Comparing remote and in-person methods for smoking cessation

Improving Efficiency, Quality, and Equity: Randomized Controlled Evaluations of Remote vs. In-Person Clinical Trial Methods; Remote vs. In-Person Study Evaluation (RISE) Trials

This study tests whether quitting smoking is more effective with remote support or in-person help for people trying to stop smoking.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 99 Years
• Sex: All
• Sponsor: State University of New York at Buffalo (Academic / other)
• Locations: 2 sites (Buffalo, New York and 1 other locations)
• Trial ID: NCT06822049 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of remote versus in-person methods for smoking cessation using a randomized, parallel-group design. Participants will be screened for eligibility and then randomized to either a remote or in-person intake group. Those who qualify will receive combination nicotine replacement therapy and will be followed for three months to assess outcomes. The goal is to determine which method is more effective in helping smokers quit.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 who smoke more than five cigarettes a day and are motivated to quit.

Not a fit: Patients who do not smoke daily or have significant allergies to nicotine replacement therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the most effective methods for supporting smoking cessation, potentially improving quit rates.

How similar studies have performed: Other studies have shown promise in using remote methods for smoking cessation, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Common to all 3 RCTs:

Inclusion criteria:

1. age18+ years
2. stable mailing address (for mailing study packets if assigned to Remote Intake and/or Remote Treatment/Assessment) within accessible range (1.5 hours) of each study site (per self report)
3. able to read, speak \& verbally comprehend English
4. own an iOS or Android smartphone
5. have a valid e-mail address that is checked regularly or have regular access to text messages (to access follow-up assessments)

Specific to RCT 1:

Inclusion criteria:

a) daily cigarette smoker of 5+ cigarettes/day for 6+ months b) moderate or greater motivation to quit smoking (6+ on the Motivation to Stop Smoking Scale) d) agree to refrain from use of other tobacco products and use of non-study cessation treatments while participating in the trial e) Willing to be randomized to attend remote/in-person visits

Exclusion Criteria:

* Specific to RCT 1:

  a) use of tobacco/nicotine products other than cigarettes (except blunts, spliffs, cigars, little cigars, cigarillos) for average of 5\_ days per week over the past 3 months b) prior allergy/intolerance to NRT patch or lozenge c). pregnant, breastfeeding, or planning to become pregnant in next 4 months d) use of varenicline, NRT (e.g., patch, gum, lozenge), or bupropion in past 7 days for purpose of quitting smoking e) consumption of \>28 alcohol-containing drinks per week g) high risk involvement with illicit or nonmedical prescription drugs (NIDA-modified ASSIST=27+) h) suicide attempt with at least some wish to die in past 3 months i) mental illness (such as schizophrenia, bipolar disorder, or major depression) that led to hospitalization in the past 30 days j) unable/unwilling to provide informed consent or follow directions, inappropriately responsive, based on staff observations k) for participants age 21+: refusal to provide/show a pack of cigarettes for documentation at the intake visit

Where this trial is running

Buffalo, New York and 1 other locations

• University at Buffalo — Buffalo, New York, United States (Recruiting)
• University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)

Study contacts

• Study coordinator: Larry W Hawk, PhD

Conditions Remote vs. In-Person; Remote Visits; In-person Visits; Remote vs. In-Person methods