PRecision Interventions for SMoking in the SCCS

What Was Tested

The trial (phase 2, phase 3) is built around Therapeutic nicotine (patch, non-peptide).

Precision Care (PC) interventions, developed with guidance from a Community Advisory Board (CAB), will be piloted in a Randomized Clinical Trial (RCT) of approximately 100 eligible, consenting daily smokers in the Southern Community Cohort Study (SCCS) who are willing to make a quit attempt with medication and who reside in TN or MS.

Participants will be randomized 1:1:1 to 1 of 3 groups; (1) group one informs selection of medication with information on nicotine metabolism; (2) group two offers a genetically-informed lung cancer risk score, and (3) group 3 is Guideline-Based Care (GBC).

All groups will be followed for 6 months.

It had three arms (groups): Guideline-Based Care (GBC) (other), Nicotine Metabolite Ratio (PC-NMR) (active comparator) and Respiragene (PC-Respiragene) (active comparator).

Group 1, nicotine metabolism. Medication is guided by nicotine metabolism.

Group 2, genetically-informed lung cancer risk score. Medication assignment is guided by standard guidelines and a conversation between the study nurse and the participant.

The registry classes the interventions as behavioral, drug and genetic.

More on the Plan

These participants will then mail in written consent, upon receipt of which their SCCS stored blood samples will be analyzed.

During lab processing, a study tobacco counselor will call enrolled participants to assist with their quit plan and inform them of randomization status.

Participants will complete telephone surveys at 1, 3, and 6 months.

During the 6 month follow-up call, participants will also be given their previously-unreported lab results (i.e., information on nicotine metabolism or lung cancer risk).

Who Took Part

The registry lists 67 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: Daily smoker of ≥5 cigarettes per day (CPD). Enrolled participant of the Southern Community Cohort Study (SCCS) who completed a prior survey indicating they were willing to be contacted regarding a smoking cessation clinical trial. Has stored blood sample with the SCCS. Has established primary care provider (PCP).

The full record lists 6 inclusion and 9 exclusion criteria; among the exclusions: currently taking medication to quit smoking; enrolled, or planning to be enrolled, in another smoking cessation program; inability to give informed consent or participate due to cognitive disorder (e.g., dementia, severe intellectual disability).

How the Study Was Run

Design: randomized, parallel-group and single-blind.

The participants were allocated by chance, so the Therapeutic nicotine (patch, non-peptide) group and the comparison group should start out alike.

The Therapeutic nicotine (patch, non-peptide) group and the comparison group ran side by side rather than switching.

In this single-blind Therapeutic nicotine (patch, non-peptide) study one party knew the assignments and the other did not.

Those kept unaware of assignments: outcomes assessor.

It started in 2018-05-18 with completion listed for 2019-04-11.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Intervention Feasibility: Ability to Retain Participants (time frame: Full trial: Baseline - 6 month survey).

It also tracked 5 secondary outcomes, for example Cessation History - Quit Attempts, Cessation History - Medication Use, Cessation History - Quitline, Cessation History - Self-reported Abstinence and Cessation History - Validated Abstinence.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Therapeutic nicotine (patch, non-peptide) in 67 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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