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NCT Number: NCT05224154

Re-Connect Application for Smoking Cessation

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.

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Key information

Conditions

Smoking Cessation Acceptability of Health Care Behavior Chemically-Induced Disorders Health Behavior Mental Disorders Nicotine Dependence, Cigarettes Patient Acceptance of Health Care Substance-Related Disorders Tobacco Use Disorder Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rowan University

Glassboro, New Jersey, 08028, United States

Location status: Recruiting

Location contact

Bethany Raiff, PhD

CONTACT

[email protected]

856-256-4500 ext. 5-3782

Bethany Raiff, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Individuals with mental health complications that are either un-managed or that have been managed for less than 6-months

Treatment and study plan

Abstinent Contingent (AC) Re-Connect

Behavioral

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).

Submission Contingent (SC) Re-Connect

Behavioral

Participants in this group will also be able to unblock their applications, but contingent on submitting CO samples and independent of meeting CO goals for smoking abstinence.

Primary outcomes

  1. 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.

  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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. Initial Acceptability

    Time frame: 1 day

    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.

Other outcomes

  1. Smartphone Use Moderators

    Time frame: 6-months

    Exploratory analyses will be conducted on potential moderator variables (e.g., baseline time spent on phone, number of apps downloaded/used, types of apps used).

Study contacts

Contact information is provided by the study sponsor or research team.

Bethany Raiff, PhD

CONTACT

[email protected]

856-256-4500 ext. 53782

Sponsors and collaborators

Lead sponsor

Rowan University

Other

Collaborators

  • University of Kentucky

Registry information

Official study title

Re-Connect Usability, Feasibility, Acceptability, and Preliminary Efficacy Testing

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Feb 4, 2022
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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