Acute Effects of Exercise in Smokers With Schizophrenia

Tobacco Dependence Clinical Trial

Official title:

Acute Effects of Exercise in Smokers With Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01635075
• Other study ID #: 1R21DA031283
• Status: Completed
• Phase: Phase 2
• First received: June 19, 2012
• Last updated: September 25, 2015
• Start date: June 2012
• Est. completion date: January 2015

Study information

• Verified date: September 2015
• Source: Brown University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Cigarette Craving
• Smoking Behavior
• Tobacco Dependence

Intervention

Behavioral:
• Exercise
1-mile treadmill walk
• passive control
20 min inactivity

Locations

Country	Name	City	State
United States	Brown University	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Brown University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cigarette craving	Questionnaire on Smoking Urges - Brief form	within 10 minutes before and after exercise (or control activity)	No
Secondary	Mood	Positive and Negative Affect Scales, which are brief questionnaire measures of positive and negative mood.	within 10 minutes before and after exercise (or control activity)	No
Secondary	Smoking habit withdrawal	Questionnaire measures of withdrawal from sensorimotor aspects of smoking	within 10 minutes before and after exercise (or control activity)	No
Secondary	Smoking choice	2-hr laboratory smoking choice assessment in which participants make a series of choices between smoking versus receiving a small amount of cash.	initiated 10 minutes after exercise (or control activity)	No

External Links

•   Research site