Tobacco Use DisorderPhase 2WRENNCT01214005
Smoking Abstinence and Lapse Effects in Smokers With Schizophrenia and Controls
A Phase 2 study testing smoking abstinence in people with Tobacco Use Disorder and Schizophrenia, run by Brown University at 1 site in United States.
Trial summary
This project tests two hypotheses concerning the low smoking cessation rates in smokers with schizophrenia. The first hypothesis is that smokers with schizophrenia experience stronger and more sustained effects of smoking abstinence on negative mood and smoking urge than control smokers without psychiatric illness. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Disorder, Schizophrenia
- What is being tested?
- smoking abstinence
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Feb 2012
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- cigarette smokers, 20-50 cigarettes per day
- schizophrenia or no psychiatric illness
- age 18 or older
- male or female
Who cannot join
- unstable symptoms or medication
- not interested in quitting smoking within 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Brown University, 121 South Main Street
Providence, Rhode Island, 02912
About this study
This project tests two hypotheses concerning the low smoking cessation rates in smokers with schizophrenia. The first hypothesis is that smokers with schizophrenia experience stronger and more sustained effects of smoking abstinence on negative mood and smoking urge than control smokers without psychiatric illness. The second hypothesis is that smokers with schizophrenia experience stronger reinforcing effects of a smoking lapse (i.e., more rewarding effects of smoking after a period of abstinence) than control smokers without psychiatric illness.
Read the detailed description
In this study, smokers with schizophrenia and smokers without psychiatric illness participate in a nicotine preference task before and after a 3-day period of continuous smoking abstinence. The investigators will experimentally control abstinence by providing participants with high-value cash incentives contingent upon smoking abstinence verified with breath carbon monoxide levels. The investigators will measure nicotine withdrawal and smoking urge during the abstinence period. In the nicotine preference task, participants will make choices between nicotine-containing and denicotinized cigarette puffs to provide a measure of nicotine reinforcement, and the investigators will also measure the effects of smoking on mood. After the second nicotine preference task, participants will receive a small-value reinforcer if they continue to abstain for another day, and the investigators will measure time to the second lapse.
- Conditions
- Tobacco Use Disorder, Schizophrenia
- Being tested
- smoking abstinence
- Keywords
- nicotine, reinforcement, craving, relapse
- Medical subject headings
- Tobacco Use Disorder, Schizophrenia, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smoking abstinenceBehavioural
3 days of biologically-confirmed smoking abstinence
| Study group | Role | What they receive |
|---|---|---|
| schizophrenia | Experimental | Smokers with schizophrenia or schizoaffective disorder Receives: Behavioral: smoking abstinence |
| non-psychiatric | Other | smokers without psychiatric illness Receives: Behavioral: smoking abstinence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Withdrawal symptoms
negative mood related to nicotine withdrawal
Measured: 3 days
urge to smoke
craving for smoking
Measured: 3 days
nicotine preference
choice for nicotine puffs versus denicotinized cigarette puffs
Measured: before and after 3 days of abstinence
positive and negative mood
positive and negative mood scale
Measured: before and after 3 days of abstinence
Secondary outcomes (1)
time to lapse
time between smoking behavior in the laboratory and first cigarette outside of the laboratory
Measured: 192 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2010 (estimated)
- Study startJun 2009
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use DisorderStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 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
- NCT01214005
- Sponsor's protocol ID
- R21DA026829
- Acronym
- WREN
- Status last verified
- Apr 2012
- First submitted
- 1 Oct 2010
- Last updated
- 27 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking Abstinence and Lapse Effects in Smokers With Schizophrenia and Controls
- ClinicalTrials.gov ID
- NCT01214005
- Acronym / sponsor ID
- WREN / R21DA026829
- Conditions
- Tobacco Use Disorder, Schizophrenia
- Keywords
- nicotine, reinforcement, craving, relapse
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 4 Oct 2010 (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.
This project tests two hypotheses concerning the low smoking cessation rates in smokers with schizophrenia. The first hypothesis is that smokers with schizophrenia experience stronger and more sustained effects of smoking abstinence on negative mood and smoking urge than control smokers without psychiatric illness. The second hypothesis is that smokers with schizophrenia experience stronger reinforcing effects of a smoking lapse (i.e., more rewarding effects of smoking after a period of abstinence) than control smokers without psychiatric illness.
Detailed description
In this study, smokers with schizophrenia and smokers without psychiatric illness participate in a nicotine preference task before and after a 3-day period of continuous smoking abstinence. The investigators will experimentally control abstinence by providing participants with high-value cash incentives contingent upon smoking abstinence verified with breath carbon monoxide levels. The investigators will measure nicotine withdrawal and smoking urge during the abstinence period. In the nicotine preference task, participants will make choices between nicotine-containing and denicotinized cigarette puffs to provide a measure of nicotine reinforcement, and the investigators will also measure the effects of smoking on mood. After the second nicotine preference task, participants will receive a small-value reinforcer if they continue to abstain for another day, and the investigators will measure time to the second lapse.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| schizophrenia | Experimental | Behavioral: smoking abstinenceSmokers with schizophrenia or schizoaffective disorder |
| non-psychiatric | Other | Behavioral: smoking abstinencesmokers without psychiatric illness |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- cigarette smokers, 20-50 cigarettes per day
- schizophrenia or no psychiatric illness
- age 18 or older
- male or female
Key exclusion criteria (2 listed)
- unstable symptoms or medication
- not interested in quitting smoking within 6 months
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 |
|---|---|---|
| smoking abstinence3 days of biologically-confirmed smoking abstinence | Behavioural | non-psychiatric, schizophrenia |
Primary outcome
Withdrawal symptoms
Time frame: 3 days
negative mood related to nicotine withdrawal
urge to smoke
Time frame: 3 days
craving for smoking
nicotine preference
Time frame: before and after 3 days of abstinence
choice for nicotine puffs versus denicotinized cigarette puffs
positive and negative mood
Time frame: before and after 3 days of abstinence
positive and negative mood scale
1 secondary outcome
time to lapse
Time frame: 192 hours
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 27 Apr 2012.
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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 smoking abstinence in people with Tobacco Use Disorder and Schizophrenia, 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 4 inclusion and 2 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 27 Apr 2012. 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. 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?
Withdrawal symptoms (time frame: 3 days). The study lists 4 primary outcomes in all. 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 27 Apr 2012.