Tobacco Use CessationNCT04172623
Evaluating the Feasibility and Efficacy of a Real-time Smoking Intervention Using Wearable Technology
A study testing Real-Time Smoking Intervention and Standard Treatment in people with Tobacco Use Cessation, run by Yale University at 1 site in United States.
Trial summary
This study will use wearable technology to test the feasibility and efficacy of delivering a novel real-time smoking intervention to improve standard tobacco treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Use Cessation
- What is being tested?
- Real-Time Smoking Intervention and Standard Treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2019to 31 Jan 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 or older
- Able to read English
- Cigarette smoker
- Seeking smoking cessation treatment
Who cannot join
- Serious psychiatric or medical condition
- Unable or unwilling to complete study protocol
Trial locations and contacts
1 site in 1 country.
About this study
This study will use wearable technology to test the feasibility and efficacy of delivering a novel real-time smoking intervention to improve standard tobacco treatment.
Read the detailed description
The goals of this project include evaluating the feasibility, acceptability, and helpfulness of the real-time smoking intervention and to assess the preliminary efficacy of the real-time intervention as an adjunct to standard tobacco treatment. Rates of adherence, participant satisfaction, and perceived usefulness will be evaluated through post-treatment interviews and ratings. Biochemically confirmed 7-day point prevalence abstinence will be compared between the experimental and control groups at the end of treatment (week 8).
- Conditions
- Tobacco Use Cessation
- Being tested
- Real-Time Smoking Intervention, Standard Treatment
- Medical subject headings
- Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-Time Smoking InterventionBehavioural
Adult smokers will use wearable technology in order to receive real-time feedback as a smoking intervention in addition to standard treatment.
Standard TreatmentBehavioural
Adult smokers will receive standard outpatient tobacco treatment.
| Study group | Role | What they receive |
|---|---|---|
| Real-Time Smoking Intervention | Experimental | Adult smokers will use wearable technology in order to receive real-time feedback as a smoking intervention in addition to standard treatment. Receives: Behavioral: Real-Time Smoking Intervention; Behavioral: Standard Treatment |
| Standard Treatment | Active comparator | Adult smokers will receive standard outpatient tobacco treatment. Receives: Behavioral: Standard Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cigarettes
Self-reported cigarette use (Timeline follow-back data) during the 8-week study to estimate effect sizes between groups.
Measured: Baseline and Week 8
Secondary outcomes (1)
% Days Abstinent From Cigarettes
Timeline follow-back data will be collected to determine the % of days abstinent from cigarettes.
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start1 Jun 2019
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
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 Tobacco Use CessationStudies of the same condition, open and under way.
- More trials run by Yale 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel group randomized trial design comparing smoking outcomes when receiving standard treatment vs. standard treatment plus real-time smoking intervention.
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Patterson Trust Mentored Research Award: Clinical, Health Services and Policy Research
- Responsible party
- Sponsor
- Investigators
- Krysten Bold, Ph.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04172623
- Sponsor's protocol ID
- 2000024740
- Status last verified
- Feb 2023
- First submitted
- 8 Jul 2019
- Last updated
- 13 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- 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 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Feasibility and Efficacy of a Real-time Smoking Intervention Using Wearable Technology
- ClinicalTrials.gov ID
- NCT04172623
- Acronym / sponsor ID
- 2000024740
- Conditions
- Tobacco Use Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Patterson Trust Mentored Research Award: Clinical, Health Services and Policy Research
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 21 Nov 2019 (actual)
- Results
- Posted 26 Jan 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will use wearable technology to test the feasibility and efficacy of delivering a novel real-time smoking intervention to improve standard tobacco treatment.
Detailed description
The goals of this project include evaluating the feasibility, acceptability, and helpfulness of the real-time smoking intervention and to assess the preliminary efficacy of the real-time intervention as an adjunct to standard tobacco treatment. Rates of adherence, participant satisfaction, and perceived usefulness will be evaluated through post-treatment interviews and ratings. Biochemically confirmed 7-day point prevalence abstinence will be compared between the experimental and control groups at the end of treatment (week 8).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel group randomized trial design comparing smoking outcomes when receiving standard treatment vs. standard treatment plus real-time smoking intervention.
| Arm | Type | Receives |
|---|---|---|
| Real-Time Smoking Intervention | Experimental | Behavioral: Real-Time Smoking Intervention, Behavioral: Standard TreatmentAdult smokers will use wearable technology in order to receive real-time feedback as a smoking intervention in addition to standard treatment. |
| Standard Treatment | Active comparator | Behavioral: Standard TreatmentAdult smokers will receive standard outpatient tobacco treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 or older
- Able to read English
- Cigarette smoker
- Seeking smoking cessation treatment
Key exclusion criteria (2 listed)
- Serious psychiatric or medical condition
- Unable or unwilling to complete study protocol
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 |
|---|---|---|
| Real-Time Smoking InterventionAdult smokers will use wearable technology in order to receive real-time feedback as a smoking intervention in addition to standard treatment. | Behavioural | Real-Time Smoking Intervention |
| Standard TreatmentAdult smokers will receive standard outpatient tobacco treatment. | Behavioural | Real-Time Smoking Intervention, Standard Treatment |
Primary outcome
Change in Cigarettes
Time frame: Baseline and Week 8
Self-reported cigarette use (Timeline follow-back data) during the 8-week study to estimate effect sizes between groups.
1 secondary outcome
% Days Abstinent From Cigarettes
Time frame: Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 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.
Krysten Bold, Ph.D. principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real-Time Smoking Intervention and Standard Treatment in people with Tobacco Use Cessation, run by Yale University 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 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 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 26 Jan 2023). 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?
Change in Cigarettes (time frame: Baseline and Week 8). 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 13 Feb 2023.