About this trial

The main goal of the present study is to determine if a smoking cessation program designed for people living with certain chronic conditions and delivered via videoconferencing groups works better than a control condition--a program that is not designed to help with smoking but that does have the same number of group contact hours as the other program (this program is called the Attention Matched Control condition; AMC) for helping people with certain health conditions stop smoking. People in both groups will receive brief advice to quit and an offer of nicotine replacement therapy patches (NRT), as well as 12 videoconferencing group sessions. The team will measure smoking behavior over a one-year period and compare smoking rates for the treatment condition against AMC to see if the treatment condition is better at getting people living with certain health conditions to quit smoking.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

greater than or equal to age 18 (as NRT is not FDA approved for adolescents)

self-report smoking cigarettes

positive cotinine test

motivated to quit

Disqualifiers

pregnant, breastfeeding, or have other contraindications to NRT

receiving other tobacco treatment, or

inability to communicate coherently in English during the video-conferencing test or other pre-enrollment interactions

Trial design

Design model

Parallel

Treatments tested in this trial

Positively Me
Behavioral
12 session smoking cessation intervention based on Social Cognitive Theory, designed for people with certain health conditions (8 primary sessions, followed by 4 booster sessions)
Positively Living
Behavioral
12 session healthy living intervention based on Social Cognitive Theory, designed for people with certain health conditions (8 primary sessions, followed by 4 booster sessions)

Treatment groups

482 Participants

are divided into 2 treatment groups

Group A: Positively MeExperimental treatment 1 intervention

Group B: Positively LivingSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Biochemically confirmed 7-day point prevalence abstinence (BC7ppa) day 360

Participant is asked if she has smoked a cigarette, even a puff, in the past 7 days. If she reports abstinence, she also completes a cotinine swab test over video-conferencing to determining cotinine levels. Levels less than 10ng/ml will be considered abstinence. BC7ppa will be coded as abstinence-indicating if she answers "no" to the question and cotinine levels suggest abstinence.

Time frame

study day 360

2

Biochemically confirmed 30-day point prevalence abstinence (BC30ppa) day 360

Participant is asked if she has smoked a cigarette, even a puff, in the past 30 days. If she reports abstinence, she also completes a cotinine swab test over video-conferencing to determining cotinine levels. Levels less than 10ng/ml will be considered abstinence. BC30ppa will be coded as abstinence-indicating if she answers "no" to the question and cotinine levels suggest abstinence.

Time frame

study day 360

3

Biochemically confirmed sustained abstinence (BC.SA) day 360

At day 42 (2 weeks post-quit day; provides a grace period), participant is asked the BC7ppa question (see outcome 1). Then, at each full and brief assessment going forward, beginning at day 90, participant is asked if she has smoked a cigarette, even a puff, since the last assessment. If she reports abstinence, she also completes a cotinine swab test over video-conferencing to determining cotinine levels. Levels less than 10ng/ml will be considered abstinence. BC.SA will be coded as abstinence-indicating if she answers "no" to the sustained abstinence question at each assessment and cotinine levels at each assessment suggest abstinence.

Time frame

Study day 360

Secondary outcomes

1

Biochemically confirmed 7-day point prevalence abstinence (BC7ppa) day 42

Participant is asked if she has smoked a cigarette, even a puff, in the past 7 days. If she reports abstinence, she also completes a cotinine swab test over video-conferencing to determining cotinine levels. Levels less than 10ng/ml will be considered abstinence. BC7ppa will be coded as abstinence-indicating if she answers "no" to the question and cotinine levels suggest abstinence.

Time frame

study day 42

2

Biochemically confirmed 7-day point prevalence abstinence (BC7ppa) day 90

Participant is asked if she has smoked a cigarette, even a puff, in the past 7 days. If she reports abstinence, she also completes a cotinine swab test over video-conferencing to determining cotinine levels. Levels less than 10ng/ml will be considered abstinence. BC7ppa will be coded as abstinence-indicating if she answers "no" to the question and cotinine levels suggest abstinence.

Time frame

study day 90

3

Biochemically confirmed 7-day point prevalence abstinence (BC7ppa) day 180

Participant is asked if she has smoked a cigarette, even a puff, in the past 7 days. If she reports abstinence, she also completes a cotinine swab test over video-conferencing to determining cotinine levels. Levels less than 10ng/ml will be considered abstinence. BC7ppa will be coded as abstinence-indicating if she answers "no" to the question and cotinine levels suggest abstinence.

Time frame

study day 180

4

Biochemically confirmed 30-day point prevalence abstinence (BC30ppa) days 90

Participant is asked if she has smoked a cigarette, even a puff, in the past 30 days. If she reports abstinence, she also completes a cotinine swab test over video-conferencing to determining cotinine levels. Levels less than 10ng/ml will be considered abstinence. BC30ppa will be coded as abstinence-indicating if she answers "no" to the question and cotinine levels suggest abstinence.

Time frame

study day 90

The Positively Quit Trial for Smoking Cessation

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts