SmokingNCT03931772
Online Automated Self-Hypnosis Program
A study testing Automated Self-Hypnosis in people with Smoking and Pain, run by Stanford University at 2 sites in United States.
Trial summary
After developing professional quality materials (audio) for an affordable automated self-hypnosis intervention program for facilitating smoking cessation, stress and pain reduction, researchers aim to gain qualitative reviews of this program, and test its initial feasibility and effects on smoking cessation and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Automated Self-Hypnosis
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Sep 2017to 25 Feb 2022
- Phase
- Interventional
- 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
- 18 years or older
- Able to read and understand English
- For the smokers, desire to quit smoking (specifically, report a motivation of ≥ 5 out of 10 to quit smoking on a 10-point Likert-type scale), and report being a daily smoker for at least one year, smoking an average ≥ 5 cigarettes per day
- For the pain group, report suffering from chronic pain syndromes, such as fibromyalgia or chronic low back pain
- For the stress group, report experiencing moderate to extreme stress or anxiety in the past month
- Having access to wireless internet connection or mobile data
Who cannot join
- Meeting criteria for drug abuse, including use of dissociative anesthetics, hallucinogens, opioids, cocaine, or amphetamine within the last 3 months
- Severe psychiatric or structural brain disease (i.e. psychosis, stroke with functional impairment, dementia) or current/recent risk to self
- Hearing impairment that would impede ability to listen the auditory intervention
- Major illnesses impacting the study results
- For smokers, currently taking Wellbutrin, Chantix, or other pharmacological smoking cessation aids that could confound results of the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Stanford Medicine - Psychiatry and Behavioral Sciences
Palo Alto, California, 94304
Dept. of Psychiatry, Stanford University
Stanford, California, 94305
About this study
Official title: Pilot Study Evaluating the Feasibility and Effects of an Innovative Automated Hypnosis Intervention for Smoking Cessation and Pain and Stress Reduction
After developing professional quality materials (audio) for an affordable automated self-hypnosis intervention program for facilitating smoking cessation, stress and pain reduction, researchers aim to gain qualitative reviews of this program, and test its initial feasibility and effects on smoking cessation and reduction in pain and stress.
In addition, this study seeks to determine whether higher hypnotizability, as measured by the Hypnotic Induction Profile (assessed at baseline), is a moderator of improved outcome in these conditions.
Read the detailed description
The investigators are interested in recruiting individuals who report that they smoke cigarettes daily and are motivated to make a serious attempt at quitting, and individuals who report experiencing pain or stress, who are willing to try to use the hypnosis intervention and provide feedback regarding their experience with the intervention.
The original intervention is an interactive hypnosis tool, developed by Reveri Health, utilizing periodic questions and answers to personalize the session progression and emulate the conversational nature of an in-person session designed based upon decades of clinical hypnosis research and experience at the Stanford Center on Stress and Health. The intervention is delivered through the Amazon Alexa platform's beta testing tool. Participants will be provided with the Alexa Dot device, which is sold by Amazon and widely used by consumers. Later on, research participants will have the option of using an Alexa-supported smartphone device without the Alexa Dot speaker. Those enrolled later in the study will instead be offered the use of the interactive app also developed by Reveri (www.reveri.com) independent of the Alexa platform. What will be specific to this pilot is the hypnosis training approach, including the interactive nature of the program. The structure and the content of the hypnosis training program will be the same across the 3 mentioned modes of administration. The user interface for the app is the main difference.
- Being tested
- Automated Self-Hypnosis
- Medical subject headings
- Smoking, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated Self-HypnosisBehavioural
Self-Hypnosis will be delivered through an interactive application administered through Amazon Alexa or Reveri.com.
| Study group | Role | What they receive |
|---|---|---|
| Automated Self-Hypnosis Intervention for Smoking Cessation | Experimental | Participants will first try this intervention at their Baseline visit following an assessment of trait hypnotizability. After being guided through the program by their experimenter (i.e., set-up procedures in addition to the actual hypnotic exercise) participants will provide initial feedback on the program through a series of questions. The entire appointment will take approximately one hour and will take place at The Center on Stress and Health. Participants will be provided with the Amazon Alexa device to take home (necessary for using the program), or the interactive Reveri (www.reveri.com) mobile app. After the lab visit participants will continue using the intervention at home as needed throughout the 24 months of study participation (recommended every few hours or whenever they feel the urge to smoke). Furthermore, participants will be taking an online 15-minute survey at the baseline visit, and then 1, 3, 6, 12 and 24-month online follow-up surveys at home. Receives: Behavioral: Automated Self-Hypnosis |
| Automated Self-Hypnosis Intervention for Pain Reduction | Experimental | Participants will first try this intervention at their Baseline visit following an assessment of trait hypnotizability. After being guided through the program by their experimenter (i.e., set-up procedures in addition to the actual hypnotic exercise) participants will provide initial feedback on the program through a series of questions. The entire appointment will take approximately one hour and will take place at The Center on Stress and Health, or remotely during the COVID-19 pandemic. Participants will be provided with the Amazon Alexa device to take home (necessary for using the program), or the interactive Reveri (www.reveri.com) mobile app. After the lab or remote visit participants will continue using the intervention at home as needed (recommended every few hours or whenever they experience an increase in pain). Furthermore, participants will be taking an online 15-minute survey at the baseline visit, and then 1, 3, 6, 12 and 24-month online follow-up surveys at home. Receives: Behavioral: Automated Self-Hypnosis |
| Automated Self-Hypnosis Intervention for Stress Reduction | Experimental | Participants will first try this intervention at their Baseline visit following an assessment of trait hypnotizability. After being guided through the program by their experimenter (i.e., set-up procedures in addition to the actual hypnotic exercise) participants will provide initial feedback on the program through a series of questions. The entire appointment will take approximately one hour and will take place at The Center on Stress and Health, or remotely during the COVID-19 pandemic. Participants will be provided with the Amazon Alexa device to take home (necessary for using the program), or the interactive Reveri (www.reveri.com) mobile app. After the lab or remote visit participants will continue using the intervention at home as needed (recommended every few hours or whenever they experience an increase in stress). Furthermore, participants will be taking an online 15-minute survey at the baseline visit, and then 1, 3, 6, 12 and 24-month online follow-up surveys at home. Receives: Behavioral: Automated Self-Hypnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Self-reported smoking cessation
The question, with a dichotomous (yes/no) response, "Have you succeeded in stopping smoking completely?" will be asked via online survey. Researchers will use responses of "Yes" to indicate abstinence.
Measured: Baseline through month 24
Change in Brief Pain Inventory-Pain Interference Score
Participant-reported outcome. Scores range from 0-10 and higher scores indicate worst pain.
Measured: Baseline through month 24
Change in Brief Pain Inventory-Pain Severity Score
Participant-reported outcome. Scores range from 0-10 and higher scores indicate worst pain.
Measured: Baseline through month 24
Change in McGill Pain Questionnaire
Participant-reported outcome. Scores range from 0-78 and the higher the pain score the greater the pain.
Measured: Baseline through month 24
Change in PROMIS SF v1.0 Pain Interference 4a short form
Participant-reported raw scores are converted to T-scores where T = 50 is the population mean and T = 40 and 60 are 1 SD below and above the population mean respectively. Higher T scores indicate higher pain.
Measured: Baseline through month 24
Change in PROMIS Global Pain Intensity (Pain Intensity 1a)
Participant-reported outcome. Scores range from 0 (no pain) to 10 (Worst imaginable pain).
Measured: Baseline through month 24
Change in Perceived Stress Scale
Participant-reported outcome. Scores range from 10-50; higher scores indicate higher stress.
Measured: Baseline through month 24
Change in Stanford Acute Stress Reaction Questionnaire
Participant-reported outcome. Scores range from 0 to 150 with higher scores indicating higher acute stress.
Measured: Baseline through month 24
Change in Impact of Event Scale - Revised
Participant-reported outcome evaluating subjective stress caused by traumatic events, where scores range from 0-88 and higher scores indicate higher subjective stress.
Measured: Baseline through month 24
Change in Positive and Negative Affect Scale-Negative Affect Scale Score
Participant-reported outcome. This reporting tool has positive and negative affect scales; the negative affect scale is a primary outcome measure in this study. Scores range from 10-50 and higher scores indicate higher negative affect.
Measured: Baseline through month 24
Change in State-Trait Anxiety Inventory Form X
Participant-reported outcome. Scores range from 20-80 and higher scores indicate higher state anxiety.
Measured: Baseline through month 24
Change in State-Trait Anxiety Inventory Form Y
Participant-reported outcome. Scores range from 20-80 and higher scores indicate higher trait anxiety.
Measured: Baseline through month 24
Secondary outcomes (10)
Rate of smoking reduction over time
Change in the number of self-reported daily cigarettes smoked at follow-ups will be examined.
Measured: Baseline through month 24
Change in PROMIS SF v1.0 Physical Function 4a short form
Participant-reported raw scores are converted to T-scores where T = 50 is the population mean and T = 40 and 60 are 1 SD below and above the population mean respectively. Higher T scores indicate higher physical function.
Measured: Baseline through month 24
Change in PROMIS SF v1.0 Anxiety 4a short form
Participant-reported raw scores are converted to T-scores where T = 50 is the population mean and T = 40 and 60 are 1 SD below and above the population mean respectively. Higher T scores indicate higher anxiety.
Measured: Baseline through month 24
Change in PROMIS SF v1.0 Depression 4a short form
Participant-reported raw scores are converted to T-scores where T = 50 is the population mean and T = 40 and 60 are 1 SD below and above the population mean respectively. Higher T scores indicate higher depression.
Measured: Baseline through month 24
Change in PROMIS SF v1.0 Fatigue 4a short form
Participant-reported raw scores are converted to T-scores where T = 50 is the population mean and T = 40 and 60 are 1 SD below and above the population mean respectively. Higher T scores indicate higher fatigue.
Measured: Baseline through month 24
Change in PROMIS SF v1.0 Sleep Disturbance 4a short form
Participant-reported raw scores are converted to T-scores where T = 50 is the population mean and T = 40 and 60 are 1 SD below and above the population mean respectively. Higher T scores indicate higher sleep disturbance.
Measured: Baseline through month 24
Change in PROMIS SF v1.0 Ability to Participate in Social Roles and Activities 4a short form
Participant-reported raw scores are converted to T-scores where T = 50 is the population mean and T = 40 and 60 are 1 SD below and above the population mean respectively. Higher T scores indicate higher ability to participate in social roles and activities.
Measured: Baseline through month 24
Change in Positive and Negative Affect Scale-Positive Affect Scale Score
Participant-reported outcome. This reporting tool has positive and negative affect scales; the positive affect scale is a secondary outcome measure in this study. Scores range from 10-50 and higher scores indicate higher positive affect.
Measured: Baseline through month 24
Change in Brief Cope Scale
Participant-reported outcome. Scores range from 2-8 and higher scores indicate greater ability to cope.
Measured: Baseline through month 24
Change in Pittsburgh Sleep Quality Index
Participant-reported outcome of change in sleep quality. Scores range from 0-21 and higher scores indicate worse sleep quality.
Measured: Baseline through month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study start5 Sep 2017
- Primary completion25 Feb 2022
- Study completion25 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Stanford 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 N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- This is a pilot, open trial evaluating a novel automated hypnosis intervention for smoking cessation and pain and reduction
- Masking
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Spiegel, Stanford University
- Investigators
- David Spiegel, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03931772
- Sponsor's protocol ID
- 42124
- Status last verified
- Mar 2023
- First submitted
- 2 Apr 2019
- Last updated
- 20 Mar 2023
- Results posted
- No
- 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 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Evaluating the Feasibility and Effects of an Innovative Automated Hypnosis Intervention for Smoking Cessation and Pain and Stress Reduction
- ClinicalTrials.gov ID
- NCT03931772
- Acronym / sponsor ID
- 42124
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- 5 Sep 2017 (actual)
- Primary completion
- 25 Feb 2022 (actual)
- Study completion
- 25 Feb 2022 (actual)
- First posted
- 30 Apr 2019 (actual)
- 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.
After developing professional quality materials (audio) for an affordable automated self-hypnosis intervention program for facilitating smoking cessation, stress and pain reduction, researchers aim to gain qualitative reviews of this program, and test its initial feasibility and effects on smoking cessation and reduction in pain and stress.
In addition, this study seeks to determine whether higher hypnotizability, as measured by the Hypnotic Induction Profile (assessed at baseline), is a moderator of improved outcome in these conditions.
Detailed description
The investigators are interested in recruiting individuals who report that they smoke cigarettes daily and are motivated to make a serious attempt at quitting, and individuals who report experiencing pain or stress, who are willing to try to use the hypnosis intervention and provide feedback regarding their experience with the intervention.
The original intervention is an interactive hypnosis tool, developed by Reveri Health, utilizing periodic questions and answers to personalize the session progression and emulate the conversational nature of an in-person session designed based upon decades of clinical hypnosis research and experience at the Stanford Center on Stress and Health. The intervention is delivered through the Amazon Alexa platform's beta testing tool. Participants will be provided with the Alexa Dot device, which is sold by Amazon and widely used by consumers. Later on, research participants will have the option of using an Alexa-supported smartphone device without the Alexa Dot speaker. Those enrolled later in the study will instead be offered the use of the interactive app also developed by Reveri (www.reveri.com) independent of the Alexa platform. What will be specific to this pilot is the hypnosis training approach, including the interactive nature of the program. The structure and the content of the hypnosis training program will be the same across the 3 mentioned modes of administration. The user interface for the app is the main difference.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a pilot, open trial evaluating a novel automated hypnosis intervention for smoking cessation and pain and reduction
| Arm | Type | Receives |
|---|---|---|
| Automated Self-Hypnosis Intervention for Smoking Cessation | Experimental | Behavioral: Automated Self-HypnosisParticipants will first try this intervention at their Baseline visit following an assessment of trait hypnotizability. After being guided through the program by their experimenter (i.e., set-up procedures in addition to the actual hypnotic exercise) participants will provide initial feedback on the program through a series of questions. The entire appointment will take approximately one hour and will take place at The Center on Stress and Health. Participants will be provided with the Amazon Alexa device to take home (necessary for using the program), or the interactive Reveri (www.reveri.com) mobile app. After the lab visit participants will continue using the intervention at home as needed throughout the 24 months of study participation (recommended every few hours or whenever they feel the urge to smoke). Furthermore, participants will be taking an online 15-minute survey at the baseline visit, and then 1, 3, 6, 12 and 24-month online follow-up surveys at home. |
| Automated Self-Hypnosis Intervention for Pain Reduction | Experimental | Behavioral: Automated Self-HypnosisParticipants will first try this intervention at their Baseline visit following an assessment of trait hypnotizability. After being guided through the program by their experimenter (i.e., set-up procedures in addition to the actual hypnotic exercise) participants will provide initial feedback on the program through a series of questions. The entire appointment will take approximately one hour and will take place at The Center on Stress and Health, or remotely during the COVID-19 pandemic. Participants will be provided with the Amazon Alexa device to take home (necessary for using the program), or the interactive Reveri (www.reveri.com) mobile app. After the lab or remote visit participants will continue using the intervention at home as needed (recommended every few hours or whenever they experience an increase in pain). Furthermore, participants will be taking an online 15-minute survey at the baseline visit, and then 1, 3, 6, 12 and 24-month online follow-up surveys at home. |
| Automated Self-Hypnosis Intervention for Stress Reduction | Experimental | Behavioral: Automated Self-HypnosisParticipants will first try this intervention at their Baseline visit following an assessment of trait hypnotizability. After being guided through the program by their experimenter (i.e., set-up procedures in addition to the actual hypnotic exercise) participants will provide initial feedback on the program through a series of questions. The entire appointment will take approximately one hour and will take place at The Center on Stress and Health, or remotely during the COVID-19 pandemic. Participants will be provided with the Amazon Alexa device to take home (necessary for using the program), or the interactive Reveri (www.reveri.com) mobile app. After the lab or remote visit participants will continue using the intervention at home as needed (recommended every few hours or whenever they experience an increase in stress). Furthermore, participants will be taking an online 15-minute survey at the baseline visit, and then 1, 3, 6, 12 and 24-month online follow-up surveys at home. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18 years or older
- Able to read and understand English
- For the smokers, desire to quit smoking (specifically, report a motivation of ≥ 5 out of 10 to quit smoking on a 10-point Likert-type scale), and report being a daily smoker for at least one year, smoking an average ≥ 5 cigarettes per day
- For the pain group, report suffering from chronic pain syndromes, such as fibromyalgia or chronic low back pain
- For the stress group, report experiencing moderate to extreme stress or anxiety in the past month
Key exclusion criteria (5 listed)
- Meeting criteria for drug abuse, including use of dissociative anesthetics, hallucinogens, opioids, cocaine, or amphetamine within the last 3 months
- Severe psychiatric or structural brain disease (i.e. psychosis, stroke with functional impairment, dementia) or current/recent risk to self
- Hearing impairment that would impede ability to listen the auditory intervention
- Major illnesses impacting the study results
- For smokers, currently taking Wellbutrin, Chantix, or other pharmacological smoking cessation aids that could confound results of the study
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 |
|---|---|---|
| Automated Self-HypnosisSelf-Hypnosis will be delivered through an interactive application administered through Amazon Alexa or Reveri.com. | Behavioural | Automated Self-Hypnosis Intervention for Pain Reduction, Automated Self-Hypnosis Intervention for Smoking Cessation, Automated Self-Hypnosis Intervention for Stress Reduction |
Primary outcome
Rate of Self-reported smoking cessation
Time frame: Baseline through month 24
The question, with a dichotomous (yes/no) response, "Have you succeeded in stopping smoking completely?" will be asked via online survey. Researchers will use responses of "Yes" to indicate abstinence.
Change in Brief Pain Inventory-Pain Interference Score
Time frame: Baseline through month 24
Participant-reported outcome. Scores range from 0-10 and higher scores indicate worst pain.
Change in Brief Pain Inventory-Pain Severity Score
Time frame: Baseline through month 24
Participant-reported outcome. Scores range from 0-10 and higher scores indicate worst pain.
Change in McGill Pain Questionnaire
Time frame: Baseline through month 24
Participant-reported outcome. Scores range from 0-78 and the higher the pain score the greater the pain.
Change in PROMIS SF v1.0 Pain Interference 4a short form
Time frame: Baseline through month 24
Participant-reported raw scores are converted to T-scores where T = 50 is the population mean and T = 40 and 60 are 1 SD below and above the population mean respectively. Higher T scores indicate higher pain.
Change in PROMIS Global Pain Intensity (Pain Intensity 1a)
Time frame: Baseline through month 24
Participant-reported outcome. Scores range from 0 (no pain) to 10 (Worst imaginable pain).
Change in Perceived Stress Scale
Time frame: Baseline through month 24
Participant-reported outcome. Scores range from 10-50; higher scores indicate higher stress.
Change in Stanford Acute Stress Reaction Questionnaire
Time frame: Baseline through month 24
Participant-reported outcome. Scores range from 0 to 150 with higher scores indicating higher acute stress.
Change in Impact of Event Scale - Revised
Time frame: Baseline through month 24
Participant-reported outcome evaluating subjective stress caused by traumatic events, where scores range from 0-88 and higher scores indicate higher subjective stress.
Change in Positive and Negative Affect Scale-Negative Affect Scale Score
Time frame: Baseline through month 24
Participant-reported outcome. This reporting tool has positive and negative affect scales; the negative affect scale is a primary outcome measure in this study. Scores range from 10-50 and higher scores indicate higher negative affect.
Change in State-Trait Anxiety Inventory Form X
Time frame: Baseline through month 24
Participant-reported outcome. Scores range from 20-80 and higher scores indicate higher state anxiety.
Change in State-Trait Anxiety Inventory Form Y
Time frame: Baseline through month 24
Participant-reported outcome. Scores range from 20-80 and higher scores indicate higher trait anxiety.
10 secondary outcomes
Rate of smoking reduction over time
Time frame: Baseline through month 24
Change in PROMIS SF v1.0 Physical Function 4a short form
Time frame: Baseline through month 24
Change in PROMIS SF v1.0 Anxiety 4a short form
Time frame: Baseline through month 24
Change in PROMIS SF v1.0 Depression 4a short form
Time frame: Baseline through month 24
Change in PROMIS SF v1.0 Fatigue 4a short form
Time frame: Baseline through month 24
Change in PROMIS SF v1.0 Sleep Disturbance 4a short form
Time frame: Baseline through month 24
Change in PROMIS SF v1.0 Ability to Participate in Social Roles and Activities 4a short form
Time frame: Baseline through month 24
Change in Positive and Negative Affect Scale-Positive Affect Scale Score
Time frame: Baseline through month 24
Change in Brief Cope Scale
Time frame: Baseline through month 24
Change in Pittsburgh Sleep Quality Index
Time frame: Baseline through month 24
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 20 Mar 2023.
- 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.
David Spiegel, MD principal investigator
Stanford University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automated Self-Hypnosis in people with Smoking and Pain, run by Stanford University 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 6 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 20 Mar 2023. 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.
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?
Rate of Self-reported smoking cessation (time frame: Baseline through month 24). The study lists 12 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 20 Mar 2023.