Tobacco UsePTSC-SNCT03873337
Persistence Targeted Smoking Cessation in Serious Mental Illness (SMI)
A study testing Persistence Targeted Smoking Cessation in SMI (PTSC-S) and Nicotine patch in people with Tobacco Use and Tobacco Smoking, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
Due to the pandemic, this study was modified from a randomized clinical trial to test the feasibility, initial efficacy, and mechanisms of action of our PTSC-S intervention to a feasibility and acceptability test of our intervention when delivered via telehealth in a single group, within-subjects design. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tobacco Use, Tobacco Smoking, Tobacco Use Cessation
- What is being tested?
- Persistence Targeted Smoking Cessation in SMI (PTSC-S) and Nicotine patch
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2019to 31 Jan 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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
- Must have a smartphone, tablet, or computer with ability to download apps
- Must currently receive mental health treatment
- Must sign release of information for current mental health treatment providers
Who cannot join
- 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
- Must not report myocardial infarction, unstable angina pectoris, or significant cardiac arrhythmia (including atrial fibrillation) in the past 30 days.
- Women must not be pregnant, "test positive" on a pregnancy test, nursing, or planning on becoming pregnant in the next three months. Women who can become pregnant may be included if using effective birth control.
- Must not have pending legal matters with potential to result in jail time
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- Must not be planning on moving outside local area in next 3-months
- Problematic substance use in the past 3 months (Alcohol Use Disorders Identification Test-Concise (AUDIT-C) ≥5 for men and ≥4 for women, Drug Abuse Screening Test (DAST-10) score of ≥4)
- Must not have suicidal ideation in the past week with intent, plan, or access to method; must not have attempted suicide in the past year (as assessed on the SCID-RV)
Trial locations and contacts
1 site in 1 country.
United States1 site
Division of Addiction Psychiatry
New Brunswick, New Jersey, 08901
About this study
Official title: Persistence Targeted Smoking Cessation in Schizophrenia (PTSC-S)
Due to the pandemic, this study was modified from a randomized clinical trial to test the feasibility, initial efficacy, and mechanisms of action of our PTSC-S intervention to a feasibility and acceptability test of our intervention when delivered via telehealth in a single group, within-subjects design.
Read the detailed description
The investigators will test the feasibility and acceptability of a telehealth-delivered treatment designed to help smokers with serious mental illness to quit using a therapy approach focused on increasing task persistence.
We 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. We will report prolonged and point prevalence abstinence rates at end-of-counseling and at 3-month follow-up (CO verified <8ppm).
- Conditions
- Tobacco Use, Tobacco Smoking, Tobacco Use Cessation, Tobacco Use Disorder, Schizophrenia, Schizoaffective Disorder
- Being tested
- Persistence Targeted Smoking Cessation in SMI (PTSC-S), Nicotine patch
- Keywords
- tobacco, cigarette, schizophrenia, schizoaffective disorders, smoking cessation
- Medical subject headings
- Tobacco Use, Tobacco Smoking, Tobacco Use Cessation, Tobacco Use Disorder, Schizophrenia, Psychotic Disorders, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Persistence Targeted Smoking Cessation in SMI (PTSC-S)Behavioural
All participants will receive 8 weeks of persistence focused smoking cessation counseling delivered via telehealth
Nicotine patchDrug
All participants will receive 10 weeks of nicotine patch
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Persistence Targeted Smoking Cessation in SMI (PTSC-S); Drug: Nicotine patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability 1: Participant Rating of Usefulness of Intervention
After each session, participants (N=33) provided a 1-7 rating of how "easy to understand" and how "helpful" the intervention was. Higher numbers represent greater ease and greater helpfulness, respectfully. There is no official scale title because the scale was developed for this study.
Measured: 3-months post quit date (approximately 4-months after baseline assessment)
Acceptability 2: Participant Rating of Counseling Session Length
After each session, participants (N=33) provided a 1-7 rating of agreement with the statement, "There was too much information in today's session." (as a proxy for appropriateness of session length). Higher numbers represent greater agreement. There is no official scale title because the scale was developed for this study.
Measured: 3-months post quit date (approximately 4 months after baseline assessment)
Acceptability 3: Participant Rating of Treatment Length / Timing of Target Quit-Date
We asked participants how acceptable the placement of the target quit date was to participants (i.e., it was scheduled for session 4). We report the percentage of participants who responded that the quit date was "too soon", "too late", or "just about right".
Measured: 3-months post quit date (approximately 4 months after baseline assessment)
Feasibility 1: Number of Participants Contacted at 3 Months Post-Quite Date
We will calculate follow-up rates to determine if they meet our goal of 80% follow-up rates at the 3-month follow-up.
Measured: 3-months post quit date (approximately 4 months after baseline assessment)
Feasibility 2: Missing/Unusable Data
We will determine the rate of missing or unusable carbon monoxide (CO) data to determine if the rate meets our goal of less than 10% missing/unusable data. There were a possible 340 CO assessment data points.
Measured: 3-months post quit date (approximately 4 months after baseline assessment)
Feasibility 3: Participant Attendance
Participants in the PTSC-S intervention will attend at least 60% of their sessions
Measured: 8 weeks of counseling with a 2-week grace period to make up missed sessions (10 weeks)
Secondary outcomes (6)
Number of Participants With Seven-day Point Prevalence Abstinence at End-of-counseling
No smoking on the 7 days before the final counseling session, biochemically verified with CO<8ppm
Measured: End-of-counseling (8 weeks)
Number of Participants With Prolonged Abstinence at End-of-counseling
Prolonged abstinence with a 2-week grace period following the target quit date until end-of-counseling, biochemically verified with CO<8ppm
Measured: End-of-counseling (8 weeks)
Number of Participants With Seven-day Point Prevalence Abstinence at 3-month Follow-up
No smoking on the 7 days before the 3-month follow-up, biochemically verified with CO<8ppm
Measured: 3-months post target quit date (approximately 4 months after baseline assessment)
Number of Participants With Prolonged Abstinence at at 3-month Followup
Prolonged abstinence with a 2-week grace period following the target quit date until 3-months post quit-date, biochemically verified with CO<8ppm
Measured: 3-months post target quit date (approximately 4 months after baseline assessment)
Task Persistence Scores
14-item Thoughts About Smoking Questionnaire (TASQ). Lower scores represent greater task persistence. The total score can range from a minimum of 14 to a maximum of 98.
Measured: 2 months after baseline assessment and 4 months after baseline assessment
Cigarettes Per Day
Hypothesis 3: As compared to baseline, participants will report smoking fewer cigarettes per day at 2- and 4-months post-baseline. Analysis 3: One-tailed, paired sample t-tests will be used to examine decreases in cigarettes smoked per day on the TASQ at each timepoint.
Measured: 2 months after baseline assessment and 4 months after baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start22 Apr 2019
- Primary completion10 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tobacco UseStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Due to the pandemic, this study was modified from a randomized clinical trial to test the feasibility, initial efficacy, and mechanisms of action of our PTSC-S intervention to a feasibility and acceptability test of our intervention when delivered via telehealth in a single group, within-subjects design.
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Marc L. Steinberg, Ph.D., Rutgers, The State University of New Jersey
- Investigators
- Marc L Steinberg, Ph.D., Principal investigator, Rutgers Robert Wood Johnson Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03873337
- Sponsor's protocol ID
- Pro2018001696
- Other IDs
- R33DA041163
- Acronym
- PTSC-S
- Status last verified
- Aug 2022
- First submitted
- 11 Mar 2019
- Last updated
- 13 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Requests for de-identified data from qualified researchers will be considered once the study has been completed.
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persistence Targeted Smoking Cessation in Schizophrenia (PTSC-S)
- ClinicalTrials.gov ID
- NCT03873337
- Acronym / sponsor ID
- PTSC-S / Pro2018001696
- Conditions
- Tobacco Use, Tobacco Smoking, Tobacco Use Cessation, Tobacco Use Disorder, Schizophrenia, Schizoaffective Disorder
- Keywords
- tobacco, cigarette, schizophrenia, schizoaffective disorders, smoking cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 22 Apr 2019 (actual)
- Primary completion
- 10 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 13 Mar 2019 (actual)
- Results
- Posted 16 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Due to the pandemic, this study was modified from a randomized clinical trial to test the feasibility, initial efficacy, and mechanisms of action of our PTSC-S intervention to a feasibility and acceptability test of our intervention when delivered via telehealth in a single group, within-subjects design.
Detailed description
The investigators will test the feasibility and acceptability of a telehealth-delivered treatment designed to help smokers with serious mental illness to quit using a therapy approach focused on increasing task persistence.
We 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. We will report prolonged and point prevalence abstinence rates at end-of-counseling and at 3-month follow-up (CO verified <8ppm).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Due to the pandemic, this study was modified from a randomized clinical trial to test the feasibility, initial efficacy, and mechanisms of action of our PTSC-S intervention to a feasibility and acceptability test of our intervention when delivered via telehealth in a single group, within-subjects design.
| Arm | Type | Receives |
|---|---|---|
| NRT + Persistence Targeted Smoking Cessation in SMI | Experimental | Behavioral: Persistence Targeted Smoking Cessation in SMI (PTSC-S), Drug: Nicotine patchParticipants will receive 10 weeks of nicotine patch (NRT) plus 8 weeks of task persistence focused cessation counseling delivered via telehealth. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
- Must not report myocardial infarction, unstable angina pectoris, or significant cardiac arrhythmia (including atrial fibrillation) in the past 30 days.
- Women must not be pregnant, "test positive" on a pregnancy test, nursing, or planning on becoming pregnant in the next three months. Women who can become pregnant may be included if using effective birth control.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Persistence Targeted Smoking Cessation in SMI (PTSC-S)All participants will receive 8 weeks of persistence focused smoking cessation counseling delivered via telehealth | Behavioural | NRT + Persistence Targeted Smoking Cessation in SMI |
| Nicotine patchAll participants will receive 10 weeks of nicotine patch | Drug | NRT + Persistence Targeted Smoking Cessation in SMI |
Primary outcome
Acceptability 1: Participant Rating of Usefulness of Intervention
Time frame: 3-months post quit date (approximately 4-months after baseline assessment)
After each session, participants (N=33) provided a 1-7 rating of how "easy to understand" and how "helpful" the intervention was. Higher numbers represent greater ease and greater helpfulness, respectfully. There is no official scale title because the scale was developed for this study.
Acceptability 2: Participant Rating of Counseling Session Length
Time frame: 3-months post quit date (approximately 4 months after baseline assessment)
After each session, participants (N=33) provided a 1-7 rating of agreement with the statement, "There was too much information in today's session." (as a proxy for appropriateness of session length). Higher numbers represent greater agreement. There is no official scale title because the scale was developed for this study.
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)
We asked participants how acceptable the placement of the target quit date was to participants (i.e., it was scheduled for session 4). We report the percentage of participants who responded that the quit date was "too soon", "too late", or "just about right".
Feasibility 1: Number of Participants Contacted at 3 Months Post-Quite Date
Time frame: 3-months post quit date (approximately 4 months after baseline assessment)
We will calculate follow-up rates to determine if they meet our goal of 80% follow-up rates at the 3-month follow-up.
Feasibility 2: Missing/Unusable Data
Time frame: 3-months post quit date (approximately 4 months after baseline assessment)
We will determine the rate of missing or unusable carbon monoxide (CO) data to determine if the rate meets our goal of less than 10% missing/unusable data. There were a possible 340 CO assessment data points.
Feasibility 3: Participant Attendance
Time frame: 8 weeks of counseling with a 2-week grace period to make up missed sessions (10 weeks)
Participants in the PTSC-S intervention will attend at least 60% of their sessions
6 secondary outcomes
Number of Participants With Seven-day Point Prevalence Abstinence at End-of-counseling
Time frame: End-of-counseling (8 weeks)
Number of Participants With Prolonged Abstinence at End-of-counseling
Time frame: End-of-counseling (8 weeks)
Number of Participants With Seven-day Point Prevalence Abstinence at 3-month Follow-up
Time frame: 3-months post target quit date (approximately 4 months after baseline assessment)
Number of Participants With Prolonged Abstinence at at 3-month Followup
Time frame: 3-months post target quit date (approximately 4 months after baseline assessment)
Task Persistence Scores
Time frame: 2 months after baseline assessment and 4 months after baseline assessment
Cigarettes Per Day
Time frame: 2 months after baseline assessment and 4 months after baseline assessment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Requests for de-identified data from qualified researchers will be considered once the study has been completed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc L Steinberg, Ph.D. principal investigator
Rutgers Robert Wood Johnson Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Persistence Targeted Smoking Cessation in SMI (PTSC-S) and Nicotine patch in people with Tobacco Use and Tobacco Smoking, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability 1: Participant Rating of Usefulness of Intervention (time frame: 3-months post quit date (approximately 4-months after baseline assessment)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2022.