or suicide high-risk or severe depression
• Use of corticosteroid medications
• Change in medication doses for past 6-months for psychotropic drugs
• Receiving concurrent psychotherapy

Sponsors & Collaborators

• University of Texas at Austin: lead

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78712, United States

Location

Related Links

• Anxiety and Health Behaviors Lab

MeSH Terms

Conditions

Smoking

Interventions

Yoga

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Johnna Medina, M.A.

  University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2014
• First Posted: July 3, 2014
• Study Start: July 1, 2014
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: October 26, 2017

Record last verified: 2017-10

Locations

US (1)