Nicotine DependenceNCT02500589
Adjunctive Mood Management for Telephone-based Smoking Cessation
A study testing Behavioral mood management and Health education in people with Nicotine Dependence, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Smoking is the leading cause of morbidity and mortality in the U.S. Interventions that increase successful quit attempts among depressed smokers with chronic medical illnesses are particularly important for the VA healthcare system because rates of tobacco use, depression, and chronic medical illnesses are… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- Behavioral mood management and Health education
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2016to 19 Apr 2019
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients must meet all of the following inclusion criteria:
- 1.Enrolled in the Durham VAMC for ongoing care
- 2.Current tobacco smokers planning to quit smoking in the next 30 days
- 3.Having received a diagnosis of a qualifying chronic illness (i.e., cancer, cardiovascular disease, hypertension, diabetes, COPD)
- 4.Have significant burden of depressive symptoms (i.e., meets DSM threshold for > 3 of the nine MDD criterion symptoms at the threshold of "more than half the days" (one symptom must be depressed mood or anhedonia; endorsing "some days" meets criteria for self-harm) and endorse functional impairment OR receive a summary score 10 or above on PHQ-9.
Who cannot join
- Patients who meet any one of the following exclusion criteria will be excluded:
- 1.Active diagnosis of psychosis or dementia in their medical records
- 2.Severely impaired hearing or speech
- 3.Lack of telephone access
- 4.Enrollment in another research study that might affect the main outcomes of this study
- 5.Terminal illness
Show all 9Show fewer
- 6. Behavioral flag in medical record
- 7. Active suicidal ideation flag in medical record
- 8. Endorses thoughts of self-harm and is a greater than minimal risk of suicide
Trial locations and contacts
1 site in 1 country.
United States1 site
Durham VA Medical Center, Durham, NC
Durham, North Carolina, 27705-3875
About this study
Official title: Adjunctive Mood Management for Telephone-based Smoking Cessation in Primary Care
Smoking is the leading cause of morbidity and mortality in the U.S. Interventions that increase successful quit attempts among depressed smokers with chronic medical illnesses are particularly important for the VA healthcare system because rates of tobacco use, depression, and chronic medical illnesses are significantly higher among Veterans compared to the general population. Providing smoking cessation services augmented with mood management to Veterans via telephone may increase access to, and utilization of, evidence-based smoking cessation counseling and decrease rates of smoking-related complications for Veterans with chronic medical illnesses and depression. Yet, the reach of smoking cessation telephone counseling has been limited among populations with mental illness. The investigators intend to combine the potency of co-delivered mood management and reach of telephone-delivered interventions by testing the telephone delivery of behavioral mood-management for smoking cessation among smokers with depression and chronic medical illness.
Read the detailed description
Purpose: Cigarette smoking is the single greatest cause of preventable deaths. In the VA health care system, patients with chronic medical illnesses represent an important population on which to focus smoking cessation efforts. Smoking cessation among patients with chronic medical illnesses can substantially decrease morbidity and mortality. Despite these benefits, many patients with chronic medical illnesses continue to smoke. There is a strong interrelationship between depression and chronic medical illness. Depression can derail sustained smoking cessation and may be an important barrier to smoking cessation for Veterans with chronic medical illness. Despite the barriers they face, smokers with depression are motivated to quit smoking. Smokers with histories of depression may respond better to smoking cessation interventions that are augmented with mood-management adjuncts such as mood-management counseling. Thus, depressed smokers are more likely to quit when behavioral mood-management is added to traditional cessation approaches. Yet, the augmentation of smoking cessation with behavioral mood management is not yet firmly established. Also these intensive interventions have limited reach when conducted in person. Telephone counseling can deliver intensive and effective treatment to people who smoke, yet its implementation has been limited among smoker with depression. There is a need to develop novel proactive telephone-delivered approaches that can broadly deliver intensive smoking cessation interventions to Veterans who may not respond to standard care, such as those with chronic medical illnesses and depressive symptoms.
Methodology: The investigators propose a randomized comparative effectiveness trial with a two-group design in which 350 Veteran smokers with depression and chronic medical illness will be randomized to either: 1) smoking cessation plus adjunctive behavioral mood management (SMK-MM group), an intervention that includes a proactive telehealth intervention that combines evidence-based smoking cessation counseling augmented with behavioral mood management and a tele-medicine clinic for accessing nicotine replacement therapy (NRT), or 2) smoking cessation telephone counseling control (SMK CONTROL), a contact-equivalent control that provides the same smoking cessation telephone counseling intervention augmented with health education (instead of mood-management) and a tele-medicine clinic for accessing NRT. Patients with chronic medical illnesses will be identified from patient intake systems of the Durham Veteran's Affairs Hospital and screened for tobacco use and depressive symptoms.
The main outcome in this trial is prolonged abstinence at 6-month and 12-month follow-up. Logistic regression will be used to test for a between-group difference in the proportion of patients with self-reported prolonged abstinence from cigarettes at 6 months. A general linear mixed model will be used to estimate changes depressive symptoms between groups. If there is a significant intervention effect on smoking cessation, mediational analysis will be conducted to examine whether changes in self-efficacy or affect mediate the impact of the mood management intervention.
Objectives: The specific aims of the study are to 1) evaluate the impact of a telephone-delivered smoking cessation intervention augmented with behavioral mood management on rates of prolonged and point prevalence abstinence from cigarettes among Veterans with chronic medical illnesses and depression; 2) monitor the impact of behavioral mood management intervention on depressive symptoms; 3) if effective, assess whether change in self-efficacy as well as positive and negative affect mediate the impact of behavioral mood management intervention on smoking cessation among Veterans; and 4) assess the cost-effectiveness if the mood-enhanced intervention.
- Conditions
- Nicotine Dependence
- Being tested
- Behavioral mood management, Health education
- Keywords
- smoking, 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.
Behavioral mood managementBehavioural
The mood-management sessions are informed by CBT and emphasize psycho-educational and skills-based approaches to CBT. CBT has been used extensively to address mood management. Specifically, SMK-MM enhancement includes behavioral activation, cognitive restructuring (working with automatic thoughts, problem solving, and behavioral skills (i.e., activity scheduling, relaxation training/controlled breathing). The SMK-MM-enhanced participant manual will also include additional worksheets developed for the investigator's pilot based on Lewinsohn's self-help guide to controlling depression. The main objective of the worksheets will be to provide Veterans with an opportunity to gain mastery over selected behavioral and cognitive skills thought to facilitate mood management. As is customary in CBT, homework based on the worksheets will be discussed during counseling calls.
Health educationOther
In the contact-equivalent health education condition, participants will receive parallel smoking cessation content on the same schedule as in the MM-enhanced arm; however, health education content will supplant the MM content. The educational content will be based on the VA National Center on Health Promotion and Disease Prevention's "Health Living Messages" on such topics as being safe, eating wisely, getting recommended immunization and screening tests, and being involved with the participant's health care. Participants also will receive chronic-disease-specific self-management information.
| Study group | Role | What they receive |
|---|---|---|
| Mood management enhancement | Experimental | In the SMK-MM enhanced arm, behavioral mood management will be integrated into the evidence-based smoking cessation counseling. Receives: Behavioral: Behavioral mood management |
| Health education control | Other | In the contact-equivalent health education condition, participants will receive parallel smoking cessation content on the same schedule as in the MM-enhanced arm; however, health education content will supplant the MM content. The educational content will be based on the VA National Center on Health Promotion and Disease Prevention's "Health Living Messages" on such topics as being safe, eating wisely, getting recommended immunization and screening tests, and being involved with personal health care. Participants also will receive chronic-disease-specific self-management information. Receives: Other: Health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Prolonged Abstinence
In keeping with the Society for Research on Nicotine and Tobacco recommendations for measuring abstinence, the investigators use prolonged abstinence as the main outcome and allow for a grace period around quit date. During the 6-month follow-ups, patients will be asked about prolonged abstinence, "Since [end of the grace period] has the participant ever smoked at least a part of a cigarette on each of 7 consecutive days?" and "After [end of the grace period] has the participant smoked any in each of 2 consecutive weeks?" Responding "no" to these questions is considered having obtained prolonged abstinence (ie., smoking cessation). Data below reflect the participants responding "no."
Measured: 6 month
Number of Participants With Prolonged Abstinence
In keeping with the Society for Research on Nicotine and Tobacco recommendations for measuring abstinence, the investigators use prolonged abstinence as the main outcome and allow for a grace period around quit date. During the 12-month follow-ups, patients will be asked about prolonged abstinence, "Since [end of the grace period] has the participant ever smoked at least a part of a cigarette on each of 7 consecutive days?" and "After [end of the grace period] has the participant smoked any in each of 2 consecutive weeks?" Responding "no" to these questions is considered having obtained prolonged abstinence (ie., smoking cessation). Data below reflect the participants responding "no."
Measured: 12 month
Secondary outcomes (6)
Number of Participants With 7 Day Point Prevalent Abstinence
At each follow-up (6 month), participants will be asked whether they have smoked a cigarette, even a puff, in the past 7 days and, if no, will then be asked whether the participant has smoked a cigarette, even a puff, in the past 30 days. Data presented below represents those who self-reported not smoking.
Measured: Month 6
Change in PHQ-9 (Patient Depression Questionnaire) Score From Baseline to 6-months
Patients were asked the frequency with which they experienced symptoms indicative of depression in the past two weeks. This measure can be used to assess Diagnostic and Statistical Manual (DSM) criterion symptoms for Major Depressive Disorder (MDD), assess depression severity, and assess suicidal ideations. The Patient Health Questionnaire-9 (PHQ-9) performs similarly across sociodemographic groups (i.e., age, race, sex) and mode of administration (e.g., patient self-report). The PHQ-9 score can range from 0 to 27, with higher scores representing higher symptom burden. We calculated the change in PHQ-9 scores from baseline to 6 month follow-up assessment. Negative scores indicate a reduction in depression symptom burden.
Measured: change from baseline to 6 month follow up
Change in PHQ-9 (Patient Depression Questionnaire) Score From Baseline to 12 Month Follow up
Patients were asked the frequency with which they experienced symptoms indicative of depression in the past two weeks. This measure can be used to assess Diagnostic and Statistical Manual (DSM) criterion symptoms for Major Depressive Disorder (MDD), assess depression severity, and assess suicidal ideations. The Patient Health Questionnaire-9 (PHQ-9) performs similarly across sociodemographic groups (i.e., age, race, sex) and mode of administration (e.g., patient self-report). The PHQ-9 score can range from 0 to 27, with higher scores representing higher symptom burden. We calculated the change in PHQ-9 scores from baseline to 12 month follow-up assessment. Negative scores indicate a reduction in depression symptom burden.
Measured: change from baseline to 12 month follow up
Biochemical Verification of Smoking Cessation at 6 Month Follow up
Saliva samples will be collected from participants who report not smoking in the last 7 days to biochemically validate self-report smoking status. Samples will be collected by mail within a 2-week window following the telephone interview. Data presented below represents those who were confirmed to be not smoking at 6 months via biochemical validation of of saliva samples.
Measured: 6 month follow up
Number of Participants With 7 Day Point Prevalent Abstinence
At each follow-up (12-month), participants will be asked whether they have smoked a cigarette, even a puff, in the past 7 days and, if no, will then be asked whether the participant has smoked a cigarette, even a puff, in the past 30 days. Data presented below represents those who self-reported not smoking.
Measured: 12 month
Biochemical Verification of Smoking Cessation at 12 Month Follow up
Saliva samples will be collected from participants who report not smoking in the last 7 days to biochemically validate self-report smoking status. Samples will be collected by mail within a 2-week window following the telephone interview. Data presented below represents those who were confirmed to be not smoking at 12 months via biochemical validation of of saliva samples.
Measured: 12 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 posted16 Jul 2015 (estimated)
- Study start31 May 2016
- Primary completion19 Apr 2019
- Study completion19 Apr 2019
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.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jennifer M Gierisch, PhD MA, Principal investigator, Durham VA Medical Center, Durham, NC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02500589
- Sponsor's protocol ID
- IIR 11-300
- Status last verified
- Jul 2023
- First submitted
- 24 Jun 2015
- Last updated
- 27 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunctive Mood Management for Telephone-based Smoking Cessation in Primary Care
- ClinicalTrials.gov ID
- NCT02500589
- Acronym / sponsor ID
- IIR 11-300
- Conditions
- Nicotine Dependence
- Keywords
- smoking, tobacco
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 31 May 2016 (actual)
- Primary completion
- 19 Apr 2019 (actual)
- Study completion
- 19 Apr 2019 (actual)
- First posted
- 16 Jul 2015 (estimated)
- Results
- Posted 6 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Smoking is the leading cause of morbidity and mortality in the U.S. Interventions that increase successful quit attempts among depressed smokers with chronic medical illnesses are particularly important for the VA healthcare system because rates of tobacco use, depression, and chronic medical illnesses are significantly higher among Veterans compared to the general population. Providing smoking cessation services augmented with mood management to Veterans via telephone may increase access to, and utilization of, evidence-based smoking cessation counseling and decrease rates of smoking-related complications for Veterans with chronic medical illnesses and depression. Yet, the reach of smoking cessation telephone counseling has been limited among populations with mental illness. The investigators intend to combine the potency of co-delivered mood management and reach of telephone-delivered interventions by testing the telephone delivery of behavioral mood-management for smoking cessation among smokers with depression and chronic medical illness.
Detailed description
Purpose: Cigarette smoking is the single greatest cause of preventable deaths. In the VA health care system, patients with chronic medical illnesses represent an important population on which to focus smoking cessation efforts. Smoking cessation among patients with chronic medical illnesses can substantially decrease morbidity and mortality. Despite these benefits, many patients with chronic medical illnesses continue to smoke. There is a strong interrelationship between depression and chronic medical illness. Depression can derail sustained smoking cessation and may be an important barrier to smoking cessation for Veterans with chronic medical illness. Despite the barriers they face, smokers with depression are motivated to quit smoking. Smokers with histories of depression may respond better to smoking cessation interventions that are augmented with mood-management adjuncts such as mood-management counseling. Thus, depressed smokers are more likely to quit when behavioral mood-management is added to traditional cessation approaches. Yet, the augmentation of smoking cessation with behavioral mood management is not yet firmly established. Also these intensive interventions have limited reach when conducted in person. Telephone counseling can deliver intensive and effective treatment to people who smoke, yet its implementation has been limited among smoker with depression. There is a need to develop novel proactive telephone-delivered approaches that can broadly deliver intensive smoking cessation interventions to Veterans who may not respond to standard care, such as those with chronic medical illnesses and depressive symptoms.
Methodology: The investigators propose a randomized comparative effectiveness trial with a two-group design in which 350 Veteran smokers with depression and chronic medical illness will be randomized to either: 1) smoking cessation plus adjunctive behavioral mood management (SMK-MM group), an intervention that includes a proactive telehealth intervention that combines evidence-based smoking cessation counseling augmented with behavioral mood management and a tele-medicine clinic for accessing nicotine replacement therapy (NRT), or 2) smoking cessation telephone counseling control (SMK CONTROL), a contact-equivalent control that provides the same smoking cessation telephone counseling intervention augmented with health education (instead of mood-management) and a tele-medicine clinic for accessing NRT. Patients with chronic medical illnesses will be identified from patient intake systems of the Durham Veteran's Affairs Hospital and screened for tobacco use and depressive symptoms.
The main outcome in this trial is prolonged abstinence at 6-month and 12-month follow-up. Logistic regression will be used to test for a between-group difference in the proportion of patients with self-reported prolonged abstinence from cigarettes at 6 months. A general linear mixed model will be used to estimate changes depressive symptoms between groups. If there is a significant intervention effect on smoking cessation, mediational analysis will be conducted to examine whether changes in self-efficacy or affect mediate the impact of the mood management intervention.
Objectives: The specific aims of the study are to 1) evaluate the impact of a telephone-delivered smoking cessation intervention augmented with behavioral mood management on rates of prolonged and point prevalence abstinence from cigarettes among Veterans with chronic medical illnesses and depression; 2) monitor the impact of behavioral mood management intervention on depressive symptoms; 3) if effective, assess whether change in self-efficacy as well as positive and negative affect mediate the impact of behavioral mood management intervention on smoking cessation among Veterans; and 4) assess the cost-effectiveness if the mood-enhanced intervention.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mood management enhancement | Experimental | Behavioral: Behavioral mood managementIn the SMK-MM enhanced arm, behavioral mood management will be integrated into the evidence-based smoking cessation counseling. |
| Health education control | Other | Other: Health educationIn the contact-equivalent health education condition, participants will receive parallel smoking cessation content on the same schedule as in the MM-enhanced arm; however, health education content will supplant the MM content. The educational content will be based on the VA National Center on Health Promotion and Disease Prevention's "Health Living Messages" on such topics as being safe, eating wisely, getting recommended immunization and screening tests, and being involved with personal health care. Participants also will receive chronic-disease-specific self-management information. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 1.Enrolled in the Durham VAMC for ongoing care
- 2.Current tobacco smokers planning to quit smoking in the next 30 days
- 3.Having received a diagnosis of a qualifying chronic illness (i.e., cancer, cardiovascular disease, hypertension, diabetes, COPD)
- 4.Have significant burden of depressive symptoms (i.e., meets DSM threshold for > 3 of the nine MDD criterion symptoms at the threshold of "more than half the days" (one symptom must be depressed mood or anhedonia; endorsing "some days" meets criteria for self-harm) and endorse functional impairment OR receive a summary score 10 or above on PHQ-9.
Key exclusion criteria (9 listed)
- 1.Active diagnosis of psychosis or dementia in their medical records
- 2.Severely impaired hearing or speech
- 3.Lack of telephone access
- 4.Enrollment in another research study that might affect the main outcomes of this study
- 5.Terminal illness
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 |
|---|---|---|
| Behavioral mood managementThe mood-management sessions are informed by CBT and emphasize psycho-educational and skills-based approaches to CBT. CBT has been used extensively to address mood management. Specifically, SMK-MM enhancement includes behavioral activation, cognitive restructuring (working with automatic thoughts, problem solving, and behavioral skills (i.e., activity scheduling, relaxation training/controlled breathing). The SMK-MM-enhanced participant manual will also include additional worksheets developed for the investigator's pilot based on Lewinsohn's self-help guide to controlling depression. The main objective of the worksheets will be to provide Veterans with an opportunity to gain mastery over selected behavioral and cognitive skills thought to facilitate mood management. As is customary in CBT, homework based on the worksheets will be discussed during counseling calls. | Behavioural | Mood management enhancement |
| Health educationIn the contact-equivalent health education condition, participants will receive parallel smoking cessation content on the same schedule as in the MM-enhanced arm; however, health education content will supplant the MM content. The educational content will be based on the VA National Center on Health Promotion and Disease Prevention's "Health Living Messages" on such topics as being safe, eating wisely, getting recommended immunization and screening tests, and being involved with the participant's health care. Participants also will receive chronic-disease-specific self-management information. | Other | Health education control |
Primary outcome
Number of Participants With Prolonged Abstinence
Time frame: 6 month
In keeping with the Society for Research on Nicotine and Tobacco recommendations for measuring abstinence, the investigators use prolonged abstinence as the main outcome and allow for a grace period around quit date. During the 6-month follow-ups, patients will be asked about prolonged abstinence, "Since [end of the grace period] has the participant ever smoked at least a part of a cigarette on each of 7 consecutive days?" and "After [end of the grace period] has the participant smoked any in each of 2 consecutive weeks?" Responding "no" to these questions is considered having obtained prolonged abstinence (ie., smoking cessation). Data below reflect the participants responding "no."
Number of Participants With Prolonged Abstinence
Time frame: 12 month
In keeping with the Society for Research on Nicotine and Tobacco recommendations for measuring abstinence, the investigators use prolonged abstinence as the main outcome and allow for a grace period around quit date. During the 12-month follow-ups, patients will be asked about prolonged abstinence, "Since [end of the grace period] has the participant ever smoked at least a part of a cigarette on each of 7 consecutive days?" and "After [end of the grace period] has the participant smoked any in each of 2 consecutive weeks?" Responding "no" to these questions is considered having obtained prolonged abstinence (ie., smoking cessation). Data below reflect the participants responding "no."
6 secondary outcomes
Number of Participants With 7 Day Point Prevalent Abstinence
Time frame: Month 6
Change in PHQ-9 (Patient Depression Questionnaire) Score From Baseline to 6-months
Time frame: change from baseline to 6 month follow up
Change in PHQ-9 (Patient Depression Questionnaire) Score From Baseline to 12 Month Follow up
Time frame: change from baseline to 12 month follow up
Biochemical Verification of Smoking Cessation at 6 Month Follow up
Time frame: 6 month follow up
Number of Participants With 7 Day Point Prevalent Abstinence
Time frame: 12 month
Biochemical Verification of Smoking Cessation at 12 Month Follow up
Time frame: 12 month follow up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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 M Gierisch, PhD MA principal investigator
Durham VA Medical Center, Durham, NC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral mood management and Health education in people with Nicotine Dependence, run by VA Office of Research and Development 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 5 inclusion and 9 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 Jul 2023. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Dec 2021). 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 Participants With Prolonged Abstinence (time frame: 6 month). 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?
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 Jul 2023; AzTrials last refreshed its copy on 30 Oct 2026.