Opioid Use DisorderPhase 2NCT05722561
E-Cigarettes for Harm Reduction in Smokers With Opioid Use Disorder
A Phase 2 study testing Telehealth Motivational Counseling, Nicotine Replacement Product and National Institute on Drug Abuse (NIDA) Standardized Research Electronic Cigarette (SREC). in people with Opioid Use Disorder and Cigarette Smoking, run by NYU Langone Health at 2 sites in United States.
Trial summary
The purpose of this an open-label, randomized controlled trial study is to compare the effectiveness of electronic cigarettes (e-cigarettes/e-cigs) versus telehealth motivational counseling with combination nicotine replacement therapy (NRT) + telehealth counseling on combustible cigarettes smoking reduction among… Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Opioid Use Disorder, Cigarette Smoking
- What is being tested?
- Telehealth Motivational Counseling, Nicotine Replacement Product and National Institute on Drug Abuse (NIDA) Standardized Research Electronic Cigarette (SREC).
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Aug 2024to 1 Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
Omar El-Shahawy, 646-501-3587, Omar.ElShahawy@nyulangone.org
- Not yet recruiting
Albert Einstein College of Medicine
The Bronx, New York, 10461
Shadi Nahvi, MD
About this study
Official title: Effectiveness and Impact of Counseling Enhanced With Electronic Cigarettes for Harm Reduction in Smokers With Opioid Use Disorder
The purpose of this an open-label, randomized controlled trial study is to compare the effectiveness of electronic cigarettes (e-cigarettes/e-cigs) versus 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.
- Conditions
- Opioid Use Disorder, Cigarette Smoking
- Being tested
- Telehealth Motivational Counseling, Nicotine Replacement Product, National Institute on Drug Abuse (NIDA) Standardized Research Electronic Cigarette (SREC).
- Keywords
- cigarettes, smoking, smoking reduction, OUD, OUDTP, Buprenorphine, Methadone
- Medical subject headings
- Opioid-Related Disorders, Cigarette Smoking, Smoking, Smoking Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telehealth Motivational CounselingBehavioural
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, 6), 15~20 minutes each.
Nicotine Replacement ProductDrug
Combination nicotine replacement therapy with lozenges and patches. Participants are recommended to use the NRT according to product directions.
National Institute on Drug Abuse (NIDA) Standardized Research Electronic Cigarette (SREC).Device
Participants are to use the electronic cigarette freely as replacement for smoking combustible cigarettes.
| Study group | Role | What they receive |
|---|---|---|
| Electronic Cigarette | Experimental | Participants in the Electronic Cigarette (EC) arm will receive telehealth motivational counseling for 5 weeks plus the standardized research e-cigarette (SREC). Receives: Behavioral: Telehealth Motivational Counseling; Device: National Institute on Drug Abuse (NIDA) Standardized Research Electronic Cigarette (SREC). |
| Nicotine Replacement Therapy | Active comparator | Participants in the Nicotine Replacement Therapy (NRT) arm will receive telehealth motivational counseling plus combination NRT (patch and lozenge). Receives: Behavioral: Telehealth Motivational Counseling; Drug: Nicotine Replacement Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to Visit 5 (Day 56)
Secondary outcomes (9)
Percentage of Participants who Achieve 100% Reduction in CPD between Baseline and Month 6 Follow-Up
Verified by exhaled carbon-monoxide (eCO) level.
Measured: Month 6
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.
Measured: From Visit 5 (Day 56) up to Month 6
Change from Baseline in Self-Reported CPD at End of Intervention (Visit 5)
Verified by exhaled carbon-monoxide (eCO) level.
Measured: Baseline, Visit 5 (Day 56)
Change from Baseline in Self-Reported CPD at Month 6
Verified by exhaled carbon-monoxide (eCO) level.
Measured: Baseline, Month 6
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.
Measured: Baseline, Visit 5 (Day 56)
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.
Measured: Baseline, Month 6
Number of Respiratory Symptoms Reported at Baseline
Measured: Baseline
Number of Respiratory Symptoms Reported at End of Treatment (Visit 5)
Measured: Visit 5 (Day 56)
Number of Respiratory Symptoms Reported at Month 6 Follow-up
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start8 Aug 2024
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 302 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Omar El-Shahawy, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05722561
- Sponsor's protocol ID
- 22-00661
- Status last verified
- Mar 2026
- First submitted
- 1 Feb 2023
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Impact of Counseling Enhanced With Electronic Cigarettes for Harm Reduction in Smokers With Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT05722561
- Acronym / sponsor ID
- 22-00661
- Conditions
- Opioid Use Disorder, Cigarette Smoking
- Keywords
- cigarettes, smoking, smoking reduction, OUD, OUDTP, Buprenorphine, Methadone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 302 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 8 Aug 2024 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 10 Feb 2023 (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 purpose of this an open-label, randomized controlled trial study is to compare the effectiveness of electronic cigarettes (e-cigarettes/e-cigs) versus 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electronic Cigarette | Experimental | Behavioral: Telehealth Motivational Counseling, Device: National Institute on Drug Abuse (NIDA) Standardized Research Electronic Cigarette (SREC).Participants in the Electronic Cigarette (EC) arm will receive telehealth motivational counseling for 5 weeks plus the standardized research e-cigarette (SREC). |
| Nicotine Replacement Therapy | Active comparator | Behavioral: Telehealth Motivational Counseling, Drug: Nicotine Replacement ProductParticipants in the Nicotine Replacement Therapy (NRT) arm will receive telehealth motivational counseling plus combination NRT (patch and lozenge). |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Telehealth Motivational CounselingAt 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, 6), 15~20 minutes each. | Behavioural | Electronic Cigarette, Nicotine Replacement Therapy |
| Nicotine Replacement ProductCombination nicotine replacement therapy with lozenges and patches. Participants are recommended to use the NRT according to product directions. | Drug | Nicotine Replacement Therapy |
| National Institute on Drug Abuse (NIDA) Standardized Research Electronic Cigarette (SREC).Participants are to use the electronic cigarette freely as replacement for smoking combustible cigarettes. | Device | Electronic Cigarette |
Primary outcome
Percentage of Participants who Achieve 100% Reduction in Cigarettes Per Day (CPD) between Baseline and End of Intervention (Visit 5)
Time frame: Up to Visit 5 (Day 56)
Verified by exhaled carbon-monoxide (eCO) level.
9 secondary outcomes
Percentage of Participants who Achieve 100% Reduction in CPD between Baseline and Month 6 Follow-Up
Time frame: Month 6
Percentage of Participants who Achieve 100% Reduction in CPD between End of Intervention (Visit 5) and Month 6 Follow-Up
Time frame: From Visit 5 (Day 56) up to Month 6
Change from Baseline in Self-Reported CPD at End of Intervention (Visit 5)
Time frame: Baseline, Visit 5 (Day 56)
Change from Baseline in Self-Reported CPD at Month 6
Time frame: Baseline, Month 6
Change from Baseline in Health-Related Quality of Life (HRQOL) Survey Score at End of Intervention (Visit 5)
Time frame: Baseline, Visit 5 (Day 56)
Change from Baseline in Health-Related Quality of Life (HRQOL) Survey Score at Month 6 Follow-up
Time frame: Baseline, Month 6
Number of Respiratory Symptoms Reported at Baseline
Time frame: Baseline
Number of Respiratory Symptoms Reported at End of Treatment (Visit 5)
Time frame: Visit 5 (Day 56)
Number of Respiratory Symptoms Reported at Month 6 Follow-up
Time frame: Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: Yes. 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.
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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.
Omar El-Shahawy principal investigator
NYU Langone Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Telehealth Motivational Counseling, Nicotine Replacement Product and National Institute on Drug Abuse (NIDA) Standardized Research Electronic Cigarette (SREC). in people with Opioid Use Disorder and Cigarette Smoking, run by NYU Langone Health at 2 sites 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 7 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: looking for participants now, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Omar El-Shahawy, MD, MPH, PhD (646-501-3587, Omar.ElShahawy@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants who Achieve 100% Reduction in Cigarettes Per Day (CPD) between Baseline and End of Intervention (Visit 5) (time frame: Up to Visit 5 (Day 56)). 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 11 Mar 2026.