SchizophreniaPhase 1NCT00500695
Enhancing Motivation To Quit Smoking In Smokers With Serious Mental Illness
A Phase 1 study testing Motivational Interviewing and Psychoeducation in people with Schizophrenia and Schizoaffective Disorder, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
This project will assess the utility of a brief motivational intervention to engage smokers with schizophrenia in treatment for tobacco dependence treatment. It is hypothesized that a brief motivational intervention will be more effective in engaging smokers with schizophrenia to tobacco dependence treatment than an… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Motivational Interviewing and Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to Oct 2013
- Phase
- Phase 1
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current smokers must be over the age of 18,
- Must have a diagnosis of schizophrenia or schizoaffective disorder
- Must smoke at least 10 cigarettes per day
- Must be capable of giving informed consent as measured by Folstein Mini Mental Status Exam of at least 22
Who cannot join
- •Those unable to give informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
UMDNJ- Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
About this study
This project will assess the utility of a brief motivational intervention to engage smokers with schizophrenia in treatment for tobacco dependence treatment. It is hypothesized that a brief motivational intervention will be more effective in engaging smokers with schizophrenia to tobacco dependence treatment than an educational intervention. The educational intervention will increase the likelihood to reducing cigarette intake and/or attending tobacco dependence treatment by teaching subjects about the negative effects of smoking and the success of tobacco dependence treatment. The motivational intervention will increase the likelihood to reducing cigarette intake and/or attending tobacco dependence treatment by increasing subjects' motivation to change by presenting objective and personalized information regarding their smoking behaviors in a non-judgmental and supportive manner.
Read the detailed description
See Brief Summary above.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Motivational Interviewing, Psychoeducation
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational InterviewingBehavioural
Motivational Interviewing
PsychoeducationBehavioural
Psychoeducation
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interviewing | Experimental | Motivational Interviewing Receives: Behavioral: Motivational Interviewing |
| Psychoeducation | Active comparator | Psychoeducation Receives: Behavioral: Psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attendance at first smoking cessation session
Measured: one month
Secondary outcomes (1)
Cigarettes per day
Measured: 1-Month Follow Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2007 (estimated)
- Study startMay 2006
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Marc L. Steinberg, Ph.D., Rutgers, The State University of New Jersey
- Investigators
- Marc L. Steinberg, PH.D., Principal investigator, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00500695
- Sponsor's protocol ID
- 220045018
- Other IDs
- K23DA018203
- Status last verified
- Jul 2017
- First submitted
- 12 Jul 2007
- Last updated
- 18 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Motivation To Quit Smoking In Smokers With Serious Mental Illness
- ClinicalTrials.gov ID
- NCT00500695
- Acronym / sponsor ID
- 220045018
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- May 2006
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 13 Jul 2007 (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 will assess the utility of a brief motivational intervention to engage smokers with schizophrenia in treatment for tobacco dependence treatment. It is hypothesized that a brief motivational intervention will be more effective in engaging smokers with schizophrenia to tobacco dependence treatment than an educational intervention. The educational intervention will increase the likelihood to reducing cigarette intake and/or attending tobacco dependence treatment by teaching subjects about the negative effects of smoking and the success of tobacco dependence treatment. The motivational intervention will increase the likelihood to reducing cigarette intake and/or attending tobacco dependence treatment by increasing subjects' motivation to change by presenting objective and personalized information regarding their smoking behaviors in a non-judgmental and supportive manner.
Detailed description
See Brief Summary above.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing | Experimental | Behavioral: Motivational InterviewingMotivational Interviewing |
| Psychoeducation | Active comparator | Behavioral: PsychoeducationPsychoeducation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Current smokers must be over the age of 18,
- Must have a diagnosis of schizophrenia or schizoaffective disorder
- Must smoke at least 10 cigarettes per day
- Must be capable of giving informed consent as measured by Folstein Mini Mental Status Exam of at least 22
Key exclusion criteria (1 listed)
- •Those unable to give informed consent.
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 |
|---|---|---|
| Motivational InterviewingMotivational Interviewing | Behavioural | Motivational Interviewing |
| PsychoeducationPsychoeducation | Behavioural | Psychoeducation |
Primary outcome
Attendance at first smoking cessation session
Time frame: one month
1 secondary outcome
Cigarettes per day
Time frame: 1-Month Follow Up
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 18 Jul 2017.
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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.
Marc L. Steinberg, PH.D. principal investigator
Rutgers, The State University of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Motivational Interviewing and Psychoeducation in people with Schizophrenia and Schizoaffective Disorder, run by Rutgers, The State University of New Jersey 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 1 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 18 Jul 2017. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Attendance at first smoking cessation session (time frame: one month). 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 18 Jul 2017.