Back to resultsE-Cigarettes for Harm Reduction in Smokers With Opioid Use Disorder
Primary Purpose
Opioid Use Disorder, Cigarette Smoking
Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Telehealth Motivational Counseling
Nicotine Replacement Product
National Institute on Drug Abuse (NIDA) Standardized Research Electronic Cigarette (SREC).
Sponsored by
About this trial
This is an interventional treatment trial for Opioid Use Disorder focused on measuring cigarettes, smoking, smoking reduction, OUD, OUDTP, Buprenorphine, Methadone
Eligibility Criteria
Inclusion Criteria: Currently smokes 5 or more CPD Age ≥ 21 years Has a diagnosis of Opioid Use Disorder In OUDTP (buprenorphine or methadone) ≥ 12 weeks via self-report or EHR records Stable methadone or buprenorphine dose for two weeks via self-report or EHR records Interested in reducing combustible cigarette (CC) smoking but not necessarily trying to quit Own a mobile phone or have regular access to a mobile phone. Able to provide an additional contact to improve follow-up rates. Exclusion Criteria: Does not speak English or Spanish Are pregnant or breastfeeding Not able to provide consent Used tobacco products other than CC in the past 2 weeks (e.g., EC, cigarillo) Currently engaged in an attempt to quit CC smoking Reports having severe chronic obstructive pulmonary disease or asthma (i.e., with exacerbation requiring hospitalization or intubation in the prior 6 months) Reports current major depressive or manic episode, current psychotic disorder, past-year suicide attempt or psychiatric hospitalization, or current suicidal ideation with plan or intent.
Sites / Locations
- NYU Langone Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Electronic Cigarette
Nicotine Replacement Therapy
Arm Description
Participants in the Electronic Cigarette (EC) arm will receive telehealth motivational counseling for 6 weeks plus the standardized research e-cigarette (SREC).
Participants in the Nicotine Replacement Therapy (NRT) arm will receive telehealth motivational counseling plus combination NRT (patch and lozenge).
Outcomes
Primary Outcome Measures
Percentage of Participants who Achieve 100% Reduction in Cigarettes Per Day (CPD) between Baseline and End of Intervention (Visit 5)
Verified by exhaled carbon-monoxide (eCO) level.
Secondary Outcome Measures
Percentage of Participants who Achieve 100% Reduction in CPD between Baseline and Month 6 Follow-Up
Verified by exhaled carbon-monoxide (eCO) level.
Percentage of Participants who Achieve 100% Reduction in CPD between End of Intervention (Visit 5) and Month 6 Follow-Up
Verified by exhaled carbon-monoxide (eCO) level.
Change from Baseline in Self-Reported CPD at End of Intervention (Visit 5)
Verified by exhaled carbon-monoxide (eCO) level.
Change from Baseline in Self-Reported CPD at Month 6
Verified by exhaled carbon-monoxide (eCO) level.
Change from Baseline in Health-Related Quality of Life (HRQOL) Survey Score at End of Intervention (Visit 5)
8-item self assessment of participants' perceived physical and mental health over time. Each item lists a condition. For each item, participants indicate the number of days the condition applied to them. The total score is the average of responses and ranges from 0-30. Lower scores indicate greater perceived physical and mental health. A reduction in scores indicates perceived physical and mental health improved over the observational period.
Change from Baseline in Health-Related Quality of Life (HRQOL) Survey Score at Month 6 Follow-up
8-item self assessment of participants' perceived physical and mental health over time. Each item lists a condition. For each item, participants indicate the number of days the condition applied to them. The total score is the average of responses and ranges from 0-30. Lower scores indicate greater perceived physical and mental health. A reduction in scores indicates perceived physical and mental health improved over the observational period.
Number of Respiratory Symptoms Reported at Baseline
Number of Respiratory Symptoms Reported at End of Treatment (Visit 5)
Number of Respiratory Symptoms Reported at Month 6 Follow-up
Full Information
NCT ID
NCT05722561
First Posted
February 1, 2023
Last Updated
July 13, 2023
Sponsor
NYU Langone Health
Collaborators
National Institutes of Health (NIH)
1. Study Identification
Unique Protocol Identification Number
NCT05722561
Brief Title
E-Cigarettes for Harm Reduction in Smokers With Opioid Use Disorder
Official Title
Effectiveness and Impact of Counseling Enhanced With Electronic Cigarettes for Harm Reduction in Smokers With Opioid Use Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 30, 2023 (Anticipated)
Primary Completion Date
January 30, 2025 (Anticipated)
Study Completion Date
May 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Institutes of Health (NIH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this an open-label, randomized controlled trial study is to compare the effectiveness of electronic cigarettes (e-cigarettes/e-cigs) with telehealth motivational counseling with combination nicotine replacement therapy (NRT) + telehealth counseling on combustible cigarettes smoking reduction among persons with opioid use disorder (OUD) in methadone and buprenorphine treatment programs (opioid use disorder treatment programs (OUDTP)). OUDTP patients are a population with exceptionally high combustible cigarettes smoking burden and yet limited success in achieving meaningful clinical outcomes in tobacco treatment. If effective, electronic cigarettes would provide an additional tool for tobacco harm reduction among this difficult-to-treat vulnerable population.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use Disorder, Cigarette Smoking
Keywords
cigarettes, smoking, smoking reduction, OUD, OUDTP, Buprenorphine, Methadone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
350 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Electronic Cigarette
Arm Type
Experimental
Arm Description
Participants in the Electronic Cigarette (EC) arm will receive telehealth motivational counseling for 6 weeks plus the standardized research e-cigarette (SREC).
Arm Title
Nicotine Replacement Therapy
Arm Type
Active Comparator
Arm Description
Participants in the Nicotine Replacement Therapy (NRT) arm will receive telehealth motivational counseling plus combination NRT (patch and lozenge).
Intervention Type
Behavioral
Intervention Name(s)
Telehealth Motivational Counseling
Intervention Description
At baseline, after randomization, participants will receive their first telehealth session (20~25 minutes) from a counselor trained in motivational interviewing, harm reduction, and smoking cessation. Four additional sessions will be delivered (weeks 2, 3, 4, and 6), 15~20 minutes each.
Intervention Type
Drug
Intervention Name(s)
Nicotine Replacement Product
Intervention Description
Combination nicotine replacement therapy with lozenges and patches. Participants are recommended to use the NRT according to product directions.
Intervention Type
Device
Intervention Name(s)
National Institute on Drug Abuse (NIDA) Standardized Research Electronic Cigarette (SREC).
Intervention Description
Participants are to use the electronic cigarette freely as replacement for smoking combustible cigarettes.
Primary Outcome Measure Information:
Title
Percentage of Participants who Achieve 100% Reduction in Cigarettes Per Day (CPD) between Baseline and End of Intervention (Visit 5)
Description
Verified by exhaled carbon-monoxide (eCO) level.
Time Frame
Up to Visit 5 (Day 56)
Secondary Outcome Measure Information:
Title
Percentage of Participants who Achieve 100% Reduction in CPD between Baseline and Month 6 Follow-Up
Description
Verified by exhaled carbon-monoxide (eCO) level.
Time Frame
Month 6
Title
Percentage of Participants who Achieve 100% Reduction in CPD between End of Intervention (Visit 5) and Month 6 Follow-Up
Description
Verified by exhaled carbon-monoxide (eCO) level.
Time Frame
From Visit 5 (Day 56) up to Month 6
Title
Change from Baseline in Self-Reported CPD at End of Intervention (Visit 5)
Description
Verified by exhaled carbon-monoxide (eCO) level.
Time Frame
Baseline, Visit 5 (Day 56)
Title
Change from Baseline in Self-Reported CPD at Month 6
Description
Verified by exhaled carbon-monoxide (eCO) level.
Time Frame
Baseline, Month 6
Title
Change from Baseline in Health-Related Quality of Life (HRQOL) Survey Score at End of Intervention (Visit 5)
Description
8-item self assessment of participants' perceived physical and mental health over time. Each item lists a condition. For each item, participants indicate the number of days the condition applied to them. The total score is the average of responses and ranges from 0-30. Lower scores indicate greater perceived physical and mental health. A reduction in scores indicates perceived physical and mental health improved over the observational period.
Time Frame
Baseline, Visit 5 (Day 56)
Title
Change from Baseline in Health-Related Quality of Life (HRQOL) Survey Score at Month 6 Follow-up
Description
8-item self assessment of participants' perceived physical and mental health over time. Each item lists a condition. For each item, participants indicate the number of days the condition applied to them. The total score is the average of responses and ranges from 0-30. Lower scores indicate greater perceived physical and mental health. A reduction in scores indicates perceived physical and mental health improved over the observational period.
Time Frame
Baseline, Month 6
Title
Number of Respiratory Symptoms Reported at Baseline
Time Frame
Baseline
Title
Number of Respiratory Symptoms Reported at End of Treatment (Visit 5)
Time Frame
Visit 5 (Day 56)
Title
Number of Respiratory Symptoms Reported at Month 6 Follow-up
Time Frame
Month 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Currently smokes 5 or more CPD
Age ≥ 21 years
Has a diagnosis of Opioid Use Disorder
In OUDTP (buprenorphine or methadone) ≥ 12 weeks via self-report or EHR records
Stable methadone or buprenorphine dose for two weeks via self-report or EHR records
Interested in reducing combustible cigarette (CC) smoking but not necessarily trying to quit
Own a mobile phone or have regular access to a mobile phone.
Able to provide an additional contact to improve follow-up rates.
Exclusion Criteria:
Does not speak English or Spanish
Are pregnant or breastfeeding
Not able to provide consent
Used tobacco products other than CC in the past 2 weeks (e.g., EC, cigarillo)
Currently engaged in an attempt to quit CC smoking
Reports having severe chronic obstructive pulmonary disease or asthma (i.e., with exacerbation requiring hospitalization or intubation in the prior 6 months)
Reports current major depressive or manic episode, current psychotic disorder, past-year suicide attempt or psychiatric hospitalization, or current suicidal ideation with plan or intent.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Omar El-Shahawy
Phone
646-501-3587
Email
Omar.ElShahawy@nyulangone.org
First Name & Middle Initial & Last Name or Official Title & Degree
Kaitlyn Gee
Phone
646-501-3571
Email
Kaitlyn.Gee@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Omar El-Shahawy
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Omar El-Shahawy
Phone
646-501-3587
Email
Omar.ElShahawy@nyulangone.org
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: [Omar.ElShahawy@nyulangone.org]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD Sharing Access Criteria
The investigator who proposed to use the data and researchers who provide a methodologically sound proposal will be granted access to the data upon reasonable request. Requests should be directed to Omar.ElShahawy@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
Learn more about this trial
E-Cigarettes for Harm Reduction in Smokers With Opioid Use Disorder
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