Smoking CessationNCT03690596
Smoking Relapse Prevention Via Just-in-Time-Adaptive Interventions
A study testing NRT + QuitBuddy, NRT + QuitBuddy-Recall and Treatment as Usual in people with Smoking Cessation, run by Meharry Medical College at 1 site in United States.
Trial summary
A small-scale randomized controlled trial (RCT) will pilot test a personalized JITAI designed to guide delivery of fast acting nicotine replacement therapy (NRT; lozenge) in real-time, to prevent smoking relapse. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- NRT + QuitBuddy, NRT + QuitBuddy-Recall and Treatment as Usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2019to 31 Jan 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
- at least 18 years of age
- daily cigarette smoker of > 9 cigarettes/day for past year
- CO breath monitor detects > 10ppm
- literate in English
- willing to make a quit attempt in the next week with nicotine replacement therapy
- no plans to travel outside of a 100-mile radius of Charleston during the study
Who cannot join
- FDA contraindications for use of NRT:
- Pregnant
- Breastfeeding or planning to become pregnant
- Recent (past 3 months) cardiovascular trauma: MI, stroke
- current use (past 30 days) of alternative tobacco products or smoking cessation medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Personalized Smoking Relapse Prevention Delivered in Real-Time Via Just-in-Time-Adaptive Interventions
A small-scale randomized controlled trial (RCT) will pilot test a personalized JITAI designed to guide delivery of fast acting nicotine replacement therapy (NRT; lozenge) in real-time, to prevent smoking relapse. Specifically, a smartphone application (app), will integrate pre-quit smoking data with objective location data captured via global positioning system (GPS) to establish relapse risk (hotspot) algorithms. During a quit attempt, the GPS-enabled app (QuitBuddy) will detect proximity to hotspots and deliver NRT prompts, all of which will occur automatically and prior to exposure. Thus, QuitBuddy will optimize NRT use to prevent cue-provoked cravings known to undermine sustained abstinence, thereby repurposing this evidence-based cessation medication to promote relapse prevention. QuitBuddy will be tested against standard care (NRT with brief instructions). Two versions of QuitBuddy will be tested, which will differ only in how hotspot algorithms are derived: retrospectively from locations recalled at the onset of a quit attempt (QuitBuddy-Recall) or based on real-time EMA completed pre-quit (QuitBuddy).
- Conditions
- Smoking Cessation
- Being tested
- NRT + QuitBuddy, NRT + QuitBuddy-Recall, Treatment as Usual
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NRT + QuitBuddyOther
QuitBuddy treatment app and 1 month supply of 4 mg nicotine lozenge
NRT + QuitBuddy-RecallOther
QuitBuddy-Recall treatment app and 1 month supply of 4 mg nicotine lozenge
Treatment as UsualOther
1 month supply of 4 mg nicotine lozenge
| Study group | Role | What they receive |
|---|---|---|
| NRT + QuitBuddy | Experimental | This smartphone app will identify high-risk situations through real-time EMA data collected before and during a quit attempt. One week of pre-quit smoking behaviors will be integrated with passively sensed GPS data to create hotspot maps. Hotspot maps will provide interactive visualizations of relapse risk. GPS triggered NRT/behavioral prompts will occur when participants come within 50m from the centroid of a hotspot. Receives: Other: NRT + QuitBuddy |
| NRT + QuitBuddy-Recall | Experimental | This smartphone app will identify high-risk situations through retrospective recall of locations where the patient typically smoked. Hotspot maps will provide interactive visualizations of relapse risk. GPS triggered NRT/behavioral prompts will occur when participants come within 50m from the centroid of a hotspot. Receives: Other: NRT + QuitBuddy-Recall |
| NRT Control (treatment as usual) | Active comparator | Standard Care Control is intended to approximate the real-world experience where smokers obtain over-the-counter NRT and, after brief instructions at the outset (~1 lozenge per hour, during cravings, and <20 per day), determine usage for themselves. Receives: Other: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abstinence from cigarettes
Biochemically-verified smoking status (CO<6) obtained at 3-month follow-up
Measured: 12 Weeks
Secondary outcomes (2)
Abstinence from cigarettes
Biochemically-verified smoking status (CO<6) obtained at 1-month follow-up
Measured: 4 weeks
Abstinence from cigarettes
Biochemically-verified smoking status (CO<6) obtained at 1-week follow-up
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2018
- Study start16 Apr 2019
- Primary completion31 Jan 2022 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meharry Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Medical University of South Carolina
- Responsible party
- Sponsor
- Investigators
- Bryan W Heckman, PhD, Principal investigator, Meharry Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03690596
- Sponsor's protocol ID
- 00061239
- Other IDs
- K23DA041616
- Status last verified
- Dec 2021
- First submitted
- 24 Sep 2018
- Last updated
- 13 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Smoking Relapse Prevention Delivered in Real-Time Via Just-in-Time-Adaptive Interventions
- ClinicalTrials.gov ID
- NCT03690596
- Acronym / sponsor ID
- 00061239
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Meharry Medical CollegeUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), Medical University of South Carolina
- Study start
- 16 Apr 2019 (actual)
- Primary completion
- 31 Jan 2022 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 1 Oct 2018 (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.
A small-scale randomized controlled trial (RCT) will pilot test a personalized JITAI designed to guide delivery of fast acting nicotine replacement therapy (NRT; lozenge) in real-time, to prevent smoking relapse. Specifically, a smartphone application (app), will integrate pre-quit smoking data with objective location data captured via global positioning system (GPS) to establish relapse risk (hotspot) algorithms. During a quit attempt, the GPS-enabled app (QuitBuddy) will detect proximity to hotspots and deliver NRT prompts, all of which will occur automatically and prior to exposure. Thus, QuitBuddy will optimize NRT use to prevent cue-provoked cravings known to undermine sustained abstinence, thereby repurposing this evidence-based cessation medication to promote relapse prevention. QuitBuddy will be tested against standard care (NRT with brief instructions). Two versions of QuitBuddy will be tested, which will differ only in how hotspot algorithms are derived: retrospectively from locations recalled at the onset of a quit attempt (QuitBuddy-Recall) or based on real-time EMA completed pre-quit (QuitBuddy).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NRT + QuitBuddy | Experimental | Other: NRT + QuitBuddyThis smartphone app will identify high-risk situations through real-time EMA data collected before and during a quit attempt. One week of pre-quit smoking behaviors will be integrated with passively sensed GPS data to create hotspot maps. Hotspot maps will provide interactive visualizations of relapse risk. GPS triggered NRT/behavioral prompts will occur when participants come within 50m from the centroid of a hotspot. |
| NRT + QuitBuddy-Recall | Experimental | Other: NRT + QuitBuddy-RecallThis smartphone app will identify high-risk situations through retrospective recall of locations where the patient typically smoked. Hotspot maps will provide interactive visualizations of relapse risk. GPS triggered NRT/behavioral prompts will occur when participants come within 50m from the centroid of a hotspot. |
| NRT Control (treatment as usual) | Active comparator | Other: Treatment as UsualStandard Care Control is intended to approximate the real-world experience where smokers obtain over-the-counter NRT and, after brief instructions at the outset (~1 lozenge per hour, during cravings, and <20 per day), determine usage for themselves. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- at least 18 years of age
- daily cigarette smoker of > 9 cigarettes/day for past year
- CO breath monitor detects > 10ppm
- literate in English
- willing to make a quit attempt in the next week with nicotine replacement therapy
Key exclusion criteria (5 listed)
- FDA contraindications for use of NRT:
- current use (past 30 days) of alternative tobacco products or smoking cessation medications
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 |
|---|---|---|
| NRT + QuitBuddyQuitBuddy treatment app and 1 month supply of 4 mg nicotine lozenge | Other | NRT + QuitBuddy |
| NRT + QuitBuddy-RecallQuitBuddy-Recall treatment app and 1 month supply of 4 mg nicotine lozenge | Other | NRT + QuitBuddy-Recall |
| Treatment as Usual1 month supply of 4 mg nicotine lozenge | Other | NRT Control (treatment as usual) |
Primary outcome
Abstinence from cigarettes
Time frame: 12 Weeks
Biochemically-verified smoking status (CO<6) obtained at 3-month follow-up
2 secondary outcomes
Abstinence from cigarettes
Time frame: 4 weeks
Abstinence from cigarettes
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2021.
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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, PhD 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 NRT + QuitBuddy, NRT + QuitBuddy-Recall and Treatment as Usual in people with Smoking Cessation, run by Meharry Medical College 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 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: status not confirmed, as of the sponsor's last update on 13 Dec 2021. 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?
Results are not available in the source record.
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 from cigarettes (time frame: 12 Weeks). 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 Dec 2021.