Comparing Two Treatments That Both Target Smoking Cessation and Weight Loss at the Same Time.

What Was Tested

In this phase 1, phase 2 trial, researchers set out to test Therapeutic nicotine (patch, non-peptide).

The study has two phases.

In Phase 1, the investigators will revise and pilot the distress tolerance (DT) protocol that was originally developed and piloted in a previous study (2P20 GM103430, Spas, PI).

It had two arms (groups): Distress Tolerance (experimental) and Active Health Control (active comparator).

The registry classes the interventions as behavioral and drug.

More on the Plan

In Phase 1, the investigators will revise the distress tolerance (DT) protocol the investigators developed in a previous study.

Currently, the DT protocol is comprised of 6 two-hour weekly group sessions.

However, based on the data the investigators collected in the previous study, the investigators will revise the DT protocol to have 7 instead of 6 two-hour weekly group sessions. 6 subjects (1 group) will be recruited to pilot the revised DT protocol.

All subjects in the pilot will receive the transdermal nicotine patch (TNP).

Who Took Part

It was open to people of any sex aged from 18 years up to 64 years.

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

Examples of who could join: Between 18-64 years old. Have been a regular smoker for at least three years. Meet DSM-IV criteria for nicotine dependence. Smoke on average 10 cigarettes per day. Are overweight or obese (25\<BMI\<40).

The full record lists 7 inclusion and 7 exclusion criteria; among the exclusions: engaged in a smoking cessation or weight loss intervention; use medications known to affect smoking cessation or weight loss; have a medical condition that is a contraindication for transdermal nicotine patch (tnp).

How the Study Was Run

The set-up was randomized, single-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.

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

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

Those kept unaware of assignments: participant.

It started in 2019-06-01 with completion listed for 2022-07-31.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: 7-day point-prevalence abstinence from smoking (time frame: 6-month follow-up assessments from the end of intervention).

It also tracked 1 secondary outcome, for example Include latency to first smoking lapse and latency to smoking relapse.

What This Means in Plain Language

Put simply, this is a phase 1, phase 2, randomized 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.