Overview

This trial is active, not recruiting.

Conditions yoga, waitlist
Treatment yoga
Sponsor University of Texas at Austin
Start date July 2014
End date July 2017
Trial size 50 participants
Trial identifier NCT02181179, 2014040107

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose basic science
Arm
(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.
yoga Hatha yoga
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.
(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.

Primary Outcomes

Measure
Measurement of Objective Stress through Hormonal Biomarkers (Hair & Salivary Cortisol)
time frame: Collected at pre-and-post intervention (Baseline and Quit day, Week 9)
Minnesota Nicotine Withdrawal Scale-Revised
time frame: post-yoga Week 9 on Quit day and week 10 follow-up

Secondary Outcomes

Measure
Self reported anxiety sensitivity - Anxiety Sensitivity Scale (ASI).
time frame: Weekly from pre-to-post intervention (screen, Baseline, weeks 1-10)
carbon monoxide (CO)
time frame: Screen, week 0 (baseline), week 9 Quit day, & week 10 follow up
Smoking point-prevalence - timeline follow back calendar
time frame: Weeks Screen, 0 (baseline), 1-8 (intervention), 9-10 (quit period)
Five Facet Mindfulness Questionnaire (FFMQ).
time frame: Weekly from baseline to post-yoga (week 9)
Barratt Impulsiveness Scale (BIS) of Trait Impulsivity
time frame: Eligibility Screen
Balloon Analogue Risk Task (BART).
time frame: Pre-to-post (at eligibility screen & week 9 visit).
Computerized Delay Discounting Task (DDT).
time frame: Pre-to-post (eligibility screen & week 9 visit)
Distress Tolerance Scale (DTS).
time frame: Weekly; Baseline (week 0) through week 10 follow up
Mood and Anxiety Symptom Questionnaire (MASQ).
time frame: Quit day week 9
Fagerstrom Test of Nicotine Dependence (FTND).
time frame: Week 0, 6, 9
Beck Depression Inventory (BDI).
time frame: Eligibility screen, weeks 0, 6, 9

Eligibility Criteria

Female participants from 18 years up to 65 years old.

Inclusion Criteria: - 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 Exclusion Criteria: - 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

Additional Information

Official title Examining Yoga's Effects on Aspects Related to Stress and Smoking Behavior
Principal investigator Johnna Medina, M.A.
Description As the leading cause of preventable death in the US and a major cause for chronic disease/mortality worldwide, smoking represents a major public health issue in need of effective interventions to reduce its burden. The development of such strategies is best directed by basic research on the biobehavioral processes underlying smoking maintenance and relapse. A major predictor of cessation failure is nicotine withdrawal, especially among individuals low in distress tolerance (DT). Reducing nicotine withdrawal-related distress and relapse in low DT smokers may require the regulation of certain hormones involved in the hypothalamic pituitary axis (HPA-axis) (i.e., the human stress response). Regular practice of yoga, a mindfulness-based form of physical activity, emerges as a promising strategy for regulating the HPA-axis, decreasing withdrawal symptoms, and increasing DT, thus promoting smoking cessation success. We will randomly assign 50 smokers (≥10 cigarettes daily) low in DT to either an 8-week yoga intervention [YOGA] or a waitlist control [WL] prior to undergoing a self-guided quit attempt. We hypothesize participants assigned to the yoga condition (relative to waitlist) will differ on various outcomes assessed throughout the intervention (e.g., quit status, negative affective states, stress, hormonal changes, withdrawal) and, quit day, and throughout the 2-week quit follow-up period. More specifically, we hypothesize that certain typical maladaptive, during-withdrawal changes may be attenuated through YOGA. We also hope to obtain initial effect sizes of the advantage of yoga compared to waitlist for point-prevalent abstinence at two weeks following an unaided quit attempt.
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by University of Texas at Austin.