E-Cigarettes for Harm Reduction in Smokers With Opioid Use Disorder

Opioid Use Disorder Clinical Trial

Official title:

Effectiveness and Impact of Counseling Enhanced With Electronic Cigarettes for Harm Reduction in Smokers With Opioid Use Disorder

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05722561
• Other study ID #: 22-00661
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: March 2024
• Est. completion date: March 2027

Study information

• Verified date: January 2024
• Source: NYU Langone Health
• Contact: Omar El-Shahawy
• Phone: 646-501-3587
• Email: Omar.ElShahawy[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 350
• Est. completion date: March 2027
• Est. primary completion date: November 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Currently smokes 5 or more CPD

2. Age = 21 years

3. Has a diagnosis of Opioid Use Disorder

4. In OUDTP (buprenorphine or methadone) = 12 weeks via self-report or EHR records

5. Stable methadone or buprenorphine dose for two weeks via self-report or EHR records

6. Interested in reducing combustible cigarette (CC) smoking but not necessarily trying to quit

7. Own a mobile phone or have regular access to a mobile phone.

8. Able to provide an additional contact to improve follow-up rates.

Exclusion Criteria:

1. Does not speak English or Spanish

2. Are pregnant or breastfeeding

3. Not able to provide consent

4. Used tobacco products other than CC in the past 2 weeks (e.g., EC, cigarillo)

5. Currently engaged in an attempt to quit CC smoking

6. Reports having severe chronic obstructive pulmonary disease or asthma (i.e., with exacerbation requiring hospitalization or intubation in the prior 6 months)

7. 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.

Related Conditions & MeSH terms

• Cigarette Smoking
• Opioid Use Disorder
• Opioid-Related Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• Telehealth Motivational Counseling
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.

Drug:
• Nicotine Replacement Product
Combination nicotine replacement therapy with lozenges and patches. Participants are recommended to use the NRT according to product directions.

Device:
• 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.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up to Visit 5 (Day 56)
Secondary	Percentage of Participants who Achieve 100% Reduction in CPD between Baseline and Month 6 Follow-Up	Verified by exhaled carbon-monoxide (eCO) level.	Month 6
Secondary	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.	From Visit 5 (Day 56) up to Month 6
Secondary	Change from Baseline in Self-Reported CPD at End of Intervention (Visit 5)	Verified by exhaled carbon-monoxide (eCO) level.	Baseline, Visit 5 (Day 56)
Secondary	Change from Baseline in Self-Reported CPD at Month 6	Verified by exhaled carbon-monoxide (eCO) level.	Baseline, Month 6
Secondary	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.	Baseline, Visit 5 (Day 56)
Secondary	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.	Baseline, Month 6
Secondary	Number of Respiratory Symptoms Reported at Baseline		Baseline
Secondary	Number of Respiratory Symptoms Reported at End of Treatment (Visit 5)		Visit 5 (Day 56)
Secondary	Number of Respiratory Symptoms Reported at Month 6 Follow-up		Month 6