Brief Summary

The aim of this pilot intervention is to examine the acceptability of a harm reduction intervention approach to tobacco use for individuals with serious behavioral health disorders and its association with a decrease in smoking. The intervention uses a "dynamic" approach to patient choice, allowing participants the option to explore different strategies for harm reduction, while providing support from counselors in the process. Therefore, the investigators have chosen an observational study design in order to document and explore the acceptability and outcomes of the intervention.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

100

participants targeted

Target at P50-P75 for all trials

Timeline

Completed

Started Jan 2020

Typical duration for all trials

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

3.5 years study duration

Study Start

First participant enrolled

January 30, 2020

Completed

6 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2020

Completed

1 month until next milestone

First Posted

Study publicly available on registry

August 24, 2020

Completed

2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed

9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed

Last Updated

September 28, 2021

Status Verified

September 1, 2021

Enrollment Period

2.8 years

First QC Date

July 23, 2020

Last Update Submit

September 22, 2021

Conditions

Tobacco Use

Keywords

Mental HeatlhSubstance UseHarm Reduction

Outcome Measures

Primary Outcomes (4)

Number of cigarettes smoked
Self-reported number of cigarettes smoked per day
Change in number of cigarettes smoked per day will be assessed using two time frames: 1) Baseline to 6 months post baseline; and 2) Post intervention which is change from baseline to 12 months post baseline.
Nicotine Dependence
Fagerström Test for Nicotine Dependence, a self-reported scale rated from 0-10, with \>=5 indicating dependence (Heatherton et al., 1991).
Change in nicotine dependence will be assessed using two time frames: 1) during the intervention, which is change from baseline to 6 months post baseline; and 2) after the intervention which is change from baseline to 12 months post baseline
Carbon Monoxide
Exhaled carbon monoxide level concentration reported in parts per million (ppm) using a breathalyzer assay
Change in carbon monoxide level will be assessed using two time frames: 1) during the intervention, which is change from baseline to 6 months post baseline; and 2) after the intervention which is change from baseline to 12 months post baseline
Salivary Tobacco Use
Salivary tobacco use level reported in nicotine metabolites (cotinine)
Change in salivary nicotine level will be assessed using two time frames: 1) during the intervention, which is change from baseline to 6 months post baseline; and 2) after the intervention which is change from baseline to 12 months post baseline

Secondary Outcomes (3)

Smoking Decisional Balance
Change in smoking decisional balance will be assessed using two time frames: 1) during the intervention, which is change from baseline to 6 months post baseline; and 2) after the intervention which is change from baseline to 12 months post baseline
Challenges to Smoking Behavior Change
Change in challenges to smoking behavior change will be assessed on two occasions: 1) during the intervention from baseline to 6 months post baseline; and 2) after the intervention which is change from baseline to 12 months post baseline.
Working Alliance Inventory
Change in working alliance quality will be assessed using two time frames: 1) during the intervention, which is change from baseline to 6 months post baseline; and 2) after the intervention which is change from baseline to 12 months post baseline.

Study Arms (5)

Cohort One

Subjects will be invited to participate in brief weekly in person or telehealth behavioral support with the objective of reducing their rate of combustible tobacco use. Subjects will also be offered the choice of various conventional nicotine replacement aids, snus, electronic cigarette, varenicline or bupropion.