Persistence Targeted Smoking Cessation in Serious Mental Illness (SMI)

What Was Tested

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

It had 1 arm (groups): NRT + Persistence Targeted Smoking Cessation in SMI (experimental).

Participants will receive 10 weeks of nicotine patch (NRT) plus 8 weeks of task persistence focused cessation counseling delivered via telehealth.

The registry classes the interventions as behavioral and drug.

More on the Plan

The researchers will provide free, weekly individual telehealth video counseling sessions for 8 weeks and 10-weeks' worth of the nicotine transdermal patch (an FDA-approved smoking cessation product available over the counter).

All sessions will be video recorded for treatment integrity and supervision.

The investigators hypothesize that 1) the PTSC-S intervention will be acceptable to participants, and the study will be feasible to conduct.

The researchers will report prolonged and point prevalence abstinence rates at end-of-counseling and at 3-month follow-up (CO verified \<8ppm).

Who Took Part

The registry lists 34 actual participants took part.

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

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

Examples of who could join: Must be between 18 - 70 years old. Must indicate willingness to make a quit attempt in the next 30 days. Must report being a daily cigarette smoker (including those labeled "little cigars") for past month. Must have a diagnosis of Schizophrenia, Schizoaffective Disorder, or Bipolar Disorder on the Structured Clinical Interview for Diagnostic and Statistical Manual (DSM), 5th edition, Research Version (SCID-5-RV). Psychiatric illness must be stable, as indicated by no hospitalizations in previous 8 weeks, and a stable psychotropic medication regimen for 8 weeks.

The full record lists 8 inclusion and 9 exclusion criteria; among the exclusions: must not currently (in past 10 days) be taking varenicline (chantix),; must not currently (in past 10 days) be taking bupropion (zyban/wellbutrin) to quit smoking; must not be taking any nicotine preparations (gum, lozenge, patch, spray, inhaler) daily over the last 10 days.

How the Study Was Run

The set-up was 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 2019-04-22 with completion listed for 2022-01-10.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Acceptability 1: Participant Rating of Usefulness of Intervention (time frame: 3-months post quit date (approximately 4-months after baseline assessment)). Acceptability 2: Participant Rating of Counseling Session Length (time frame: 3-months post quit date (approximately 4 months after baseline assessment)). Acceptability 3: Participant Rating of Treatment Length / Timing of Target Quit-Date (time frame: 3-months post quit date (approximately 4 months after baseline assessment)).

It also tracked 6 secondary outcomes, for example Number of Participants With Seven-day Point Prevalence Abstinence at End-of-counseling, Number of Participants With Prolonged Abstinence at End-of-counseling, Number of Participants With Seven-day Point Prevalence Abstinence at 3-month Follow-up, Number of Participants With Prolonged Abstinence at at 3-month Followup, Task Persistence Scores and Cigarettes Per Day.

What This Means in Plain Language

Put simply, this is a not phased trial of Therapeutic nicotine (patch, non-peptide) in 34 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.