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Plain-language guide to NCT05290025: not phased randomized trial of Therapeutic nicotine (patch, non-peptide), 266 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT05290025
Phase
not phased
Status
active, not recruiting
Start
2022-04-07
Completion (planned or actual)
2023-10-31
Participants
266 (actual)
Design
randomized, single-blind, health_services_research
Conditions studied
Smoking Cessation; Substance-Related Disorders
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this not phased trial, researchers set out to test Therapeutic nicotine (patch, non-peptide).

It had two arms (groups): Intervention (experimental) and Intitial screening only (other).

Patients will be offered brief weekly behavioural interventions for smoking cessation and prescription-free nicotine replacement products in addidition standard opioid replacement therapy.

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

Who Took Part

266 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: Receiving OAT from an included outpatient clinic with weekly follow-up. Smoking at least one cigarette per day or seven cigarettes per week. Obtaining informed consent.

The full record lists 3 inclusion and 2 exclusion criteria; among the exclusions: allergies or prior anaphylactic reactions to medication used; smoking less than three times a week.

How the Study Was Run

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

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

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

Only one side, usually the participants, was kept unaware of whether Therapeutic nicotine (patch, non-peptide) was given.

Those kept unaware of assignments: outcomes assessor.

It started in 2022-04-07 with completion listed for 2023-10-31.

It ran at 2 sites in Norway (2).

Its stated primary purpose is health services research.

What Was Measured

Researchers chose this as the main measure: Smoking cessation (time frame: Mid of the intervention period 16 weeks after initiation).

It also tracked 9 secondary outcomes, for example impact on inflammation -CRP, impact on inflammation - leukocytes, Number of cigarettes smoked, CO-levels in exhaled air, Psychological distress and Fatigue Symptom Scale.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Therapeutic nicotine (patch, non-peptide) in 266 people.

Its status is active not recruiting; 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.

Related Pages

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.