Clinical trial NCT02181179: Examining Yoga's Effects on Smoking
Official title: Examining Yoga's Effects on Aspects Related to Stress and Smoking Behavior
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Yoga
Waitlist
Keywords: yoga
exercise intervention
smoking
stress
mind-body
intervention
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2014-07-03
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Measurement of Objective Stress through Hormonal Biomarkers (Hair & Salivary Cortisol)
timeFrame: Collected at pre-and-post intervention (Baseline and Quit day, Week 9)
measure: Minnesota Nicotine Withdrawal Scale-Revised
timeFrame: post-yoga Week 9 on Quit day and week 10 follow-up
Secondary outcomes:
measure: Self reported anxiety sensitivity - Anxiety Sensitivity Scale (ASI).
timeFrame: Weekly from pre-to-post intervention (screen, Baseline, weeks 1-10)
measure: carbon monoxide (CO)
timeFrame: Screen, week 0 (baseline), week 9 Quit day, & week 10 follow up
measure: Smoking point-prevalence - timeline follow back calendar
timeFrame: Weeks Screen, 0 (baseline), 1-8 (intervention), 9-10 (quit period)
measure: Five Facet Mindfulness Questionnaire (FFMQ).
timeFrame: Weekly from baseline to post-yoga (week 9)
measure: Barratt Impulsiveness Scale (BIS) of Trait Impulsivity
timeFrame: Eligibility Screen
measure: Balloon Analogue Risk Task (BART).
timeFrame: Pre-to-post (at eligibility screen & week 9 visit).
measure: Computerized Delay Discounting Task (DDT).
timeFrame: Pre-to-post (eligibility screen & week 9 visit)
measure: Distress Tolerance Scale (DTS).
timeFrame: Weekly; Baseline (week 0) through week 10 follow up
measure: Mood and Anxiety Symptom Questionnaire (MASQ).
timeFrame: Quit day week 9
measure: Fagerstrom Test of Nicotine Dependence (FTND).
timeFrame: Week 0, 6, 9
measure: Beck Depression Inventory (BDI).
timeFrame: Eligibility screen, weeks 0, 6, 9
Other outcomes:
Locations:
city: Austin
country: United States
facility: University of Texas at Austin
state: Texas
Study officials:
affiliation: University of Texas at Austin
name: Johnna Medina, M.A.
role: PRINCIPAL_INVESTIGATOR
References: