Schizoaffective DisorderPhase 2/3NCT00960375
Smoking Cessation for Veterans With Severe and Persistent Mental Illness
A Phase 2/3 study testing BTSCS and StSST in people with Schizoaffective Disorder and Schizophrenia, run by US Department of Veterans Affairs at 2 sites in United States.
Trial summary
The investigators have developed an intervention called Behavioral Treatment of Smoking Cessation in SPMI (BTSCS), an innovative intervention that supplements pharmacotherapy and education with contingency management and a multifaceted behavioral group treatment program that lasts for three months (24 group meetings). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Schizoaffective Disorder, Schizophrenia, Affective Psychosis, Bipolar
- What is being tested?
- BTSCS and StSST
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 179 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2010to Dec 2014
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DSM-IV diagnosis of severe and persistent mental illness (SPMI) including a diagnosis of a psychotic disorder in keeping with criteria established by the Serious Mental Illness Treatment Research and Evaluation Center (SMITREC) -Schizophrenic disorders, affective psychoses and other psychotic diagnoses. We also include individuals with a diagnosis of Major Depression with psychotic features and PTSD.
- Age 18-75
- Nicotine dependence as defined by a score of 5 or higher on the Fagerstrom Tolerance Scale OR Participants who currently smoke at least 10 cigarettes per day
- Participants will not meet criteria for current alcohol/substance dependence (other than nicotine)
- Willingness ability to provide consent to participate.
Who cannot join
- Documented history of severe neurological disorder or severe head trauma with loss of consciousness
- Severe or profound mental retardation by chart review.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201
Washington DC VA Medical Center, Washington, DC
Washington D.C., District of Columbia, 20422
About this study
Official title: Randomized Trial of a Smoking Cessation Program for Persons With SMI
The investigators have developed an intervention called Behavioral Treatment of Smoking Cessation in SPMI (BTSCS), an innovative intervention that supplements pharmacotherapy and education with contingency management and a multifaceted behavioral group treatment program that lasts for three months (24 group meetings). BTSCS is designed to address the cognitive, motivational, and social support problems characteristic of people with SPMI.
The investigators propose to conduct a randomized trial for persons with SPMI that compares (1) BTSCS: a 6-month manualized smoking cessation program adapted from an effective substance abuse treatment program for this population to (2) StSST: a standard manualized smoking cessation program which reflects current best practices.
Read the detailed description
Smoking is the leading cause of preventable death in the United States. Smoking contributes to increased rates of diseases such as lung cancer and heart disease, and adds dangerous complications to health problems such as diabetes and obesity. Despite widespread recognition of the devastating health effects of smoking, over 70% of people with schizophrenia and other serious and persistent mental illnesses (SPMI) smoke cigarettes, a rate that is at least double that of the general population and remains high despite decreases in rates of smoking in the general population. These extraordinary smoking rates contribute to elevated morbidity and mortality, have other life-threatening health-related consequences, and increase health care costs for treating smoking related illnesses in this population. Treating smoking is critical in improving the health of people with SPMI.
The newly revised VA/Department of Defense Clinical Practice Guideline for the Management of Tobacco Use outlines the VHA's comprehensive program for smoking cessation. Beginning in 1997, the VA central office directed that the Agency for Health Care Policy and Research (AHCPR) smoking cessation guideline (the 5 A's - Ask, Advise, Assess, Assist, Arrange) be implemented in all its health care facilities. Reinforcing their commitment to increasing veterans' access to evidence-based smoking cessation interventions, the VHA recently released a new policy mandating that smoking cessation treatment be made available without restriction at all VA sites. Our previous study implementing the 5A's in community mental health clinics has found reduced smoking and increased use of smoking cessation aids such as nicotine replacement therapy (NRT), but no only modest increases in abstinence. Implementation of the 5 A's was limited by inability to adequately assist patients to stop smoking. Consideration of how best to supplement the "Assist" and "Arrange" phases reveals the troubling observation that existing "best practice" treatments for smoking cessation have limited effectiveness for persons with SPMI. The most widely tested treatments consist generally of adaptations of American Lung Association (ALA) or comparable 10-14 session weekly groups supplemented by either nicotine replacement therapy (NRT) or Bupropion. Such programs produce low abstinence rates (0-25%) at end of intervention. Sustained abstinence is virtually non-existent. Abstinence at 6-month or 1-year follow-up points ranges from 0-10%.
We have developed an intervention the treatment of cocaine and heroin use disorders among persons with SPMI, called Behavioral Treatment for Substance Abuse in Serious and Persistent Mental Illness (BTSAS). BTSAS was developed with a series of National Institute on Drug Abuse (NIDA-funded treatment development grants as a treatment program for substance abuse that accommodated the cognitive and motivational impairments that characterize SPMI. The goal was to incorporate strategies that have been found to be effective in reducing drug use more generally, but to tailor them to meet the needs of people with SPMI. BTSAS provides a model for this application's test of an innovative smoking cessation treatment. Our basic premise is that we must first acknowledge nicotine dependence as an addiction with characteristics common to other substance addictions, and then specify the additional biological, social, cognitive, psychological and environmental barriers to quitting smoking for people with SPMI. We must then fully optimize available technologies for addiction in general and smoking cessation in particular to address these deficits. Existing approaches to smoking cessation for persons with SPMI do not use the full range of biological, contingency management, social modeling and behavioral tools that have been shown to work in treating other addictions in this population. Further, research on treatment of substance use disorders in persons with SPMI has suggested that, for best outcomes, interventions may need to be more intensive that what is provided for other groups of substance abusers. Applied to smoking, this suggests that for people with SPMI, smoking cessation may need to be more intensive than the 9 weekly sessions typical of conventional smoking cessation programs.
Based on our work developing BTSAS, and the above features of smoking in SPMI, we have developed an intervention called Behavioral Treatment of Smoking Cessation in SPMI (BTSCS), an innovative intervention that supplements pharmacotherapy and education with breath carbon monoxide monitoring and a multifaceted behavioral group treatment program that lasts for three months (24 sessions). BTSCS is designed to address the cognitive, motivational, and social support problems characteristic of people with SPMI. We propose to conduct a randomized clinical trial comparing BTSCS to a standard smoking cessation treatment.
Specific Aims: To determine if BTSCS is more effective in producing abstinence from smoking than a manualized smoking cessation program that reflects current best practices (StSST).
Hypothesis 1: BTSCS will result in greater rates of abstinence than StSST as shown by:
- A higher percentage of negative expired carbon monoxide levels at biweekly treatment sessions
- Increased days of abstinence reported at biweekly treatment sessions
- A higher percentage of negative expired carbon monoxide levels immediately post-treatment.
- A higher percentage of participants reporting abstinence in the 7-day interval preceding the post-treatment assessment.
Secondary Aims: We will assess the effectiveness of BTSCS on a set of intermediate outcomes including a reduction in smoking severity and improvement in readiness to quit smoking among smokers who have not been able to quit. We will also assess if increased treatment attendance and use of NRT's and bupropion moderate the hypothesized increases in abstinence.
- Conditions
- Schizoaffective Disorder, Schizophrenia, Affective Psychosis, Bipolar, Affective Disorders, Psychotic
- Being tested
- BTSCS, StSST
- Keywords
- smoking cessation, serious mental illness
- Medical subject headings
- Psychotic Disorders, Schizophrenia, Bipolar Disorder, Affective Disorders, Psychotic, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BTSCSBehavioural
BTSCS lasts 3 months, includes two 60-minute group meetings per week (24 group meetings total), and is delivered in small groups of 4-8 participants run by a trained interventionist. BTSCS includes: (1) An individual motivational enhancement meeting during the first week of treatment to help participants think about individual reasons for smoking cessation; (2) Breath carbon monoxide monitoring and goal-setting at the beginning of each meeting; (3) Skills for reducing smoking; (4) Social Skills Training; (5) Education about the biology of SPMI and smoking and the physiological harm caused by smoking; (5) Relapse prevention training; (6) Education about and assistance with nicotine replacement therapy for participants who are interested in learning about and trying it.
StSSTBehavioural
The StSST program is adapted from a 9-session weekly smoking cessation group program developed at the Outpatient Research Program of the Maryland Psychiatric Research Center and designed for people with schizophrenia. In this study, the StSST program meet twice per week for 3 months (24 sessions total). Participants complete a breath carbon monoxide (CO) test at the start of each group. StSST groups provide education about smoking and support for quitting.
| Study group | Role | What they receive |
|---|---|---|
| BTSCS | Experimental | BTSCS lasts 3 months, includes two 60-minute group meetings per week (24 group meetings total), and is delivered in small groups of 4-8 participants run by a trained interventionist. BTSCS includes: (1) An individual motivational enhancement meeting during the first week of treatment to help participants think about individual reasons for smoking cessation; (2) Breath carbon monoxide monitoring and goal-setting at the beginning of each meeting; (3) Skills for reducing smoking; (4) Social Skills Training; (5) Education about the biology of SPMI and smoking and the physiological harm caused by smoking; (5) Relapse prevention training; (6) Education about and assistance with nicotine replacement therapy for participants who are interested in learning about and trying it. Receives: Behavioral: BTSCS |
| StSST | Active comparator | The StSST program is adapted from a 9-session weekly smoking cessation group program developed at the Outpatient Research Program of the Maryland Psychiatric Research Center and designed for people with schizophrenia. In this study, the StSST program meet twice per week for 3 months (24 sessions total). Participants complete a breath carbon monoxide test at the start of each group meeting. StSST groups provide education about smoking and support for quitting. Receives: Behavioral: StSST |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Cigarettes Smoked Per Day
Number of cigarettes smoked per day for the last 7 days
Measured: day
Abstinence From Tobacco
Self-reported abstinence from tobacco + breath CO < 10 ppm
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2009 (estimated)
- Study startApr 2010
- Primary completionMar 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Schizoaffective DisorderStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 179 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Melanie E Bennett, Principal investigator, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00960375
- Sponsor's protocol ID
- NURA-001-09S
- Status last verified
- Jul 2015
- First submitted
- 14 Aug 2009
- Last updated
- 18 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Bennett ME, Brown CH, Li L, Himelhoch S, Bellack A, Dixon L. Smoking Cessation in Individuals With Serious Mental Illness: A Randomized Controlled Trial of Two Psychosocial Interventions. J Dual Diagn. 2015;11(3-4):161-73. doi: 10.1080/15504263.2015.1104481.
PubMed 26457385
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of a Smoking Cessation Program for Persons With SMI
- ClinicalTrials.gov ID
- NCT00960375
- Acronym / sponsor ID
- NURA-001-09S
- Conditions
- Schizoaffective Disorder, Schizophrenia, Affective Psychosis, Bipolar, Affective Disorders, Psychotic
- Keywords
- smoking cessation, serious mental illness
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 179 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Apr 2010
- Primary completion
- Mar 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 17 Aug 2009 (estimated)
- Results
- Posted 23 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators have developed an intervention called Behavioral Treatment of Smoking Cessation in SPMI (BTSCS), an innovative intervention that supplements pharmacotherapy and education with contingency management and a multifaceted behavioral group treatment program that lasts for three months (24 group meetings). BTSCS is designed to address the cognitive, motivational, and social support problems characteristic of people with SPMI.
The investigators propose to conduct a randomized trial for persons with SPMI that compares (1) BTSCS: a 6-month manualized smoking cessation program adapted from an effective substance abuse treatment program for this population to (2) StSST: a standard manualized smoking cessation program which reflects current best practices.
Detailed description
Smoking is the leading cause of preventable death in the United States. Smoking contributes to increased rates of diseases such as lung cancer and heart disease, and adds dangerous complications to health problems such as diabetes and obesity. Despite widespread recognition of the devastating health effects of smoking, over 70% of people with schizophrenia and other serious and persistent mental illnesses (SPMI) smoke cigarettes, a rate that is at least double that of the general population and remains high despite decreases in rates of smoking in the general population. These extraordinary smoking rates contribute to elevated morbidity and mortality, have other life-threatening health-related consequences, and increase health care costs for treating smoking related illnesses in this population. Treating smoking is critical in improving the health of people with SPMI.
The newly revised VA/Department of Defense Clinical Practice Guideline for the Management of Tobacco Use outlines the VHA's comprehensive program for smoking cessation. Beginning in 1997, the VA central office directed that the Agency for Health Care Policy and Research (AHCPR) smoking cessation guideline (the 5 A's - Ask, Advise, Assess, Assist, Arrange) be implemented in all its health care facilities. Reinforcing their commitment to increasing veterans' access to evidence-based smoking cessation interventions, the VHA recently released a new policy mandating that smoking cessation treatment be made available without restriction at all VA sites. Our previous study implementing the 5A's in community mental health clinics has found reduced smoking and increased use of smoking cessation aids such as nicotine replacement therapy (NRT), but no only modest increases in abstinence. Implementation of the 5 A's was limited by inability to adequately assist patients to stop smoking. Consideration of how best to supplement the "Assist" and "Arrange" phases reveals the troubling observation that existing "best practice" treatments for smoking cessation have limited effectiveness for persons with SPMI. The most widely tested treatments consist generally of adaptations of American Lung Association (ALA) or comparable 10-14 session weekly groups supplemented by either nicotine replacement therapy (NRT) or Bupropion. Such programs produce low abstinence rates (0-25%) at end of intervention. Sustained abstinence is virtually non-existent. Abstinence at 6-month or 1-year follow-up points ranges from 0-10%.
We have developed an intervention the treatment of cocaine and heroin use disorders among persons with SPMI, called Behavioral Treatment for Substance Abuse in Serious and Persistent Mental Illness (BTSAS). BTSAS was developed with a series of National Institute on Drug Abuse (NIDA-funded treatment development grants as a treatment program for substance abuse that accommodated the cognitive and motivational impairments that characterize SPMI. The goal was to incorporate strategies that have been found to be effective in reducing drug use more generally, but to tailor them to meet the needs of people with SPMI. BTSAS provides a model for this application's test of an innovative smoking cessation treatment. Our basic premise is that we must first acknowledge nicotine dependence as an addiction with characteristics common to other substance addictions, and then specify the additional biological, social, cognitive, psychological and environmental barriers to quitting smoking for people with SPMI. We must then fully optimize available technologies for addiction in general and smoking cessation in particular to address these deficits. Existing approaches to smoking cessation for persons with SPMI do not use the full range of biological, contingency management, social modeling and behavioral tools that have been shown to work in treating other addictions in this population. Further, research on treatment of substance use disorders in persons with SPMI has suggested that, for best outcomes, interventions may need to be more intensive that what is provided for other groups of substance abusers. Applied to smoking, this suggests that for people with SPMI, smoking cessation may need to be more intensive than the 9 weekly sessions typical of conventional smoking cessation programs.
Based on our work developing BTSAS, and the above features of smoking in SPMI, we have developed an intervention called Behavioral Treatment of Smoking Cessation in SPMI (BTSCS), an innovative intervention that supplements pharmacotherapy and education with breath carbon monoxide monitoring and a multifaceted behavioral group treatment program that lasts for three months (24 sessions). BTSCS is designed to address the cognitive, motivational, and social support problems characteristic of people with SPMI. We propose to conduct a randomized clinical trial comparing BTSCS to a standard smoking cessation treatment.
Specific Aims: To determine if BTSCS is more effective in producing abstinence from smoking than a manualized smoking cessation program that reflects current best practices (StSST).
Hypothesis 1: BTSCS will result in greater rates of abstinence than StSST as shown by:
- A higher percentage of negative expired carbon monoxide levels at biweekly treatment sessions
- Increased days of abstinence reported at biweekly treatment sessions
- A higher percentage of negative expired carbon monoxide levels immediately post-treatment.
- A higher percentage of participants reporting abstinence in the 7-day interval preceding the post-treatment assessment.
Secondary Aims: We will assess the effectiveness of BTSCS on a set of intermediate outcomes including a reduction in smoking severity and improvement in readiness to quit smoking among smokers who have not been able to quit. We will also assess if increased treatment attendance and use of NRT's and bupropion moderate the hypothesized increases in abstinence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BTSCS | Experimental | Behavioral: BTSCSBTSCS lasts 3 months, includes two 60-minute group meetings per week (24 group meetings total), and is delivered in small groups of 4-8 participants run by a trained interventionist. BTSCS includes: (1) An individual motivational enhancement meeting during the first week of treatment to help participants think about individual reasons for smoking cessation; (2) Breath carbon monoxide monitoring and goal-setting at the beginning of each meeting; (3) Skills for reducing smoking; (4) Social Skills Training; (5) Education about the biology of SPMI and smoking and the physiological harm caused by smoking; (5) Relapse prevention training; (6) Education about and assistance with nicotine replacement therapy for participants who are interested in learning about and trying it. |
| StSST | Active comparator | Behavioral: StSSTThe StSST program is adapted from a 9-session weekly smoking cessation group program developed at the Outpatient Research Program of the Maryland Psychiatric Research Center and designed for people with schizophrenia. In this study, the StSST program meet twice per week for 3 months (24 sessions total). Participants complete a breath carbon monoxide test at the start of each group meeting. StSST groups provide education about smoking and support for quitting. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- DSM-IV diagnosis of severe and persistent mental illness (SPMI) including a diagnosis of a psychotic disorder in keeping with criteria established by the Serious Mental Illness Treatment Research and Evaluation Center (SMITREC) -Schizophrenic disorders, affective psychoses and other psychotic diagnoses. We also include individuals with a diagnosis of Major Depression with psychotic features and PTSD.
- Age 18-75
- Nicotine dependence as defined by a score of 5 or higher on the Fagerstrom Tolerance Scale OR Participants who currently smoke at least 10 cigarettes per day
- Participants will not meet criteria for current alcohol/substance dependence (other than nicotine)
- Willingness ability to provide consent to participate.
Key exclusion criteria (2 listed)
- Documented history of severe neurological disorder or severe head trauma with loss of consciousness
- Severe or profound mental retardation by chart review.
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 |
|---|---|---|
| BTSCSBTSCS lasts 3 months, includes two 60-minute group meetings per week (24 group meetings total), and is delivered in small groups of 4-8 participants run by a trained interventionist. BTSCS includes: (1) An individual motivational enhancement meeting during the first week of treatment to help participants think about individual reasons for smoking cessation; (2) Breath carbon monoxide monitoring and goal-setting at the beginning of each meeting; (3) Skills for reducing smoking; (4) Social Skills Training; (5) Education about the biology of SPMI and smoking and the physiological harm caused by smoking; (5) Relapse prevention training; (6) Education about and assistance with nicotine replacement therapy for participants who are interested in learning about and trying it. | Behavioural | BTSCS |
| StSSTThe StSST program is adapted from a 9-session weekly smoking cessation group program developed at the Outpatient Research Program of the Maryland Psychiatric Research Center and designed for people with schizophrenia. In this study, the StSST program meet twice per week for 3 months (24 sessions total). Participants complete a breath carbon monoxide (CO) test at the start of each group. StSST groups provide education about smoking and support for quitting. | Behavioural | StSST |
Primary outcome
Number of Cigarettes Smoked Per Day
Time frame: day
Number of cigarettes smoked per day for the last 7 days
Abstinence From Tobacco
Time frame: 7 days
Self-reported abstinence from tobacco + breath CO < 10 ppm
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26457385Bennett ME, Brown CH, Li L, Himelhoch S, Bellack A, Dixon L. Smoking Cessation in Individuals With Serious Mental Illness: A Randomized Controlled Trial of Two Psychosocial Interventions. J Dual Diagn. 2015;11(3-4):161-73. doi: 10.1080/15504263.2015.1104481.
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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.
Melanie E Bennett principal investigator
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing BTSCS and StSST in people with Schizoaffective Disorder and Schizophrenia, run by US Department of Veterans Affairs at 2 sites 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 5 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 18 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Cigarettes Smoked Per Day (time frame: day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00960375, which also lists 1 linked publication.
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 Aug 2015.