NCT04897607

Precision Pharmacotherapy Smoking Cessation Program

Completed NA Results posted Last updated 31 March 2023

What this trial tests

NA trial testing Standard Care in Smoking Cessation in 37 participants. Completed in 31 December 2022.

Timeline

23 February 2022

Primary endpoint
31 December 2022

31 December 2022

Quick facts

Lead sponsor	Christiana Care Health Services
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	37
Start date	23 February 2022
Primary completion	31 December 2022
Estimated completion	31 December 2022
Sites	1 location across United States

Drugs / interventions tested

• Standard Care — full drug profile →
• Precision pharmacotherapy

Conditions studied

• Smoking Cessation — all drugs for Smoking Cessation →

Sponsor

Christiana Care Health Services — full company profile →

Who can join

18 and older, any sex, with Smoking Cessation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Who Achieve Smoking Cessation Primary · 4-week follow-up

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.

Group	Value	95% CI
Treatment Plan Option 1 (Standard Care)	1
Treatment Plan Option 2 (Precision Pharmacotherapy)	1

Percentage of Participants Who Reported Using Smoking Cessation Medication (1-week) Secondary · 1-week follow-up

Participants will report whether smoking cessation medication was used at the first week follow-up. The percentage of participants who used medication in each arm will be evaluated.

Group	Value	95% CI
Treatment Plan Option 1 (Standard Care)	11
Treatment Plan Option 2 (Precision Pharmacotherapy)	14

Percentage of Participants Who Reported Using Smoking Cessation Medication (4-week) Secondary · 4-week follow-up

Participants will report whether smoking cessation medication was used during 4 week follow up. The percentage of participants who used medication in each arm will be evaluated.

Group	Value	95% CI
Treatment Plan Option 1 (Standard Care)	4
Treatment Plan Option 2 (Precision Pharmacotherapy)	6

Percentage of Participants Who Reported Use of a Smoking Medication That Matched Their NMR Profile Secondary · 1-week follow-up

Participants will report which smoking cessation medication, if any, was used. Medication usage will be classified as matching their NMR profile as follows: slower metabolizer = nicotine replacement therapy, faster metabolizer = varenicline. The percentage of participants who matched in each arm will be evaluated.

Group	Value	95% CI
Treatment Plan Option 1 (Standard Care)	5
Treatment Plan Option 2 (Precision Pharmacotherapy)	11

Adverse events — posted to ClinicalTrials.gov

Time frame: General recruitment began in February 2022 - December 2022 (approximately 10 months). Patients who were enrolled received an initial baseline intake survey followed by appointments one week (Week 1) and four weeks (Week 4) after beginning their medication. Patient data for adverse events were collected during the patient's entire enrollment (approximately 6 weeks).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Treatment Plan Option 1 (Standard Care)

Serious: 0/17 (0%)

Deaths: 0/17

Treatment Plan Option 2 (Precision Pharmacotherapy)

Serious: 1/20 (5%)

Deaths: 1/20

Serious adverse events (1 terms)

Reaction	System	Treatment Plan Option 1 (S…	Treatment Plan Option 2 (P…
Pre-existing diabetes	Endocrine disorders	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	Treatment Plan Option 1 (S…	Treatment Plan Option 2 (P…
Nausea	Gastrointestinal disorders	—	—

Most-reported serious reactions: Pre-existing diabetes.

Data from ClinicalTrials.gov NCT04897607 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. A pilot pragmatic randomized controlled trial of a nicotine metabolite ratio-guided smoking cessation intervention in a lung health and screening program.
   Siegel SD, Budziszewski R, Layton E, Nam B, et al · · 2024 · PMID 39253369 · DOI 10.1016/j.dadr.2024.100275