Clinical trial NCT01417975: Effect of an Acute Bout of Exercise on Smoking Satisfaction
Official title: Does an Acute Bout of Exercise Affect Smoking Satisfaction?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: exercise
smoking satisfaction
topography
cravings
Lead sponsor: University of Western Ontario, Canada
Sponsor class: OTHER
First posted: 2011-08-16
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Female and male smokers will complete questionnaires and smoking behavior will be examined. After abstaining from smoking for approximately 18 hours, they will be randomized to a moderate intensity exercise groups or passive sitting group. Smoking satisfaction and smoking behavior will be assessed following treatment.

The hypotheses detailed below are specific to the randomization of participants into the following 2 groups:

1. Moderate exercise (Experimental condition; MEG)
2. Passive sitting (Attention control condition; PSG)

Hypothesis 1: A bout of moderate intensity exercise will be associated with decreased smoking satisfaction after a temporary period of abstinence compared to a control condition.

Hypothesis 2: Smoking topographic measures will mediate the relationship between a bout of moderate intensity exercise and smoking satisfaction.

Detailed description: Lung cancer is the leading cause of cancer death in Canadians (Canadian Cancer Society (CCS), 2010). Cigarette smoking is responsible for 85% of these cases (CCS, 2007). Exercise has been shown to be an effective adjunct to pharmacological cessation strategies (Ussher, Taylor, \& Faulkner, 2008). A recent systematic review concluded that a single bout of low to moderate intensity exercise can help regulate cravings, withdrawal symptoms and negative affect associated with quitting (Taylor, Ussher, \& Faulkner, 2007).

Smoking satisfaction is an immediately reinforcing effect of nicotine. Smoking satisfaction may outweigh the temporally distant adverse health risks of smoking (Cappelleri, Bushmakin, Baker, Merikle, Olufade, \& Gilbert, 2007). Varenicline, an alpha 4-beta-2 nAChR partial agonist, mimics the effect of nicotine by reducing cravings and withdrawal symptoms (Coe et al., 2005). A 12-week treatment period of varenicline has been shown to reduce smoking satisfaction (Jorenby et al., 2006). However, the effect of acute exercise on smoking satisfaction is not yet known.

Smoking topography is a key facet of smoking behaviour. Smoking behaviour can be subjectively or objectively measured by quantifying puff volume, maximum puff velocity, inter-puff interval, puff duration, number of puffs per cigarette and time to smoke a single cigarette. Smoking topography can estimate exposure to carcinogenic toxins present in cigarette smoking (Djordjevic, Hoffman, \& Hoffman, 1997). Evidence exists to support that exercise modifies smoking topography (Katomeri \& Taylor 2006; Mikhail, 1983; Reeser, 1983; Zacny \& Stitzer, 1985).

Eligibility criteria: Inclusion Criteria:

* 18 to 64 years of age
* Smoke 10 or more cigarettes per day
* Not have any medical condition that is contraindicative for exercise
* Not be pregnant or intending on becoming pregnant over the course of the study
* Be able to read and write in English
* Have a telephone or e-mail account so they can be contacted
* Successful completion of the Physical Activity Readiness Questionnaire (PAR-Q)
* Have a Medical Doctor's clearance if they answer "YES" to one or more questions on the Physical Activity Readiness Questionnaire (PAR-Q)
* Have not been engaged in a serious quit attempt in the last six months
* Have been smoking for more than 2 years
* Must not be suffering from an illness (e.g. cold) that would affect their typical smoking behaviour

Exclusion Criteria:

* Contraindication to exercise (e.g. disability, unstable angina)
* On medication for physical and/or mental health reasons that would make compliance with the study protocol difficult or dangerous
* Have substance dependency problems (e.g. alcohol)
* Are pregnant
* Be younger than 18 years of age
* Be 64 years or older prior to completion of the study
* Have been engaged in a serious quite attempt in the last six months
* Have been smoking for less than 2 years
* Suffering from an illness (e.g. cold) that would affect their typical smoking behaviour

Primary outcomes:
measure: Smoking satisfaction
timeFrame: One week
Secondary outcomes:
measure: Smoking topography
timeFrame: One week
Other outcomes:
Locations:
city: London
country: Canada
facility: The Exercise and Health Psychology Laboratory - The University of Western Ontario
state: Ontario
Study officials:
affiliation: The University of Western Ontario
name: Harry Prapavessis, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ussher MH, Taylor A, Faulkner G. Exercise interventions for smoking cessation. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD002295. doi: 10.1002/14651858.CD002295.pub3.
citation: Taylor AH, Ussher MH, Faulkner G. The acute effects of exercise on cigarette cravings, withdrawal symptoms, affect and smoking behaviour: a systematic review. Addiction. 2007 Apr;102(4):534-43. doi: 10.1111/j.1360-0443.2006.01739.x.
citation: Taylor A, Katomeri M. Walking reduces cue-elicited cigarette cravings and withdrawal symptoms, and delays ad libitum smoking. Nicotine Tob Res. 2007 Nov;9(11):1183-90. doi: 10.1080/14622200701648896.
citation: West R, Baker CL, Cappelleri JC, Bushmakin AG. Effect of varenicline and bupropion SR on craving, nicotine withdrawal symptoms, and rewarding effects of smoking during a quit attempt. Psychopharmacology (Berl). 2008 Apr;197(3):371-7. doi: 10.1007/s00213-007-1041-3. Epub 2007 Dec 15.