Nicotine Replacement Therapy for Quitting Smoking

Overseen By Bradley End, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: West Virginia University

Disqualifiers: Medically unstable, Uncontrolled psychiatric, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 2 weeks

Trial Summary

What is the purpose of this trial?

The objective of this study is to determine the effectiveness of ED initiated NRT on tobacco cessation point abstinence rates as reported by patients at 2 weeks and 1 month post randomization, and continued abstinence rates at 3 months compared to standard of care therapy.

Research Team

Bradley End

Principal Investigator

West Virginia University

Eligibility Criteria

This trial is for individuals who use tobacco and are seeking to quit, particularly those visiting the emergency department. Specific eligibility criteria details were not provided.

Inclusion Criteria

I can do phone or online check-ins when needed.

Reported English speaking

Current daily use cigarettes greater than or equal to ½ pack per day

Exclusion Criteria

Medically unstable patients

WVU students

I am unable to give consent by myself.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a 2-week supply of Nicotine Replacement Therapy (NRT) and a West Virginia Quit Line fact sheet/contact information

2 weeks

Follow-up

Participants are monitored for tobacco cessation point abstinence rates at 2 weeks, 1 month, and 3 months post randomization

3 months

Treatment Details

Interventions

• Nicotine Replacement Therapy

Trial Overview The study aims to test if starting Nicotine Replacement Therapy (NRT) in the emergency department helps people quit smoking better than the usual care. Success is measured by whether patients have stopped smoking after 2 weeks, 1 month, and at 3 months post-treatment.

Participant Groups

Group I: Control Non NRT Therapy Experimental Treatment 1 Intervention

Subject will be provided with a box/bag containing a WV QL fact sheet/contact information.

Group II: Nicotine Replacement Therapy (NRT) Active Control 2 Interventions

Subject provided with a 2-week supply of NRT and a West Virginia Quit Line (WV QL) fact sheet/contact information.

Nicotine Replacement Therapy is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as NRT for:

• Smoking cessation

Approved in European Union as NRT for:

• Smoking cessation

Approved in Canada as NRT for:

• Smoking cessation

Approved in Japan as NRT for:

• Smoking cessation

Who Is Running the Clinical Trial?

West Virginia University

Lead Sponsor

Trials

192

Recruited

64,700+