Smoking CessationNCT05224154
Re-Connect Application for Smoking Cessation
A study testing Abstinent Contingent (AC) Re-Connect in people with Smoking Cessation and Acceptability of Health Care, run by Rowan University at 1 site in United States.
Trial summary
This series of studies will explore the acceptability, feasibility, and preliminary efficacy of making access to smartphone applications contingent on objective evidence of smoking abstinence. 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, Acceptability of Health Care, Nicotine Dependence, Cigarettes
- What is being tested?
- Abstinent Contingent (AC) Re-Connect
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Dec 2021to 28 Feb 2026
- 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
- individuals who report smoking at least 10 cigarettes per day for at least 2 years, -18 years of age or older
- do not have any health complications that might interfere with the study or require more intensive treatment (e.g., emphysema, chronic obstructive pulmonary disorder, asthma, lactose intolerance)
- report a strong desire to quit smoking (8 or higher on a 10-point Likert scale)
- has prior experience using a smartphone, speak English, and are literate, will be eligible for the study.
Who cannot join
- Individuals with mental health complications that are either un-managed or that have been managed for less than 6-months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Re-Connect Usability, Feasibility, Acceptability, and Preliminary Efficacy Testing
This series of studies will explore the acceptability, feasibility, and preliminary efficacy of making access to smartphone applications contingent on objective evidence of smoking abstinence.
Read the detailed description
Aim 1 will use small focus groups and feedback sessions (n = 4-6) to gain insight into the acceptability and usability of Re-Connect. Up to 3 single-case design studies (n = 4/round) will then be conducted to get more extended use of the app in a real world context to get additional information about usability and acceptability of the app. Aim 2 will involve a 2-group (AC vs SC), pilot randomized control trial to test the feasibility, acceptability, and preliminary efficacy of Re-Connect.
- Being tested
- Abstinent Contingent (AC) Re-Connect
- Medical subject headings
- Smoking Cessation, Patient Acceptance of Health Care, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abstinent Contingent (AC) Re-ConnectBehavioural
Participants in this group will be able to unblock highly desired, but non-essential (e.g., social networking, shopping, games) applications contingent on meeting goals for smoking abstinence, as verified by meeting carbon monoxide goals (CO<=6ppm).
| Study group | Role | What they receive |
|---|---|---|
| Abstinent Contingent (AC) Re-Connect | Experimental | Participants in this group will be able to unblock highly desired, but non-essential (e.g., social networking, shopping, games) applications contingent on meeting goals for smoking abstinence, as verified by meeting carbon monoxide goals (CO<=6ppm). Receives: Behavioral: Abstinent Contingent (AC) Re-Connect |
What is being measured
The primary outcome is the main question the study is designed to answer.
System Usability Survey
A survey that participants in Aim 1 usability testing will complete after testing out the Re-Connect application. Focus and feedback group participants, as well as single-case design participants, will complete this survey and a score of 75 or higher will be required before moving to the RCT in Aim 2.
Measured: through study completion, up to 12-weeks
Reconnect use (RCT, Aim 2)
Over the 6-month observation period we will track the how much and to what extent participants use Re-Connect and continue to submit CO samples.
Measured: 6-months
Duration of Re-Connect Use (RCT, Aim 2)
Over the 6-month study we will track how long participants are engaged with using Re-Connect.
Measured: 6-months
Acceptability (RCT, Aim 2)
At three time points we will have the participants complete a Treatment Acceptability Questionnaire to provide quantitative and qualitative feedback on their experience with using Re-Connect.
Measured: 6-months
Percent negative carbon monoxide samples
We will compare the percentage of CO samples that meet the abstinence goals during the 6-month study.
Measured: 6-months
7-day point prevalence of self-reported, and CO verified, smoking
Participants will provide self-reports and a CO sample to confirm smoking status throughout the 6-month study.
Measured: 6-months
Secondary outcomes (1)
Initial Acceptability
Individuals who respond to our advertisement for a smoking cessation intervention will be given information about Re-Connect and then they will be given the option of continuing to participate or discontinuing. Participants who discontinue will be asked why they are not interested to inform future versions of the intervention to make it more widely acceptable and therefore more likely to be adopted by a broader population.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start14 Dec 2021
- Primary completion28 Feb 2026
- Study completion28 Feb 2026
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Aim 1 will use small focus groups and feedback sessions (n = 4-6) to gain insight into the acceptability and usability of Re-Connect. Up to 3 single-case design studies (n = 4/round) will then be conducted to get more extended use of the app in a real world context to get additional information about usability and acceptability of the app. Aim 2 will involve a 2-group (AC vs SC), pilot randomized control trial to test the feasibility, acceptability, and preliminary efficacy of Re-Connect.
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rowan University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kentucky
- Responsible party
- Sponsor
- Investigators
- Bethany Raiff, PhD, Principal investigator, Rowan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05224154
- Sponsor's protocol ID
- PRO-2020-123
- Status last verified
- Jun 2026
- First submitted
- 12 Jan 2022
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified data will be shared if there is an appropriate need expressed by the investigator.
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Re-Connect Usability, Feasibility, Acceptability, and Preliminary Efficacy Testing
- ClinicalTrials.gov ID
- NCT05224154
- Acronym / sponsor ID
- PRO-2020-123
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Rowan UniversityUniversity, hospital or other
- Collaborators
- University of Kentucky
- Study start
- 14 Dec 2021 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 4 Feb 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.
This series of studies will explore the acceptability, feasibility, and preliminary efficacy of making access to smartphone applications contingent on objective evidence of smoking abstinence.
Detailed description
Aim 1 will use small focus groups and feedback sessions (n = 4-6) to gain insight into the acceptability and usability of Re-Connect. Up to 3 single-case design studies (n = 4/round) will then be conducted to get more extended use of the app in a real world context to get additional information about usability and acceptability of the app. Aim 2 will involve a 2-group (AC vs SC), pilot randomized control trial to test the feasibility, acceptability, and preliminary efficacy of Re-Connect.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Aim 1 will use small focus groups and feedback sessions (n = 4-6) to gain insight into the acceptability and usability of Re-Connect. Up to 3 single-case design studies (n = 4/round) will then be conducted to get more extended use of the app in a real world context to get additional information about usability and acceptability of the app. Aim 2 will involve a 2-group (AC vs SC), pilot randomized control trial to test the feasibility, acceptability, and preliminary efficacy of Re-Connect.
| Arm | Type | Receives |
|---|---|---|
| Abstinent Contingent (AC) Re-Connect | Experimental | Behavioral: Abstinent Contingent (AC) Re-ConnectParticipants in this group will be able to unblock highly desired, but non-essential (e.g., social networking, shopping, games) applications contingent on meeting goals for smoking abstinence, as verified by meeting carbon monoxide goals (CO<=6ppm). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- individuals who report smoking at least 10 cigarettes per day for at least 2 years, -18 years of age or older
- do not have any health complications that might interfere with the study or require more intensive treatment (e.g., emphysema, chronic obstructive pulmonary disorder, asthma, lactose intolerance)
- report a strong desire to quit smoking (8 or higher on a 10-point Likert scale)
- has prior experience using a smartphone, speak English, and are literate, will be eligible for the study.
Key exclusion criteria (1 listed)
- Individuals with mental health complications that are either un-managed or that have been managed for less than 6-months
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 |
|---|---|---|
| Abstinent Contingent (AC) Re-ConnectParticipants in this group will be able to unblock highly desired, but non-essential (e.g., social networking, shopping, games) applications contingent on meeting goals for smoking abstinence, as verified by meeting carbon monoxide goals (CO<=6ppm). | Behavioural | Abstinent Contingent (AC) Re-Connect |
Primary outcome
System Usability Survey
Time frame: through study completion, up to 12-weeks
A survey that participants in Aim 1 usability testing will complete after testing out the Re-Connect application. Focus and feedback group participants, as well as single-case design participants, will complete this survey and a score of 75 or higher will be required before moving to the RCT in Aim 2.
Reconnect use (RCT, Aim 2)
Time frame: 6-months
Over the 6-month observation period we will track the how much and to what extent participants use Re-Connect and continue to submit CO samples.
Duration of Re-Connect Use (RCT, Aim 2)
Time frame: 6-months
Over the 6-month study we will track how long participants are engaged with using Re-Connect.
Acceptability (RCT, Aim 2)
Time frame: 6-months
At three time points we will have the participants complete a Treatment Acceptability Questionnaire to provide quantitative and qualitative feedback on their experience with using Re-Connect.
Percent negative carbon monoxide samples
Time frame: 6-months
We will compare the percentage of CO samples that meet the abstinence goals during the 6-month study.
7-day point prevalence of self-reported, and CO verified, smoking
Time frame: 6-months
Participants will provide self-reports and a CO sample to confirm smoking status throughout the 6-month study.
1 secondary outcome
Initial Acceptability
Time frame: 1 day
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 2 Sep 2026.
- Individual participant dataSharing planned: Undecided. De-identified data will be shared if there is an appropriate need expressed by the investigator.
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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.
Bethany Raiff, PhD principal investigator
Rowan 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 Abstinent Contingent (AC) Re-Connect in people with Smoking Cessation and Acceptability of Health Care, run by Rowan 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 1 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 2 Sep 2026. 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 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?
System Usability Survey (time frame: through study completion, up to 12-weeks). The study lists 6 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 2 Sep 2026.