Overview

This trial is active, not recruiting.

Condition tobacco dependence
Treatments hatha yoga (hy), cardiovascular exercise (ce), smoking cessation counseling
Sponsor H. Lee Moffitt Cancer Center and Research Institute
Start date August 2007
End date March 2017
Trial size 79 participants
Trial identifier NCT01423578, MCC-15245

Summary

The overall purpose of this pilot study is to examine effects of Hatha yoga and cardiovascular exercise on craving, mood, cue reactivity, and smoking behavior. Our preliminary study indicated that a single session of either form of activity intervention improved mood, and the yoga intervention appeared to decrease cravings to smoke. The proposed study will extend this preliminary research in several ways.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Active Comparator)
Exercise and Smoking Cessation Counseling
hatha yoga (hy) yoga
3 Sessions of yoga instruction
smoking cessation counseling control group
4 smoking cessation counseling visits.
(Experimental)
Exercise and Smoking Cessation Counseling
cardiovascular exercise (ce) exercise
3 sessions of cardiovascular exercise
smoking cessation counseling control group
4 smoking cessation counseling visits.
(Other)
Control Group - Smoking Cessation Counseling
smoking cessation counseling control group
4 smoking cessation counseling visits.

Primary Outcomes

Measure
The Number of Participants Reporting Post Intervention Effects
time frame: Average of 6 Months

Secondary Outcomes

Measure
Number of Participants Reporting Behavior Changes Post Intervention
time frame: Average of 6 Months

Eligibility Criteria

Male or female participants from 18 years up to 55 years old.

Inclusion Criteria: - Smoke at least 10 cigarettes per day - Smoked regularly at least 2 years - Carbon monoxide reading at least 8 ppm - Interest in quitting smoking - Able to read and understand the consent form and questionnaires - Not currently practicing yoga Exclusion Criteria: - Current Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) (American Psychiatric Association, 1994) psychosis - Major depressive episode, manic episode, or panic disorder - Current DSM-IV psychoactive substance dependence or use - Current medication use that might affect physiological responses - Current use of bupropion, varenicline, or nicotine-containing products other than cigarettes - Significant health problems that might compromise physiological data collection or be contraindicated for moderate physical exercise or yoga - Significant hearing or visual impairment; pregnant as determined by urine human chorionic gonadotropin (hCG) test or nursing females - Body mass index (BMI) 35 or greater

Additional Information

Official title Effects of Yoga and Cardiovascular Exercise on Smoking Motivation
Principal investigator David J. Drobes, Ph.D.
Description First, the investigators will expand the exercise-based interventions from one to three sessions, which will more closely resemble how these interventions may be used in the context of smoking cessation. Second, the investigators will recruit smokers who are motivated to quit smoking, further increasing the clinical relevance of the research. Finally, the investigators will examine the effects of the interventions on actual smoking behavior within and outside of the laboratory setting. This may appropriately be considered a "proof of concept" study, as the investigators will not be powered to detect treatment outcome (smoking cessation) differences, nor are the interventions designed to maximize clinical smoking cessation outcomes. Participants will be randomized to receive 3-sessions of yoga instruction, 3-sessions of cardiovascular exercise, or to a no activity control group. Sessions will be scheduled to occur approximately 7 days apart, with a minimum of 4 between sessions. Mood and craving will be assessed before and after each session, and smoking behavior will be assessed following each session. Finally, a detailed cue reactivity assessment will be conducted prior to the first session and following the last session. Analyses will examine intervention effects on craving, mood, cue reactivity, and smoking behavior. In addition, the investigators will examine several potential mediators and moderators of intervention effects on smoking behavior. Finally, the investigators will continue to examine the feasibility and potential acceptability of each active intervention, to assist in developing future clinical applications of these techniques in the context of smoking cessation.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute.