Treating Smokers With Mental Illness

What Was Tested

This registered phase 2 trial tested Therapeutic nicotine (patch, non-peptide).

This is a smoking cessation study that will enroll smokers who have been diagnosed with a severe mental illness.

The study will use a combination of intensive tobacco treatment counseling and nicotine replacement therapy to assist smokers in cutting back on and quitting smoking over the course of six months.

It had two arms (groups): Intervention (experimental) and Control (other).

Intervention group will receive counseling and nicotine replacement therapy including the nicotine patch and/or nicotine lozenges.

Control group will receive information about mental illness and smoking cessation and a listing of community resources available for assistance with smoking cessation.

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

More on the Plan

At the baseline measurement visit, participants will be asked to complete a survey and an interview.

They will be randomly assigned to either the intervention or control group.

Both groups will receive a smoking cessation manual and list of resources.

The intervention group will also receive smoking cessation counseling and nicotine replacement therapy.

Who Took Part

Enrollment: 38 actual participants took part.

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

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

Examples of who could join: Have a severe mental illness diagnosis. Be a daily smoker. Want to try to quit smoking. Be willing to use nicotine replacement therapy. Be able to communicate in English.

The full record lists 6 inclusion and 4 exclusion criteria; among the exclusions: anyone who has had an active psychotic episode or been hospitalized due to suicidal ideation in the last six months; taking chantix or clozapine; having a terminal illness.

How the Study Was Run

It was run as a randomized, parallel-group and single-blind study.

Because people in this Therapeutic nicotine (patch, non-peptide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

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 2019-03-01 with completion listed for 2020-05-04.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: 7-Day Point Prevalence Abstinence (time frame: 8 weeks and 6 months post baseline).

It also tracked 2 secondary outcomes, for example Quit Attempts.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Therapeutic nicotine (patch, non-peptide) in 38 people.

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

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.