Acute Effects of Exercise in Smokers With Schizophrenia

NCT01635075 | Completed Phase 2

• 1 other identifier: 1R21DA031283
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Dependence; Cigarette Craving; Smoking Behavior

Keywords

psychiatric; comorbidity; craving; tobacco

Outcome Measures

Primary Outcomes (1)

• Cigarette craving

  Questionnaire on Smoking Urges - Brief form

  within 10 minutes before and after exercise (or control activity)

Secondary Outcomes (3)

• Mood

  within 10 minutes before and after exercise (or control activity)

• Smoking habit withdrawal

  within 10 minutes before and after exercise (or control activity)

• Smoking choice

  initiated 10 minutes after exercise (or control activity)

Study Arms (2)

Exercise

EXPERIMENTAL

1-mile treadmill walk

Behavioral: Exercise

Passive

PLACEBO COMPARATOR

20 min inactivity

Behavioral: passive control

Interventions

Exercise BEHAVIORAL

1-mile treadmill walk

Exercise

passive control BEHAVIORAL

20 min inactivity

Passive

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brown University: lead

Study Sites (1)

Brown University

Providence, Rhode Island, 02912, United States

Location

Related Links

• Research site

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking

Interventions

Exercise

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jennifer Tidey, Ph.D.

  Brown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor (Research)

Study Record Dates

• First Submitted: June 19, 2012
• First Posted: July 6, 2012
• Study Start: June 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: September 28, 2015

Record last verified: 2015-09

Locations

US (1)