Metabolism-informed Care for Smoking Cessation

What Was Tested

This registered not phased trial tested Therapeutic nicotine (patch, non-peptide).

Nicotine mediates smoking's addictive effects in the brain.

The ratio of 3-hydroxycotinine to cotinine, known as the nicotine metabolite ratio, or NMR, is a genetically- informed biomarker reflecting hepatic CYP2A6 activity and the rate of nicotine metabolism.

It had two arms (groups): Metabolism-Informed Care (MIC) (active comparator) and Guideline-Based Care (GBC) (active comparator).

The registry classes the interventions as drug and other.

More on the Plan

All participants received counseling from a nurse level certified tobacco counseling.

After consent, participants undergo a blood draw for NMR, complete a baseline questionnaire, and are randomized to GBC or MIC.

At approximately 1, 3, and 6 months post-consent, participants will provide follow up information via telephone questionnaire regarding symptoms, confidence in quitting, use of medications, and smoking status.

At the 6-month follow-up time point, if a participant self-reports abstinence from smoking, the participant will be asked to complete a survey in-person and provide a sample of end-expired carbon monoxide for biochemical validation.

Who Took Part

The registry lists 82 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 18 years or older. Smokes ≥ 5 cigarettes per day. Willing to give up all forms of tobacco (5/10/2016 - 6/27/2016).

The full record lists 5 inclusion and 9 exclusion criteria; among the exclusions: current diagnosis of schizophrenia, psychosis, active suicidal ideation, dementia, or severe mental retardation; receiving palliative or hospice care; currently pregnant or breastfeeding.

How the Study Was Run

It was run as a randomized, crossover and triple-blind study.

Random assignment meant chance, not the researchers, decided who got Therapeutic nicotine (patch, non-peptide) and who got the comparison, which limits bias.

Each person switched between Therapeutic nicotine (patch, non-peptide) and the comparison at some point, usually with a gap in between.

Blinding on both sides kept the participants and researchers unaware of who received Therapeutic nicotine (patch, non-peptide).

Those kept unaware of assignments: participant, care provider and outcomes assessor.

It started in 2016-05-18 with completion listed for 2016-10-08.

Its stated primary purpose is health services research.

What Was Measured

The main thing measured (primary outcome): Theoretical Endorsement of MIC as assessed by level of agreement to a set of seven 5-point Likert Scale questions (time frame: Baseline). Acceptance of MIC medication recommendation as assessed by concordance between MIC recommendation and actual prescribed medication (time frame: At 4 weeks post-baseline).

It also tracked 3 secondary outcomes, for example Confidence in Quitting, Medication Use/Compliance and Smoking Status.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Therapeutic nicotine (patch, non-peptide) in 82 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Therapeutic nicotine (patch, non-peptide) compound page, all human trials.