Acute Effects of Exercise in Smokers With Schizophrenia

NCT ID: NCT01635075

Last Updated: 2015-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2015-01-31

Brief Summary

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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

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Conditions

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Tobacco Dependence Cigarette Craving Smoking Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Exercise

1-mile treadmill walk

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

1-mile treadmill walk

Passive

20 min inactivity

Group Type PLACEBO_COMPARATOR

passive control

Intervention Type BEHAVIORAL

20 min inactivity

Interventions

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Exercise

1-mile treadmill walk

Intervention Type BEHAVIORAL

passive control

20 min inactivity

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brown University

OTHER

Sponsor Role lead

Responsible Party

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Jennifer Tidey

Associate Professor (Research)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jennifer Tidey, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Brown University

Locations

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Brown University

Providence, Rhode Island, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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1R21DA031283

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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