Precision Pharmacotherapy Smoking Cessation Program

NCT04897607 | Completed Results

• 3 other identifiers: DDD# 604572U54GM104941CCC# 41042
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the benefits of a personalized treatment approach, compared to a non-personalized treatment approach, for smoking cessation. In other words, this study will help us know if recommending a specific medication to individual smokers will make it easier to quit smoking than simply offering an option of medications. The specific recommendation for a medication will be based on a test that measures how quickly a smoker breaks down, or metabolizes, nicotine.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Achieve Smoking Cessation

  Participants will report smoking status at the final assessment. Participants who self-report smoking cessation completed a carbon monoxide reading for biochemical confirmation of smoking status. The percentage of participants who achieve smoking cessation in each arm will be evaluated.

  4-week follow-up

Secondary Outcomes (3)

• Percentage of Participants Who Reported Using Smoking Cessation Medication (1-week)

  1-week follow-up

• Percentage of Participants Who Reported Using Smoking Cessation Medication (4-week)

  4-week follow-up

• Percentage of Participants Who Reported Use of a Smoking Medication That Matched Their NMR Profile

  1-week follow-up

Study Arms (2)

Treatment Plan Option 1 (Standard Care)

ACTIVE COMPARATOR

Standard smoking cessation counseling will be offered + participant choice of nicotine patches or varenicline. Participants are also free to decline either medication.

Behavioral: Standard Care

Treatment Plan Option 2 (Precision Pharmacotherapy)

EXPERIMENTAL

Standard smoking cessation counseling will be offered + a recommendation to take either the nicotine patch or varenicline based on the results of the NMR test. Regardless of the recommendation, it would still remain the participant's choice to be prescribed either nicotine patches or varenicline. Participants are also free to decline either medication.

Behavioral: Precision pharmacotherapy

Interventions

Standard Care BEHAVIORAL

Participants will be advised to quit smoking and offered a choice of nicotine replacement patches or varenicline. Participants are free to decline medication.

Treatment Plan Option 1 (Standard Care)

Precision pharmacotherapy BEHAVIORAL

Participants will be advised to quit smoking and provided a medication recommendation on the basis of their nicotine metabolite ratio (NMR) test (i.e., nicotine replacement patches for slower metabolizers, varenicline for faster metabolizers). Participants are free to choose either medication or decline any medication.

Treatment Plan Option 2 (Precision Pharmacotherapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• current smoker (5+ cigarettes/day)
• patient at the Helen F. Graham Cancer Center \& Research Institute (ChristianaCare) lung/thoracic clinic

You may not qualify if:

• use of non-cigarette tobacco products or smoking cessation treatment
• psychiatric or other medical contraindications to receiving smoking cessation medication
• no telephone
• medical instability
• inability to communicate in English
• unable to consent due to mental status
• estimated life expectancy of \<6 months
• not a Delaware resident
• pregnancy

Sponsors & Collaborators

• Christiana Care Health Services: lead
• University of Delaware: collaborator
• National Institute of General Medical Sciences (NIGMS): collaborator

Study Sites (1)

Helen F. Graham Cancer Center & Research Institute

Newark, Delaware, 19713, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Dr. Scott Siegel
• Organization: Christiana Care Health System

ssiegel@christianacare.org

302-623-4500

Study Officials

• Scott D Siegel, Ph.D.

  Christiana Care Health Services

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Population Health Research

Model Details: Patients will be randomized to the precision or standard care arms in a 1:1 ratio

Study Record Dates

• First Submitted: May 14, 2021
• First Posted: May 21, 2021
• Study Start: February 23, 2022
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 31, 2023
• Results First Posted: March 31, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)