Opioids and Smoking Cessation

Plain-language guide to NCT03857139: phase 4 interventional trial of Therapeutic nicotine (patch, non-peptide). Who took part, design and what was measured.

Key Facts

Registry ID: NCT03857139
Phase: phase 4
Status: withdrawn
Start: 2020-12
Completion (planned or actual): 2022-01
Participants: n/a (actual)
Design: na, open label (everyone knows who gets what), treatment
Conditions studied: Smoking; Smoking Cessation; Smoking, Tobacco; Opioid Use; Opioid Abuse
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 4 trial tested Therapeutic nicotine (patch, non-peptide).

The selection hypothesis of smoking prevalence posits that smokers who are not able to quit successfully are "burdened" by specific characteristics that make it more challenging to quit1.

For example, those less successful in quitting smoking may be more nicotine dependent or more likely to suffer from substance use, psychiatric, or medical conditions.

It had 1 arm (groups): NRT smoking Cessation Intervention (experimental).

All participants will be provided with the Nicotine Patch as an intervention.

The registry classes the interventions as drug.

More on the Plan

The selection hypothesis of smoking prevalence posits that smokers who are not able to quit successfully are "burdened" by specific characteristics that make it more challenging to quit13.

Yet, there remains little understanding of the subgroups of "at-risk smokers" and the processes governing relapse among them14.

Prevalence of Comorbid Opioid Misuse and Tobacco Smoking.

Daily smokers are 5 times more likely than non-smokers to meet criteria for past year opioid misuse16.

Who Took Part

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: 1\. 18-65 years of age. 2. Daily smoker (≥ 10 cigarettes per day for at least one year), biochemically confirmed via Carbon Monoxide \[CO\] analysis at least 8 ppm. PDUQ \> 11, +POTQ, +urine toxicology screen.

The full record lists 2 inclusion and 1 exclusion criteria; among the exclusions: 1\. current use of psychotropic medication. 2. current use of nicotine replacement therapy, zyban, or chantix (or intention to use).

How the Study Was Run

Design: single-group and open-label.

Everyone knew when Therapeutic nicotine (patch, non-peptide) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2020-12 with completion listed for 2022-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Point Prevalence Abstinence (time frame: 3 months post-quit date).

What This Means in Plain Language

Put simply, this is a phase 4 trial of Therapeutic nicotine (patch, non-peptide) in people.

It was withdrawn before enrolling anyone; 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.

Our Notes on the Compound

Therapeutic nicotine (patch, non-peptide): Pure nicotine as a signaling tool, separated from smoking and vaping.

Therapeutic nicotine (patch, non-peptide) in the library

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.