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

University at Buffalo (UB)

Status and phase: Enrolling; Phase 3; Phase 2

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

Treatments: Drug: Combination Nicotine Replacement Therapy (patch and lozenge)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06822049

STUDY00008797 (SUNY-Buff IRB)

1UG3TR004797-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 4 patient groups

REMOTE intake AND REMOTE treatment/assessment

Other group

Description:

In this arm, ppts have been randomly assigned to a REMOTE INTAKE eligibility/baseline visit, and subsequently randomized to 5 REMOTE treatment/assessment visits.

Treatment:

Drug: Combination Nicotine Replacement Therapy (patch and lozenge)

REMOTE intake BUT IN-PERSON treatment/assessment

Other group

Description:

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.

Treatment:

Drug: Combination Nicotine Replacement Therapy (patch and lozenge)

IN-PERSON intake, BUT REMOTE treatment/assessment

Other group

Description:

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.

Treatment:

Drug: Combination Nicotine Replacement Therapy (patch and lozenge)

IN-PERSON intake AND IN-PERSON treatment/assessment

Other group

Description:

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.

Treatment:

Drug: Combination Nicotine Replacement Therapy (patch and lozenge)