Acute Effects of Exercise in Smokers With Schizophrenia

Phase 2

Completed

• Conditions: Tobacco Dependence; Smoking Behavior; Cigarette Craving
• Interventions: Behavioral: Exercise; Behavioral: passive control

• Registration Number: NCT01635075
• Lead Sponsor: Brown University

Brief Summary

People with schizophrenia have two- to three-times the mortality risk of the general population. This is primarily due to their unusually high rates of cigarette smoking, as well as other cardiovascular risk factors such as physical inactivity, obesity, high blood cholesterol and diabetes. Effective smoking treatments are needed to reduce morbidity and mortality in this population. Over a dozen experimental studies indicate that walking and other forms of exercise acutely reduce cigarette craving, nicotine withdrawal symptoms and smoking behavior in non-psychiatric smokers. However, the effects of acute exercise on smoking measures have not been studied in smokers with schizophrenia. This study will use a within-subjects, repeated-measures design, in which participants will undergo 4 laboratory sessions (order counterbalanced across participants): (1) smoking cues followed by exercise, (2) smoking cues followed by passive activity, (3) neutral cues followed by exercise, (4) neutral cues followed by passive activity. Outcome measures include cigarette craving, nicotine withdrawal symptoms, mood and smoking behavior. If the results of this study indicate that walking acutely reduces craving and smoking in smokers with schizophrenia, the next step in this research would be to test the effectiveness of a smoking cessation intervention that incorporates exercise bouts as a behavioral strategy for improving smoking cessation rates in this population.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-19
• Study First Submitted QC: 2012-07-03
• Study First Posted: 2012-07-06
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-25
• Last Update Posted: 2015-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• diagnosis of schizophrenia
• smoke at least 20 cigarettes per day
• less than 60 min moderate-intensity exercise per week

Exclusion Criteria

• medication changes in past 4 weeks
• unable to give informed consent to participate
• alcohol/drug screen
• pregnant or nursing
• receiving or seeking immediate smoking treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Exercise	Exercise	1-mile treadmill walk
Passive	passive control	20 min inactivity

Primary Outcome Measures

Name	Time	Method
Cigarette craving	within 10 minutes before and after exercise (or control activity)	Questionnaire on Smoking Urges - Brief form

Secondary Outcome Measures

Name	Time	Method
Mood	within 10 minutes before and after exercise (or control activity)	Positive and Negative Affect Scales, which are brief questionnaire measures of positive and negative mood.
Smoking habit withdrawal	within 10 minutes before and after exercise (or control activity)	Questionnaire measures of withdrawal from sensorimotor aspects of smoking
Smoking choice	initiated 10 minutes after exercise (or control activity)	2-hr laboratory smoking choice assessment in which participants make a series of choices between smoking versus receiving a small amount of cash.

Trial Locations

Locations (1)

Brown University; 🇺🇸 Providence, Rhode Island, United States