Tobacco DependencePhase 2NCT01635075
Acute Effects of Exercise in Smokers With Schizophrenia
A Phase 2 study testing Exercise in people with Tobacco Dependence and Cigarette Craving, run by Brown University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Tobacco Dependence, Cigarette Craving, Smoking Behavior
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Jan 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- diagnosis of schizophrenia
- smoke at least 20 cigarettes per day
- less than 60 min moderate-intensity exercise per week
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Exercise, passive control
- Keywords
- psychiatric, comorbidity, craving, tobacco
- Medical subject headings
- Tobacco Use Disorder, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
1-mile treadmill walk
passive controlBehavioural
20 min inactivity
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | 1-mile treadmill walk Receives: Behavioral: Exercise |
| Passive | Placebo comparator | 20 min inactivity Receives: Behavioral: passive control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cigarette craving
Questionnaire on Smoking Urges - Brief form
Measured: within 10 minutes before and after exercise (or control activity)
Secondary outcomes (3)
Mood
Positive and Negative Affect Scales, which are brief questionnaire measures of positive and negative mood.
Measured: within 10 minutes before and after exercise (or control activity)
Smoking habit withdrawal
Questionnaire measures of withdrawal from sensorimotor aspects of smoking
Measured: within 10 minutes before and after exercise (or control activity)
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.
Measured: initiated 10 minutes after exercise (or control activity)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco DependenceStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Tidey, Brown University
- Investigators
- Jennifer Tidey, Ph.D., Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01635075
- Sponsor's protocol ID
- 1R21DA031283
- Status last verified
- Sep 2015
- First submitted
- 19 Jun 2012
- Last updated
- 28 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Exercise in Smokers With Schizophrenia
- ClinicalTrials.gov ID
- NCT01635075
- Acronym / sponsor ID
- 1R21DA031283
- Conditions
- Tobacco Dependence, Cigarette Craving, Smoking Behavior
- Keywords
- psychiatric, comorbidity, craving, tobacco
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 6 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: Exercise1-mile treadmill walk |
| Passive | Placebo comparator | Behavioral: passive control20 min inactivity |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- diagnosis of schizophrenia
- smoke at least 20 cigarettes per day
- less than 60 min moderate-intensity exercise per week
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise1-mile treadmill walk | Behavioural | Exercise |
| passive control20 min inactivity | Behavioural | Passive |
Primary outcome
Cigarette craving
Time frame: within 10 minutes before and after exercise (or control activity)
Questionnaire on Smoking Urges - Brief form
3 secondary outcomes
Mood
Time frame: within 10 minutes before and after exercise (or control activity)
Smoking habit withdrawal
Time frame: within 10 minutes before and after exercise (or control activity)
Smoking choice
Time frame: initiated 10 minutes after exercise (or control activity)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2015.
- Research siteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Tidey, Ph.D. principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Exercise in people with Tobacco Dependence and Cigarette Craving, run by Brown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cigarette craving (time frame: within 10 minutes before and after exercise (or control activity)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2015.