Comparative Tobacco Interventions for Individuals With Severe and Persisting Behavioral Health Disorders

Study Details

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.

Conditions

Tobacco Use

Study ID

NCT04523948

Start date

Jan 30, 2020

Status verified date

Sep, 2021

Completion date

Jul 31, 2023

Anticipated

Primary completion date

Oct 31, 2022

Anticipated

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Individuals who are formerly or currently being served by San Francisco Bay Area Public Health behavioral health providers. These will include individuals with psychotic, affective, anxiety, personality and substance use disorders.
Individuals who are not currently enrolled in another formal tobacco intervention or research study.
Are at least 21 years of age and able to speak English\*
Who score in the "low to moderate dependence" range on the Fagerstrom Test of Nicotine Dependence
Have used tobacco for at least two years
Express willingness to participate at least weekly in the intervention strategy
Express a desire to make some change in their tobacco use pattern
Express some reason to change their tobacco use pattern
Have the cognitive capacity to be able to sign a consent to participate in the research

A concerted effort will be made to recruit bilingual Chinese and Spanish language staff

Exclusion Criteria:

The individual does not currently smoke tobacco
Individuals younger than 21 years of age at the time of enrollment
Who score in the "low" range on the Fagerstrom Test of Nicotine Dependence
Have used tobacco for less than two years;
Express unwillingness to participate at least weekly in the intervention strategy
Decline an interest in making some change in their tobacco use pattern
Do not indicate the cognitive capacity to be able to sign a consent to participate in the research

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Cohort Two

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.

Cohort Three

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.

Cohort Four

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.

Cohort Five

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.

Interventions

Behavioral and pharmacological support to reduce combustible tobacco use.

Primary outcome measure

Number of cigarettes smoked [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 ]