Remote vs. In-PersonPhase 2/3NCT06822049

Remote vs. In-Person Study Evaluation (RISE) Trials: RISE Above Smoking (Trial 1 of 3)

A Phase 2/3 study testing Combination Nicotine Replacement Therapy (patch and lozenge) in people with Remote vs. In-Person and Remote Visits, run by State University of New York at Buffalo at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 99 yearsHealthy volunteers can take part
Conditions the study is for: Remote vs. In-Person, Remote Visits, In-person Visits
What is being tested?: Combination Nicotine Replacement Therapy (patch and lozenge)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: 2 sitesUnited States
Study dates: 10 Mar 2025to 27 Aug 2026
Phase: Phase 2/3
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 to 99 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Common to all 3 RCTs:
age18+ years
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)
able to read, speak \& verbally comprehend English
own an iOS or Android smartphone
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:
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

Who cannot join

Specific to RCT 1:
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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University at Buffalo
Buffalo, New York, 14260
University of Pennsylvania
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

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

The study will employ a randomized, parallel-group design with two-stage randomization. After an initial brief screen for basic eligibility, participants will be randomized (within site) to either Remote (R) or In-Person (IP) Intake Groups. During the Intake, detailed consent and eligibility assessment will be completed. Participants who are eligible at the Intake will be randomized (within site and Intake Group) to R or IP Treatment and Assessment Groups. Participants will be followed for 3 months.

Conditions: Remote vs. In-Person, Remote Visits, In-person Visits
Being tested: Combination Nicotine Replacement Therapy (patch and lozenge)
Keywords: Remote vs. In-Person methods

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Combination Nicotine Replacement Therapy (patch and lozenge)Drug
All participants receive 8 weeks of combination nicotine replacement therapy - long-acting transdermal patch and short-acting lozenge.

Study groups in NCT06822049
Study group	Role	What they receive
REMOTE intake AND REMOTE treatment/assessment	Other	In this arm, ppts have been randomly assigned to a REMOTE INTAKE eligibility/baseline visit, and subsequently randomized to 5 REMOTE treatment/assessment visits. Receives: Drug: Combination Nicotine Replacement Therapy (patch and lozenge)
REMOTE intake BUT IN-PERSON treatment/assessment	Other	In this arm, ppts have been randomly assigned to a REMOTE INTAKE eligibility/baseline visit, and subsequently randomized to 5 IN-PERSON treatment/assessment visits. Receives: Drug: Combination Nicotine Replacement Therapy (patch and lozenge)
IN-PERSON intake, BUT REMOTE treatment/assessment	Other	In this arm, ppts have been randomly assigned to an IN-PERSON INTAKE eligibility/baseline visit, and subsequently randomized to 5 REMOTE treatment/assessment visits. Receives: Drug: Combination Nicotine Replacement Therapy (patch and lozenge)
IN-PERSON intake AND IN-PERSON treatment/assessment	Other	In this arm, ppts have been randomly assigned to an IN-PERSON INTAKE eligibility/baseline visit, and subsequently randomized to 5 IN-PERSON treatment/assessment visits. Receives: Drug: Combination Nicotine Replacement Therapy (patch and lozenge)

What is being measured

The primary outcome is the main question the study is designed to answer.

Accrual efficiency/Pre-treatment visits
Calculated from visit milestones. Of participants who were eligible on the Brief Screen, the percentage who who attend the (Remote vs. In-Person) Intake Visit, a major accrual bottleneck for in-person trials. Although pre-treatment participant loss from Intake to Clinic 1 is typically modest, we will also explore Intake to T/A Visit 1 (first dose of treatment) attrition and overall pre-treatment attrition (from Brief Screen to T/A Visit 1) for each group.
Measured: ~1 month
Trial Quality: Retention
Retention will be assessed using visit milestone data to determine whether each participant achieved each T/A Visit (Visits 2-5) following T/A initiation at T/A Visit 1. We will calculate a continuous metric of retention (0-4; the number of visits completed) for each participant, supplemented by visit-specific data to provide a detailed examination of the time course and overall amount of retention.
Measured: ~3 months
Trial Quality: Treatment adherence/utilization (patient-reported)
Participants are instructed to use NRT patch and lozenge for 8 weeks, beginning on the date of T/A Visit 2 and ending the day before T/A Visit 4. Medication adherence will be assessed at T/A Visits 3 and 4 (end of NRT weeks 3 \& 8). Though we originally proposed to assess NRT use since the prior visit, we noted early in the trial that these data were problematic, as participants received their 2nd batch of medication before completing the 1st and often intermixed them. We decided to focus on past 7-day timeline followback (TLFB) interview reporting of NRT use: whether (yes/no) a patch was worn each day and number of lozenges used each day. From these data, we will compute for each participant the percent of days a nicotine patch was worn and the percent of days on which participants used 5+ lozenges (we recommended using 5+/day). A supplementary analysis will examine average number of lozenges per day.
Measured: 5 weeks (T/A Visits 3 and 4)
Trial quality: Biospecimen completion rates
The number of visits (out of 5; T/A Visits 1-5) for which the biospecimen (expired-air CO) is obtained by the clinical site.
Measured: 3 months (assessed at T/A Visits 1,2, 3, 4, and 5)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Mar 202527 Aug 2026

First posted12 Feb 2025
Study start10 Mar 2025
Primary completion27 Aug 2026
Study completion27 Aug 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Remote vs. In-PersonStudies of the same condition, open and under way.
More trials run by State University of New York at BuffaloThe 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 2/3
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: Randomized, parallel-group design. The study employs a two-stage adaptive biased-coin randomization technique. The initial randomization will be generated using a stratified biased coin design with an allocation probability of 0.75 and a randomization list within each stratum will be generated for both Stage I (randomization to remote vs in-person Intake) and Stage II (randomization to remote vs. in-person Treatment/Assessment visits). To optimize the balance in cell sizes across the 4 treatment conditions, the allocation probabilities will be adjusted at 3 study milestones (once 25%, 50%, and 75% of the target sample of 200 participants attend Treatment/Assessment Visit 1). Specifically, the allocation probability will be modified based on the imbalance in the number of participants across conditions who have attended Treatment/Assessment Visit 1.
Masking: None (open label)
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06822049
Sponsor's protocol ID: STUDY00008797 (SUNY-Buff IRB)
Other IDs: UH3TR004797
Status last verified: Sep 2026
First submitted: 6 Feb 2025
Last updated: 5 Nov 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: We plan to make available the full de-identified data set with metadata through the NAHDAP, a NIDA-funded platform for data sharing/archiving, with a topical focus on behavioral health data. NAHDAP operates under the umbrella of the ICPSR, based at the University of Michigan. Per the ICPSR website, the ICPSR is "the largest social science data archive in the world".

Publications

Hawk LW Jr, Schnoll RA, Dahne J, Carpenter MJ, Cropsey KL, Wilding GE, Duerr C, Allen CG, Nghiem VT, Shelton RC, Boccardo J, Foster CD, Mahoney MC. Remote vs. In-Person Study Evaluation (RISE) Trial 1 of 3 to examine the impact of decentralized trial methods on accrual efficiency, retention, biospecimen capture, and treatment utilization: study protocol for a multi-center randomized controlled trial in the context of smoking cessation (RISE Above Smoking). Trials. 2026 Jul 31;27(1):631. doi: 10.1186/s13063-026-09910-1.
PubMed 42947186

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Improving Efficiency, Quality, and Equity: Randomized Controlled Evaluations of Remote vs. In-Person Clinical Trial Methods; Remote vs. In-Person Study Evaluation (RISE) Trials
ClinicalTrials.gov ID: NCT06822049
Acronym / sponsor ID: STUDY00008797 (SUNY-Buff IRB)
Conditions: Remote vs. In-Person, Remote Visits, In-person Visits
Keywords: Remote vs. In-Person methods
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: State University of New York at BuffaloUniversity, hospital or other
Collaborators: Medical University of South Carolina, University of Pennsylvania, University of Alabama at Birmingham, National Center for Advancing Translational Sciences (NCATS), Abramson Cancer Center at Penn Medicine, Wake Forest University Health Sciences
Study start: 10 Mar 2025 (actual)
Primary completion: 27 Aug 2026 (actual)
Study completion: 27 Aug 2026 (actual)
First posted: 12 Feb 2025 (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.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4
Model description: Randomized, parallel-group design. The study employs a two-stage adaptive biased-coin randomization technique. The initial randomization will be generated using a stratified biased coin design with an allocation probability of 0.75 and a randomization list within each stratum will be generated for both Stage I (randomization to remote vs in-person Intake) and Stage II (randomization to remote vs. in-person Treatment/Assessment visits). To optimize the balance in cell sizes across the 4 treatment conditions, the allocation probabilities will be adjusted at 3 study milestones (once 25%, 50%, and 75% of the target sample of 200 participants attend Treatment/Assessment Visit 1). Specifically, the allocation probability will be modified based on the imbalance in the number of participants across conditions who have attended Treatment/Assessment Visit 1.

Arm	Type	Receives
REMOTE intake AND REMOTE treatment/assessment	Other	Drug: Combination Nicotine Replacement Therapy (patch and lozenge)In this arm, ppts have been randomly assigned to a REMOTE INTAKE eligibility/baseline visit, and subsequently randomized to 5 REMOTE treatment/assessment visits.
REMOTE intake BUT IN-PERSON treatment/assessment	Other	Drug: Combination Nicotine Replacement Therapy (patch and lozenge)In this arm, ppts have been randomly assigned to a REMOTE INTAKE eligibility/baseline visit, and subsequently randomized to 5 IN-PERSON treatment/assessment visits.
IN-PERSON intake, BUT REMOTE treatment/assessment	Other	Drug: Combination Nicotine Replacement Therapy (patch and lozenge)In this arm, ppts have been randomly assigned to an IN-PERSON INTAKE eligibility/baseline visit, and subsequently randomized to 5 REMOTE treatment/assessment visits.
IN-PERSON intake AND IN-PERSON treatment/assessment	Other	Drug: Combination Nicotine Replacement Therapy (patch and lozenge)In this arm, ppts have been randomly assigned to an IN-PERSON INTAKE eligibility/baseline visit, and subsequently randomized to 5 IN-PERSON treatment/assessment visits.

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Common to all 3 RCTs:
age18+ years
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)
able to read, speak \& verbally comprehend English
own an iOS or Android smartphone

Key exclusion criteria (2 listed)

Specific to RCT 1:

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
Combination Nicotine Replacement Therapy (patch and lozenge)All participants receive 8 weeks of combination nicotine replacement therapy - long-acting transdermal patch and short-acting lozenge.	Drug	IN-PERSON intake AND IN-PERSON treatment/assessment, IN-PERSON intake, BUT REMOTE treatment/assessment, REMOTE intake AND REMOTE treatment/assessment, REMOTE intake BUT IN-PERSON treatment/assessment

Primary outcome

Accrual efficiency/Pre-treatment visits
Time frame: ~1 month
Calculated from visit milestones. Of participants who were eligible on the Brief Screen, the percentage who who attend the (Remote vs. In-Person) Intake Visit, a major accrual bottleneck for in-person trials. Although pre-treatment participant loss from Intake to Clinic 1 is typically modest, we will also explore Intake to T/A Visit 1 (first dose of treatment) attrition and overall pre-treatment attrition (from Brief Screen to T/A Visit 1) for each group.
Trial Quality: Retention
Time frame: ~3 months
Retention will be assessed using visit milestone data to determine whether each participant achieved each T/A Visit (Visits 2-5) following T/A initiation at T/A Visit 1. We will calculate a continuous metric of retention (0-4; the number of visits completed) for each participant, supplemented by visit-specific data to provide a detailed examination of the time course and overall amount of retention.
Trial Quality: Treatment adherence/utilization (patient-reported)
Time frame: 5 weeks (T/A Visits 3 and 4)
Participants are instructed to use NRT patch and lozenge for 8 weeks, beginning on the date of T/A Visit 2 and ending the day before T/A Visit 4. Medication adherence will be assessed at T/A Visits 3 and 4 (end of NRT weeks 3 \& 8). Though we originally proposed to assess NRT use since the prior visit, we noted early in the trial that these data were problematic, as participants received their 2nd batch of medication before completing the 1st and often intermixed them. We decided to focus on past 7-day timeline followback (TLFB) interview reporting of NRT use: whether (yes/no) a patch was worn each day and number of lozenges used each day. From these data, we will compute for each participant the percent of days a nicotine patch was worn and the percent of days on which participants used 5+ lozenges (we recommended using 5+/day). A supplementary analysis will examine average number of lozenges per day.
Trial quality: Biospecimen completion rates
Time frame: 3 months (assessed at T/A Visits 1,2, 3, 4, and 5)
The number of visits (out of 5; T/A Visits 1-5) for which the biospecimen (expired-air CO) is obtained by the clinical site.

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 5 Nov 2026.
Derived from this study: PubMed 42947186Hawk LW Jr, Schnoll RA, Dahne J, Carpenter MJ, Cropsey KL, Wilding GE, Duerr C, Allen CG, Nghiem VT, Shelton RC, Boccardo J, Foster CD, Mahoney MC. Remote vs. In-Person Study Evaluation (RISE) Trial 1 of 3 to examine the impact of decentralized trial methods on accrual efficiency, retention, biospecimen capture, and treatment utilization: study protocol for a multi-center randomized controlled trial in the context of smoking cessation (RISE Above Smoking). Trials. 2026 Jul 31;27(1):631. doi: 10.1186/s13063-026-09910-1.
Individual participant dataSharing planned: Yes. We plan to make available the full de-identified data set with metadata through the NAHDAP, a NIDA-funded platform for data sharing/archiving, with a topical focus on behavioral health data. NAHDAP operates under the umbrella of the ICPSR, based at the University of Michigan. Per the ICPSR website, the ICPSR is "the largest social science data archive in the world".

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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.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 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 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Accrual efficiency/Pre-treatment visits (time frame: ~1 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06822049, which also lists 1 linked publication.

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 5 Nov 2026.