Nicotine Replacement Therapy for Smoking Cessation

Recruiting at 1 trial location

Overseen By Larry W Hawk, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2 & 3

Waitlist Available

Sponsor: State University of New York at Buffalo

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for individuals who want to quit smoking and are willing to try nicotine replacement therapy. Participants must pass a basic eligibility screen and can attend either remote or in-person sessions. Specific inclusion and exclusion criteria details were not provided.

Inclusion Criteria

I am older than 18 years.

Stable mailing address within accessible range of each study site

I can read, speak, and understand English well.

Exclusion Criteria

Use of tobacco/nicotine products other than cigarettes more than once per week (specific to RCT 1)

Past-year suicide attempt (specific to RCT 1)

Prior allergy/intolerance to NRT patch or lozenge (specific to RCT 1)

Treatment Details

Interventions

• Combination Nicotine Replacement Therapy (Nicotine Replacement Therapy)

Trial Overview The RISE Above Smoking trial is testing the effectiveness of combination nicotine replacement therapy (patches and lozenges) through two settings: remotely or in-person. Participants will be randomly assigned to one of these groups after an initial screening, with follow-ups over three months.

Participant Groups

Group I: REMOTE intake BUT IN-PERSON treatment/assessment Experimental Treatment 1 Intervention

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.

Group II: REMOTE intake AND REMOTE treatment/assessment Experimental Treatment 1 Intervention

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

Group III: IN-PERSON intake, BUT REMOTE treatment/assessment Experimental Treatment 1 Intervention

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.

Group IV: IN-PERSON intake AND IN-PERSON treatment/assessment Experimental Treatment 1 Intervention

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 Is Running the Clinical Trial?

State University of New York at Buffalo

Lead Sponsor

Trials

279

Recruited

52,600+

Medical University of South Carolina

Collaborator

Trials

994

Recruited

7,408,000+

University of Pennsylvania

Collaborator

Trials

2,118

Recruited

45,270,000+

University of Alabama at Birmingham

Collaborator

Trials

1,677

Recruited

2,458,000+

National Center for Advancing Translational Sciences (NCATS)

Collaborator

Trials

394

Recruited

404,000+

Abramson Cancer Center at Penn Medicine

Collaborator

Trials

425

Recruited

464,000+