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Acute Effects of Exercise in Smokers With Schizophrenia

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Brown University

Status and phase

Completed
Phase 2

Conditions

Tobacco Dependence
Smoking Behavior
Cigarette Craving

Treatments

Behavioral: Exercise
Behavioral: passive control

Study type

Interventional

Funder types

Other

Identifiers

NCT01635075
1R21DA031283

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

30 participants in 2 patient groups, including a placebo group

Exercise
Experimental group
Description:
1-mile treadmill walk
Treatment:
Behavioral: Exercise
Passive
Placebo Comparator group
Description:
20 min inactivity
Treatment:
Behavioral: passive control

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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