Tobacco UseNCT04334187
NYCHA Mindfulness-based Smoking Cessation Intervention
A study testing Mindfulness Based addition treatment in people with Tobacco Use, run by NYU Langone Health.
Trial summary
The study will assess feasibility, accessibility and impact of a mindfulness-based smoking cessation group intervention for New York City Housing Authority (NYCHA) residents. Residents who smoke to receive an 8-week intervention. Participants will also be offered 4 weeks of nicotine replacement therapy (NRT). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Tobacco Use
- What is being tested?
- Mindfulness Based addition treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2021to Dec 2021
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Current smoker (>= 5 cigarettes per day). Dual tobacco users are eligible as long as their primary tobacco product is cigarettes.
- Ready to quit smoking cigarettes within 30 days
- Able to attend the 8 weekly MBAT sessions at the scheduled days/times
- NYCHA resident
- English language
- Able to provide informed consent
Who cannot join
- Pregnant or breastfeeding
- Patient Health Questionnaire-2 (PHQ-2) score indicating current risk for depression
- Self-reported diagnosis of schizophrenia, bipolar disorder, schizotypal disorder or other psychotic disorder
About this study
Official title: Feasibility and Accessibility of a Mindfulness-based Smoking Cessation Intervention for NYCHA Residents
The study will assess feasibility, accessibility and impact of a mindfulness-based smoking cessation group intervention for New York City Housing Authority (NYCHA) residents. Residents who smoke to receive an 8-week intervention. Participants will also be offered 4 weeks of nicotine replacement therapy (NRT).
Read the detailed description
The primary objective of this research is to examine the feasibility, accessibility and impact of a mindfulness-based smoking cessation program for NYCHA residents.
- Conditions
- Tobacco Use
- Being tested
- Mindfulness Based addition treatment
- Medical subject headings
- Tobacco Use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based addition treatmentBehavioural
The intervention is comprised of 8 weekly group MBAT sessions. Two weekly groups of about 10 participants each will be conducted. All participants will also have the option to receive nicotine patches, gum, or lozenges for four weeks as part of their time in the study. Participants will complete surveys at enrollment (baseline), immediately after their last MBAT session (around 2 months after enrollment) and one month after completing treatment (3 months post-enrollment). Surveys will assess primary and secondary outcomes and satisfaction with the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Smoke Cessation Group | Experimental | Mindfulness-based smoking cessation sessions will follow the mindfulness based addiction treatment (MBAT) intervention for smoking cessation. Sessions are in group format for two hours, weekly. Two groups of sessions with about 10 participants per group will be organized. Receives: Behavioral: Mindfulness Based addition treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who perceive the Mindfulness based addiction treatment as useful at time of Enrollment
Participants will report their perceived usefulness and effectiveness of the intervention using self reported surveys at enrollment (baseline).
Measured: Baseline
Number of participants who perceive the Mindfulness based addiction treatment as useful after last MBAT session.
Number of participants will report their perceived usefulness and effectiveness of the intervention using self reported surveys after their last MBAT session (2 months after enrollment).
Measured: 2 months
Number of participants who perceive the Mindfulness based addiction treatment as useful post treatment
Participants will report their perceived usefulness and effectiveness of the intervention using self reported surveys one month after completing treatment (3 months post-enrollment).
Measured: 3 months
Number of participants who perceive the Mindfulness based addiction treatment as effective
Participants who self-report 7-day abstinence in the final follow up survey (3 months) will provide a biochemically validated saliva sample
Measured: 3 months
Secondary outcomes (2)
Number of participants who adhered to the Mindfulness based addiction treatment
This will be reported in the number of sessions attended and completed mindfulness exercises in between the sessions.
Measured: 3 months
Number of participants who self reported abstinence
This will be self reported at the end of the treatment (2 months)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study startJun 2021 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Why it stopped: Due to the pandemic's impacts on being able to conduct the intervention for this study, unable to begin recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco UseStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erin Rogers, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04334187
- Sponsor's protocol ID
- 19-01435
- Status last verified
- Feb 2022
- First submitted
- 26 Mar 2020
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Accessibility of a Mindfulness-based Smoking Cessation Intervention for NYCHA Residents
- ClinicalTrials.gov ID
- NCT04334187
- Acronym / sponsor ID
- 19-01435
- Conditions
- Tobacco Use
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to the pandemic's impacts on being able to conduct the intervention for this study, unable to begin recruitment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Jun 2021 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 6 Apr 2020 (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.
The study will assess feasibility, accessibility and impact of a mindfulness-based smoking cessation group intervention for New York City Housing Authority (NYCHA) residents. Residents who smoke to receive an 8-week intervention. Participants will also be offered 4 weeks of nicotine replacement therapy (NRT).
Detailed description
The primary objective of this research is to examine the feasibility, accessibility and impact of a mindfulness-based smoking cessation program for NYCHA residents.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Smoke Cessation Group | Experimental | Behavioral: Mindfulness Based addition treatmentMindfulness-based smoking cessation sessions will follow the mindfulness based addiction treatment (MBAT) intervention for smoking cessation. Sessions are in group format for two hours, weekly. Two groups of sessions with about 10 participants per group will be organized. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18 years
- Current smoker (>= 5 cigarettes per day). Dual tobacco users are eligible as long as their primary tobacco product is cigarettes.
- Ready to quit smoking cigarettes within 30 days
- Able to attend the 8 weekly MBAT sessions at the scheduled days/times
- NYCHA resident
Key exclusion criteria (3 listed)
- Pregnant or breastfeeding
- Patient Health Questionnaire-2 (PHQ-2) score indicating current risk for depression
- Self-reported diagnosis of schizophrenia, bipolar disorder, schizotypal disorder or other psychotic disorder
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 |
|---|---|---|
| Mindfulness Based addition treatmentThe intervention is comprised of 8 weekly group MBAT sessions. Two weekly groups of about 10 participants each will be conducted. All participants will also have the option to receive nicotine patches, gum, or lozenges for four weeks as part of their time in the study. Participants will complete surveys at enrollment (baseline), immediately after their last MBAT session (around 2 months after enrollment) and one month after completing treatment (3 months post-enrollment). Surveys will assess primary and secondary outcomes and satisfaction with the intervention. | Behavioural | Smoke Cessation Group |
Primary outcome
Number of participants who perceive the Mindfulness based addiction treatment as useful at time of Enrollment
Time frame: Baseline
Participants will report their perceived usefulness and effectiveness of the intervention using self reported surveys at enrollment (baseline).
Number of participants who perceive the Mindfulness based addiction treatment as useful after last MBAT session.
Time frame: 2 months
Number of participants will report their perceived usefulness and effectiveness of the intervention using self reported surveys after their last MBAT session (2 months after enrollment).
Number of participants who perceive the Mindfulness based addiction treatment as useful post treatment
Time frame: 3 months
Participants will report their perceived usefulness and effectiveness of the intervention using self reported surveys one month after completing treatment (3 months post-enrollment).
Number of participants who perceive the Mindfulness based addiction treatment as effective
Time frame: 3 months
Participants who self-report 7-day abstinence in the final follow up survey (3 months) will provide a biochemically validated saliva sample
2 secondary outcomes
Number of participants who adhered to the Mindfulness based addiction treatment
Time frame: 3 months
Number of participants who self reported abstinence
Time frame: 2 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices)
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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.
Erin Rogers principal investigator
NYU Langone Health
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Based addition treatment in people with Tobacco Use, run by NYU Langone Health.
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 7 inclusion and 3 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: withdrawn, as of the sponsor's last update on 2 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Number of participants who perceive the Mindfulness based addiction treatment as useful at time of Enrollment (time frame: Baseline). The study lists 4 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 2 Mar 2022.