Smoking CessationNCT03346291
Examining Persistence in Smokers With Schizophrenia
A study testing counseling in people with Smoking Cessation and Schizophrenia, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
All participants will receive free weekly counseling (8- weeks) and free nicotine patches (10-weeks). They will complete assessment measures commonly used in smoking cessation studies. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Smoking Cessation, Schizophrenia, Schizo Affective Disorder
- What is being tested?
- counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to 13 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Must be between 18 - 64 years old
- Must indicate commitment to quitting smoking in the next 30 days
- Must smoke at least 5 cigarettes per day for past 6-months
- Expired breath carbon monoxide (CO) > 5 to ensure daily cigarette use
- Must score < 8 (or <7 for women) on the Alcohol Use Disorders Identification Test
- Must score less than 3 on the 6-month Drug Abuse Screening Test-10
Show all 11Show fewer
- Must provide a negative urine drug screen for cannabis, cocaine, opiates, or
- methamphetamine (Note: Participants with a positive screen for opiates may
- participate with proof of prescription for opiates.)
- Must have a diagnosis of Schizophrenia or Schizoaffective Disorder on Structured Clinical Interview
- Psychiatric illness must be stable, as indicated by no hospitalizations in previous 8 weeks, and a stable psychotropic medication regimen including a stable antipsychotic dose for 8 weeks
Who cannot join
- Must not be currently receiving tobacco dependence treatment counseling
- Must not currently be taking varenicline (Chantix)
- Must not 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 unstable angina pectoris, myocardial infarction, or significant cardiac arrhythmia (including atrial fibrillation) in the past 90 days
- Must not be pregnant, breastfeeding, or planning on becoming pregnant in the next 4-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
- Must not be planning on moving outside local area in next 3-months
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgers Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
About this study
All participants will receive free weekly counseling (8- weeks) and free nicotine patches (10-weeks). They will complete assessment measures commonly used in smoking cessation studies. We hope to show that this treatment is feasible in this small pilot study before comparing it to a more established treatment in a future randomized clinical trial.
Read the detailed description
This study is a non-randomized trial of a new psychosocial treatment for smoking cessation (for smokers with schizophrenia) that is based on cognitive behavioral therapy for smoking cessation - a commonly used approach. Participants will receive free weekly counseling (8- weeks) and free nicotine patches (10-weeks). They will complete assessment measures commonly used in smoking cessation studies. We hope to show that this treatment is feasible in this small pilot study before comparing it to a more established treatment in a future randomized clinical trial.
- Conditions
- Smoking Cessation, Schizophrenia, Schizo Affective Disorder
- Being tested
- counseling
- Medical subject headings
- Smoking Cessation, Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
counselingBehavioural
individual, weekly, smoking cessation counseling + over-the-counter nicotine patch
| Study group | Role | What they receive |
|---|---|---|
| Persistence Targeted Smoking Cessation | Experimental | 8 weekly counseling sessions + 10 weeks of over-the-counter nicotine patch Receives: Behavioral: counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Task Persistence - Mirror Tracing
Number of seconds persisting on a computerized mirror tracing task (Higher number of seconds = greater persistence)
Measured: Through end-of-treatment - approximately 8 weeks after baseline
Task Persistence - Sustained Divided Attention Task
Seconds persisting on Sustained Divided Attention Task (Higher number of seconds = greater persistence)
Measured: Through end-of-treatment - approximately 8 weeks after baseline
Task Persistence - Breath-holding
Number of seconds persisting on a breath-holding endurance task (Higher number of seconds = greater persistence)
Measured: Through end-of-treatment - approximately 8 weeks after baseline
Task Persistence -Temperament and Character Inventory-Persistence Scale (TCI-P)
Score on Temperament and Character Inventory-Persistence Scale (TCI-P) (Higher score = greater persistence)
Measured: Through end-of-treatment - approximately 8 weeks after baseline
Task Persistence - 2-item Task Persistence Measure
Score on 2-item Task Persistence Measure (Higher score = greater persistence)
Measured: Through end-of-treatment - approximately 8 weeks after baseline
Task Persistence - Distress Tolerance Scale (DTS)
Score on Distress Tolerance Scale (DTS) (Higher score = greater persistence)
Measured: Through end-of-treatment - approximately 8 weeks after baseline
Task Persistence - Thoughts About Smoking Questionnaire
Score on the Thoughts About Smoking Questionnaire (Higher score = less persistence)
Measured: Through end-of-treatment - approximately 8 weeks after baseline
Self-reported ratings of ease of understanding and helpfulness of counseling
percentage of participants who rate the intervention as "easy to understand" and "helpful"
Measured: Through end-of-treatment - approximately 8 weeks after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study startJan 2017
- Primary completion13 Jun 2018
- Study completion13 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 27 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, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03346291
- Sponsor's protocol ID
- 20150001885
- Other IDs
- R21DA041163-01
- Status last verified
- Jan 2019
- First submitted
- 3 Nov 2017
- Last updated
- 17 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Persistence in Smokers With Schizophrenia
- ClinicalTrials.gov ID
- NCT03346291
- Acronym / sponsor ID
- 20150001885
- Conditions
- Smoking Cessation, Schizophrenia, Schizo Affective Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jan 2017 (actual)
- Primary completion
- 13 Jun 2018 (actual)
- Study completion
- 13 Jun 2018 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
All participants will receive free weekly counseling (8- weeks) and free nicotine patches (10-weeks). They will complete assessment measures commonly used in smoking cessation studies. We hope to show that this treatment is feasible in this small pilot study before comparing it to a more established treatment in a future randomized clinical trial.
Detailed description
This study is a non-randomized trial of a new psychosocial treatment for smoking cessation (for smokers with schizophrenia) that is based on cognitive behavioral therapy for smoking cessation - a commonly used approach. Participants will receive free weekly counseling (8- weeks) and free nicotine patches (10-weeks). They will complete assessment measures commonly used in smoking cessation studies. We hope to show that this treatment is feasible in this small pilot study before comparing it to a more established treatment in a future randomized clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Persistence Targeted Smoking Cessation | Experimental | Behavioral: counseling8 weekly counseling sessions + 10 weeks of over-the-counter nicotine patch |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Must be between 18 - 64 years old
- Must indicate commitment to quitting smoking in the next 30 days
- Must smoke at least 5 cigarettes per day for past 6-months
- Expired breath carbon monoxide (CO) > 5 to ensure daily cigarette use
- Must score < 8 (or <7 for women) on the Alcohol Use Disorders Identification Test
Key exclusion criteria (8 listed)
- Must not be currently receiving tobacco dependence treatment counseling
- Must not currently be taking varenicline (Chantix)
- Must not 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 unstable angina pectoris, myocardial infarction, or significant cardiac arrhythmia (including atrial fibrillation) in the past 90 days
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 |
|---|---|---|
| counselingindividual, weekly, smoking cessation counseling + over-the-counter nicotine patch | Behavioural | Persistence Targeted Smoking Cessation |
Primary outcome
Task Persistence - Mirror Tracing
Time frame: Through end-of-treatment - approximately 8 weeks after baseline
Number of seconds persisting on a computerized mirror tracing task (Higher number of seconds = greater persistence)
Task Persistence - Sustained Divided Attention Task
Time frame: Through end-of-treatment - approximately 8 weeks after baseline
Seconds persisting on Sustained Divided Attention Task (Higher number of seconds = greater persistence)
Task Persistence - Breath-holding
Time frame: Through end-of-treatment - approximately 8 weeks after baseline
Number of seconds persisting on a breath-holding endurance task (Higher number of seconds = greater persistence)
Task Persistence -Temperament and Character Inventory-Persistence Scale (TCI-P)
Time frame: Through end-of-treatment - approximately 8 weeks after baseline
Score on Temperament and Character Inventory-Persistence Scale (TCI-P) (Higher score = greater persistence)
Task Persistence - 2-item Task Persistence Measure
Time frame: Through end-of-treatment - approximately 8 weeks after baseline
Score on 2-item Task Persistence Measure (Higher score = greater persistence)
Task Persistence - Distress Tolerance Scale (DTS)
Time frame: Through end-of-treatment - approximately 8 weeks after baseline
Score on Distress Tolerance Scale (DTS) (Higher score = greater persistence)
Task Persistence - Thoughts About Smoking Questionnaire
Time frame: Through end-of-treatment - approximately 8 weeks after baseline
Score on the Thoughts About Smoking Questionnaire (Higher score = less persistence)
Self-reported ratings of ease of understanding and helpfulness of counseling
Time frame: Through end-of-treatment - approximately 8 weeks after baseline
percentage of participants who rate the intervention as "easy to understand" and "helpful"
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2019.
- Individual participant dataSharing planned: No
Related trials for Smoking Cessation
Recruiting
Smoking Cessation in Patients With Cancer
Cancer, Tobacco Use
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruiting
Effectiveness Of Project EX: A Classroom-Based Smoking Prevention And Cessation Intervention Program
Focus of the Study is Smoking Cessation and Prevention, Smoking Prevention
RecruitingObservational study
Collection of Airway, Blood and/or Urine Specimens From Subjects for Research Studies
Chronic Obstructive Pulmonary Disease (COPD), Smoking
Recruiting
Therapeutic Contact Intensity in a Psychological Smoking Cessation Intervention With an App
Smoking Behaviors
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, The State University of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing counseling in people with Smoking Cessation and Schizophrenia, 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 11 inclusion and 8 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 17 Jan 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Task Persistence - Mirror Tracing (time frame: Through end-of-treatment - approximately 8 weeks after baseline). The study lists 8 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 17 Jan 2019.