Tobacco Use DisorderNCT05625685
Equitable Smoking Relapse Prevention
A study testing Quitbuddy and SDoH Augmentation in people with Tobacco Use Disorder and Tobacco Dependence, run by Bryan W. Heckman at 1 site in United States.
Trial summary
The goal of this clinical trial is to test a GPS (Global Positioning System)-enabled smartphone app (QuitBuddy) in current smokers. The main questions it aims to answer are: Is Quitbuddy a good treatment for quitting smoking and "staying quit"? Will a second treatment that connects people to help for their social and… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Disorder, Tobacco Dependence
- What is being tested?
- Quitbuddy and SDoH Augmentation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2023to 30 Nov 2023
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 21 years of age
- Smoking at least 10 cigarettes per day for the past year
- Literate in English/Spanish
- Willing to make a NRT-aided quit attempt within the next week
Who cannot join
- Pregnancy (according to urine pregnancy test)
- Breastfeeding or planning to become pregnant (self-report)
- Recent (past 3 months) cardiovascular trauma: myocardial infarction, stroke (self-report)
- Current use (past 30 days) of alternative tobacco products (e.g., electronic cigarettes, smokeless tobacco) or smoking cessation medications (self-report)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accelerating Health Equity Via Just-In-Time Adaptive Interventions (JITAIs): Scalable and High Impact mHealth Precision Smoking Relapse Prevention.
The goal of this clinical trial is to test a GPS (Global Positioning System)-enabled smartphone app (QuitBuddy) in current smokers. The main questions it aims to answer are:
- Is Quitbuddy a good treatment for quitting smoking and "staying quit"?
- Will a second treatment that connects people to help for their social and financial needs improve Quitbuddy?
Participants will:
- get nicotine lozenges in the mail
- check in with the study team to report on their quitting progress after 1 day, 1 week, 1 month, 2 months, 3 months, and 6 months
Researchers will compare Quitbuddy to an app made by the National Cancer Institute to see if Quitbuddy is better for helping people stay quit.
Read the detailed description
Tobacco smoking is a primary preventable trans-diagnostic risk factor that if targeted more effectively, could reduce a wide range of health disparities in prevalence, severity, treatment efficacy, and mortality across many chronic health conditions (e.g., diabetes, obstructive sleep apnea), reduce treatment complexity/multi-morbidity, and reduce healthcare costs up to 80%. The Southeast, in particular, has an urgent need to disrupt the status quo of tobacco control (<2% The Centers for Disease Control and Prevention (CDC) recommended tobacco control appropriations; highest smoking and mortality) driven in large part through neglected patterns of social determinants of health (SDoH; poverty, access to care) that disproportionately impact racial and ethnic minorities in the form of greater smoking and chronic disease rates, and ultimately nearly a decade of life lost. Unfortunately, only 5% of smoking cessation attempts last at least one year, with lower success among Black smokers even though they smoke at similar rates and intensity, and make more quit attempts. Accordingly, mobile health (mHealth) may have particular utility in addressing racial disparities.
Black smokers show high engagement rates with smartphones to access healthcare and greater adherence to digital interventions, which may facilitate tailoring to meet distinct needs. There is an urgent need to overcome equity gaps, which will require diversity and inclusion of individuals from underrepresented races/ethnicities to identify effective treatments. There is a need for just-in-time adaptive interventions (JITAIs) that 1) can be deployed rapidly (ideally before craving occurs), 2) effectively prevent or attenuate cravings quickly, and 3) are amenable to personalized treatment. Quitbuddy, the automated, yet personalized, JITAI app developed by the investigators, allows patients to prepare for high-risk situations before they arise, effectively promoting abstinence and preventing relapse. The overall goals are to optimize smart algorithms, identify personalized relapse risk, and automatically prompt NRT delivery in a real-time, preemptive manner, upon approaching personalized high-risk locations. Results from a National Institute on Drug abuse (NIDA)-funded (K23) pilot randomized controlled trial demonstrated outstanding usability (top 10% of over 500 apps), acceptability (>80% compliance), and technical feasibility (<10% GPS data loss). The investigators will build upon these promising data by testing effectiveness in a fully powered and rigorous SMART design with diverse representation of underserved populations and meeting community needs for SDoH interventions.
Specific Aims
Aims 1 \& 2: Evaluate QuitBuddy and SDoH augmentation intervention effectiveness for smoking cessation and relapse prevention via pragmatic remote SMART design (N=2,090).
Expected Outcome: Superior 6-month biochemically verified abstinence rates for the QuitBuddy and SDoH augmentation interventions, relative to controls.
Exploratory Aims: Test potential moderators/mediators of the effectiveness of the interventions.
This approach integrates for the first time established theories of relapse risk, evidence-based treatment, smartphone/GPS technology, and SDoH. This project offers high-impact solutions to address health disparities across a wide range of chronic diseases that disproportionately affect under-served populations.
- Conditions
- Tobacco Use Disorder, Tobacco Dependence
- Being tested
- Quitbuddy, Control, SDoH Augmentation, SDoH Control
- Keywords
- Smoking Cessation, Nicotine Replacement Therapy, Ecological Momentary Assessment, GPS, mHealth, Digital Intervention, Social Determinants of Health
- Medical subject headings
- Tobacco Use Disorder, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuitbuddyOther
Participants will be mailed a one week supply of nicotine lozenges as nicotine replacement therapy (NRT) for their upcoming quit attempt, with the ability to order more as needed. Participants will have a set "Target Quit Date" (TQD) set on Day 8 after enrollment, following one week of ad-lib smoking that comprises the pre-TQD EMA/GPS smoking data collection. GPS guided NRT usage prompts, via hotspot algorithms, will be provided to participants in the Quitbuddy Arm. Participants will contribute four weeks of post-TQD EMA/GPS data to capture lapses and NRT use in real-time. Carbon Monoxide (CO) levels will be tested at each of the six post-TQD remote assessments to provide objective verification of smoking status (i.e., 1 day, 1 week, 1 month, 2 month, 3 month, and 6 month abstinence rates). Computerized data collection methods (RedCap) will be used throughout the study to optimize quality assurance.
ControlOther
Participants will be mailed a one week supply of nicotine lozenges as nicotine replacement therapy (NRT) for their upcoming quit attempt, with the ability to order more as needed. Participants will have a set "Target Quit Date" (TQD) set on Day 8 after enrollment, following one week of ad-lib smoking that comprises the pre-TQD smoking data collection. Participants will contribute four weeks of post-TQD data to capture lapses and NRT use. CO levels will be tested at each of the six post-TQD remote assessments to provide objective verification of smoking status (i.e., 1 day, 1 week, 1 month, 2 month, 3 month, and 6 month abstinence rates). Computerized data collection methods (RedCap) will be used throughout the study to optimize quality assurance.
SDoH AugmentationOther
The SDoH intervention is based on the findhelp.org online platform, with customization to meet the specific needs of the study and communities being served: includes validated SDoH assessments, personalized social needs searching based on priorities, access to the most comprehensive social service database, and a streamlined closed loop referral system that integrates with workflows.
SDoH ControlOther
No SDoH intervention
| Study group | Role | What they receive |
|---|---|---|
| Quitbuddy | Experimental | Participants will be assigned to use a smartphone app (QuitBuddy) that will automatically guide NRT treatment delivery through the integration of ecological momentary assessments (EMA) and GPS into personalized relapse prevention algorithms. Receives: Other: Quitbuddy; Other: SDoH Augmentation; Other: SDoH Control |
| Control | Active comparator | Control is intended to approximate the real-world experience where Participants will use The National Cancer Institute's smartphone app (QuitGuide) and will self-manage NRT treatment delivery based on written instructions. Receives: Other: Control; Other: SDoH Augmentation; Other: SDoH Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abstinence Rate
Self-report. Participant enters number of cigarettes smoked.
Measured: 24 hours
NRT Compliance
Self report. Participant enters number of nicotine lozenges used.
Measured: 24 hours
Cravings
Self reported number of cravings experienced.
Measured: 24 hours
Withdrawal 1-day
Minnesota Nicotine Withdrawal Scale - A nine-item self-report scale for examining the severity of nicotine withdrawal symptoms in a subject. Participants select 0 (none) - 4 (severe) for each of the items. Higher scores correspond to higher perceived severity of withdrawal.
Measured: Measured one day after a participant's target quit-date.
Withdrawal 1-week
Minnesota Nicotine Withdrawal Scale - A nine-item self-report scale for examining the severity of nicotine withdrawal symptoms in a subject. Participants select 0 (none) - 4 (severe) for each of the items. Higher scores correspond to higher perceived severity of withdrawal.
Measured: Measured one week after a participant's target quit-date.
Withdrawal 1-month
Minnesota Nicotine Withdrawal Scale - A nine-item self-report scale for examining the severity of nicotine withdrawal symptoms in a subject. Participants select 0 (none) - 4 (severe) for each of the items. Higher scores correspond to higher perceived severity of withdrawal.
Measured: Measured one month after a participant's target quit-date.
Withdrawal 2-month
Minnesota Nicotine Withdrawal Scale - A nine-item self-report scale for examining the severity of nicotine withdrawal symptoms in a subject. Participants select 0 (none) - 4 (severe) for each of the items. Higher scores correspond to higher perceived severity of withdrawal.
Measured: Measured two months after a participant's target quit-date.
Withdrawal 3-month
Minnesota Nicotine Withdrawal Scale - A nine-item self-report scale for examining the severity of nicotine withdrawal symptoms in a subject. Participants select 0 (none) - 4 (severe) for each of the items. Higher scores correspond to higher perceived severity of withdrawal.
Measured: Measured three months after a participant's target quit-date.
Withdrawal 6-month
Minnesota Nicotine Withdrawal Scale - A nine-item self-report scale for examining the severity of nicotine withdrawal symptoms in a subject. Participants select 0 (none) - 4 (severe) for each of the items. Higher scores correspond to higher perceived severity of withdrawal.
Measured: Measured six months after a participant's target quit-date.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2022
- Study start2 Oct 2023 (estimated)
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Why it stopped: Change in Principal Investigator Affilation/Role
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Sequential
- Model description
- Will employ two interventions as part of a sequential multiple-assignment randomized trial (SMART). First-stage intervention - Participants are randomized to one of two arms, QuitBuddy (a novel smoking cessation app) or Control. Participants will be randomized again after reaching a predefined tailoring variable, operationalized as biochemically verified 24h smoking abstinence within 1-week from target quit date (TQD). Second-stage intervention - Social determinants of health (SDoH) intervention. Participants are randomized to receive either a digital SDoH intervention (powered by findhelp.org and integrated into QuitBuddy) or will receive an emailed list of social service providers in their Zip Code (standard care control).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bryan W. Heckman
- Sponsor type
- University, hospital or other
- Collaborators
- City of Hope Medical Center, Virginia Tech Carilion School of Medicine and Research Institute
- Responsible party
- Sponsor-investigator, Bryan W. Heckman, Meharry Medical College
- Investigators
- Bryan W Heckman, Ph.D., Principal investigator, Meharry Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05625685
- Sponsor's protocol ID
- 1P50MD017347-01
- Status last verified
- May 2024
- First submitted
- 1 Nov 2022
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerating Health Equity Via Just-In-Time Adaptive Interventions (JITAIs): Scalable and High Impact mHealth Precision Smoking Relapse Prevention.
- ClinicalTrials.gov ID
- NCT05625685
- Acronym / sponsor ID
- 1P50MD017347-01
- Conditions
- Tobacco Use Disorder, Tobacco Dependence
- Keywords
- Smoking Cessation, Nicotine Replacement Therapy, Ecological Momentary Assessment, GPS, mHealth, Digital Intervention, Social Determinants of Health
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Change in Principal Investigator Affilation/Role
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bryan W. HeckmanUniversity, hospital or other
- Collaborators
- City of Hope Medical Center, Virginia Tech Carilion School of Medicine and Research Institute
- Study start
- 2 Oct 2023 (estimated)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 23 Nov 2022 (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.
The goal of this clinical trial is to test a GPS (Global Positioning System)-enabled smartphone app (QuitBuddy) in current smokers. The main questions it aims to answer are:
- Is Quitbuddy a good treatment for quitting smoking and "staying quit"?
- Will a second treatment that connects people to help for their social and financial needs improve Quitbuddy?
Participants will:
- get nicotine lozenges in the mail
- check in with the study team to report on their quitting progress after 1 day, 1 week, 1 month, 2 months, 3 months, and 6 months
Researchers will compare Quitbuddy to an app made by the National Cancer Institute to see if Quitbuddy is better for helping people stay quit.
Detailed description
Tobacco smoking is a primary preventable trans-diagnostic risk factor that if targeted more effectively, could reduce a wide range of health disparities in prevalence, severity, treatment efficacy, and mortality across many chronic health conditions (e.g., diabetes, obstructive sleep apnea), reduce treatment complexity/multi-morbidity, and reduce healthcare costs up to 80%. The Southeast, in particular, has an urgent need to disrupt the status quo of tobacco control (<2% The Centers for Disease Control and Prevention (CDC) recommended tobacco control appropriations; highest smoking and mortality) driven in large part through neglected patterns of social determinants of health (SDoH; poverty, access to care) that disproportionately impact racial and ethnic minorities in the form of greater smoking and chronic disease rates, and ultimately nearly a decade of life lost. Unfortunately, only 5% of smoking cessation attempts last at least one year, with lower success among Black smokers even though they smoke at similar rates and intensity, and make more quit attempts. Accordingly, mobile health (mHealth) may have particular utility in addressing racial disparities.
Black smokers show high engagement rates with smartphones to access healthcare and greater adherence to digital interventions, which may facilitate tailoring to meet distinct needs. There is an urgent need to overcome equity gaps, which will require diversity and inclusion of individuals from underrepresented races/ethnicities to identify effective treatments. There is a need for just-in-time adaptive interventions (JITAIs) that 1) can be deployed rapidly (ideally before craving occurs), 2) effectively prevent or attenuate cravings quickly, and 3) are amenable to personalized treatment. Quitbuddy, the automated, yet personalized, JITAI app developed by the investigators, allows patients to prepare for high-risk situations before they arise, effectively promoting abstinence and preventing relapse. The overall goals are to optimize smart algorithms, identify personalized relapse risk, and automatically prompt NRT delivery in a real-time, preemptive manner, upon approaching personalized high-risk locations. Results from a National Institute on Drug abuse (NIDA)-funded (K23) pilot randomized controlled trial demonstrated outstanding usability (top 10% of over 500 apps), acceptability (>80% compliance), and technical feasibility (<10% GPS data loss). The investigators will build upon these promising data by testing effectiveness in a fully powered and rigorous SMART design with diverse representation of underserved populations and meeting community needs for SDoH interventions.
Specific Aims
Aims 1 \& 2: Evaluate QuitBuddy and SDoH augmentation intervention effectiveness for smoking cessation and relapse prevention via pragmatic remote SMART design (N=2,090).
Expected Outcome: Superior 6-month biochemically verified abstinence rates for the QuitBuddy and SDoH augmentation interventions, relative to controls.
Exploratory Aims: Test potential moderators/mediators of the effectiveness of the interventions.
This approach integrates for the first time established theories of relapse risk, evidence-based treatment, smartphone/GPS technology, and SDoH. This project offers high-impact solutions to address health disparities across a wide range of chronic diseases that disproportionately affect under-served populations.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Will employ two interventions as part of a sequential multiple-assignment randomized trial (SMART). First-stage intervention - Participants are randomized to one of two arms, QuitBuddy (a novel smoking cessation app) or Control. Participants will be randomized again after reaching a predefined tailoring variable, operationalized as biochemically verified 24h smoking abstinence within 1-week from target quit date (TQD). Second-stage intervention - Social determinants of health (SDoH) intervention. Participants are randomized to receive either a digital SDoH intervention (powered by findhelp.org and integrated into QuitBuddy) or will receive an emailed list of social service providers in their Zip Code (standard care control).
| Arm | Type | Receives |
|---|---|---|
| Quitbuddy | Experimental | Other: Quitbuddy, Other: SDoH Augmentation, Other: SDoH ControlParticipants will be assigned to use a smartphone app (QuitBuddy) that will automatically guide NRT treatment delivery through the integration of ecological momentary assessments (EMA) and GPS into personalized relapse prevention algorithms. |
| Control | Active comparator | Other: Control, Other: SDoH Augmentation, Other: SDoH ControlControl is intended to approximate the real-world experience where Participants will use The National Cancer Institute's smartphone app (QuitGuide) and will self-manage NRT treatment delivery based on written instructions. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 21 years of age
- Smoking at least 10 cigarettes per day for the past year
- Literate in English/Spanish
- Willing to make a NRT-aided quit attempt within the next week
Key exclusion criteria (4 listed)
- Pregnancy (according to urine pregnancy test)
- Breastfeeding or planning to become pregnant (self-report)
- Recent (past 3 months) cardiovascular trauma: myocardial infarction, stroke (self-report)
- Current use (past 30 days) of alternative tobacco products (e.g., electronic cigarettes, smokeless tobacco) or smoking cessation medications (self-report)
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 |
|---|---|---|
| QuitbuddyParticipants will be mailed a one week supply of nicotine lozenges as nicotine replacement therapy (NRT) for their upcoming quit attempt, with the ability to order more as needed. Participants will have a set "Target Quit Date" (TQD) set on Day 8 after enrollment, following one week of ad-lib smoking that comprises the pre-TQD EMA/GPS smoking data collection. GPS guided NRT usage prompts, via hotspot algorithms, will be provided to participants in the Quitbuddy Arm. Participants will contribute four weeks of post-TQD EMA/GPS data to capture lapses and NRT use in real-time. Carbon Monoxide (CO) levels will be tested at each of the six post-TQD remote assessments to provide objective verification of smoking status (i.e., 1 day, 1 week, 1 month, 2 month, 3 month, and 6 month abstinence rates). Computerized data collection methods (RedCap) will be used throughout the study to optimize quality assurance. | Other | Quitbuddy |
| ControlParticipants will be mailed a one week supply of nicotine lozenges as nicotine replacement therapy (NRT) for their upcoming quit attempt, with the ability to order more as needed. Participants will have a set "Target Quit Date" (TQD) set on Day 8 after enrollment, following one week of ad-lib smoking that comprises the pre-TQD smoking data collection. Participants will contribute four weeks of post-TQD data to capture lapses and NRT use. CO levels will be tested at each of the six post-TQD remote assessments to provide objective verification of smoking status (i.e., 1 day, 1 week, 1 month, 2 month, 3 month, and 6 month abstinence rates). Computerized data collection methods (RedCap) will be used throughout the study to optimize quality assurance. | Other | Control |
| SDoH AugmentationThe SDoH intervention is based on the findhelp.org online platform, with customization to meet the specific needs of the study and communities being served: includes validated SDoH assessments, personalized social needs searching based on priorities, access to the most comprehensive social service database, and a streamlined closed loop referral system that integrates with workflows. | Other | Control, Quitbuddy |
| SDoH ControlNo SDoH intervention | Other | Control, Quitbuddy |
Primary outcome
Abstinence Rate
Time frame: 24 hours
Self-report. Participant enters number of cigarettes smoked.
NRT Compliance
Time frame: 24 hours
Self report. Participant enters number of nicotine lozenges used.
Cravings
Time frame: 24 hours
Self reported number of cravings experienced.
Withdrawal 1-day
Time frame: Measured one day after a participant's target quit-date.
Minnesota Nicotine Withdrawal Scale - A nine-item self-report scale for examining the severity of nicotine withdrawal symptoms in a subject. Participants select 0 (none) - 4 (severe) for each of the items. Higher scores correspond to higher perceived severity of withdrawal.
Withdrawal 1-week
Time frame: Measured one week after a participant's target quit-date.
Minnesota Nicotine Withdrawal Scale - A nine-item self-report scale for examining the severity of nicotine withdrawal symptoms in a subject. Participants select 0 (none) - 4 (severe) for each of the items. Higher scores correspond to higher perceived severity of withdrawal.
Withdrawal 1-month
Time frame: Measured one month after a participant's target quit-date.
Minnesota Nicotine Withdrawal Scale - A nine-item self-report scale for examining the severity of nicotine withdrawal symptoms in a subject. Participants select 0 (none) - 4 (severe) for each of the items. Higher scores correspond to higher perceived severity of withdrawal.
Withdrawal 2-month
Time frame: Measured two months after a participant's target quit-date.
Minnesota Nicotine Withdrawal Scale - A nine-item self-report scale for examining the severity of nicotine withdrawal symptoms in a subject. Participants select 0 (none) - 4 (severe) for each of the items. Higher scores correspond to higher perceived severity of withdrawal.
Withdrawal 3-month
Time frame: Measured three months after a participant's target quit-date.
Minnesota Nicotine Withdrawal Scale - A nine-item self-report scale for examining the severity of nicotine withdrawal symptoms in a subject. Participants select 0 (none) - 4 (severe) for each of the items. Higher scores correspond to higher perceived severity of withdrawal.
Withdrawal 6-month
Time frame: Measured six months after a participant's target quit-date.
Minnesota Nicotine Withdrawal Scale - A nine-item self-report scale for examining the severity of nicotine withdrawal symptoms in a subject. Participants select 0 (none) - 4 (severe) for each of the items. Higher scores correspond to higher perceived severity of withdrawal.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- 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.
Bryan W Heckman, Ph.D. principal investigator
Meharry Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quitbuddy and SDoH Augmentation in people with Tobacco Use Disorder and Tobacco Dependence, run by Bryan W. Heckman at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 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: withdrawn, as of the sponsor's last update on 8 May 2024. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Abstinence Rate (time frame: 24 hours). The study lists 9 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 8 May 2024.