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Contingency Management for Smoking Cessation in Homeless Smokers

Plain-language guide to NCT01789710: not phased non-randomized trial of Therapeutic nicotine (patch, non-peptide), 25 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT01789710
Phase
not phased
Status
completed
Start
2013-01
Completion (planned or actual)
2014-09
Participants
25 (actual)
Design
non-randomized, open label (everyone knows who gets what), treatment
Conditions studied
Smoking; Homeless Persons
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (not phased) is built around Therapeutic nicotine (patch, non-peptide).

Thirty homeless smokers will be enrolled in the study.

Participants will receive payment based on their own low carbon monoxide readings, which indicate being quit from smoking.

It had 1 arm (groups): Active Contingency Management (experimental).

All participants are assigned to a single arm, active contingency management. In this arm, participants are provided monetary rewards for remaining abstinent from smoking.

The registry classes the interventions as behavioral and drug.

Who Took Part

25 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Must be a Veteran who is eligible for care within the VA system;. Must be currently homeless or have been homeless more than twice in the past year period;. Must have current smoking status of at least 10 cigarettes per day for at least 1 year (verified with breath carbon monoxidemeasurement);. Must be aged 18 to 70;. Must be English speaker.

The full record lists 5 inclusion and 8 exclusion criteria; among the exclusions: urine drug screen results positive for cocaine, amphetamines, stimulants, opioids, or hallucinogens;; not stable on medications for the study period;; use of any other forms of nicotine such as cigars, pipes, or chewing tobacco;.

How the Study Was Run

The set-up was non-randomized, single-group and open-label.

Nothing was hidden in this open-label Therapeutic nicotine (patch, non-peptide) study: the participants and staff both knew the treatment.

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

It started in 2013-01 with completion listed for 2014-09.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Breath carbon monoxide (time frame: Throughout study - one year).

It also tracked 1 secondary outcome, for example Saliva cotinine.

What This Means in Plain Language

Put simply, this is a not phased, non-randomized trial of Therapeutic nicotine (patch, non-peptide) in 25 people.

Its size is small, so on its own it can only give an early look.

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.

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.