Cigarette Smoking, Opioid Use Disorder
Conditions
Keywords
cigarettes, smoking, smoking reduction, OUD, OUDTP, Buprenorphine, Methadone
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) 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.
Interventions
BEHAVIORALTelehealth 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.
Combination nicotine replacement therapy with lozenges and patches. Participants are recommended to use the NRT according to product directions.
DEVICENational Institute on Drug Abuse (NIDA) Standardized Research Electronic Cigarette (SREC).
Participants are to use the electronic cigarette freely as replacement for smoking combustible cigarettes.
Sponsors
NYU Langone Health
National Institutes of Health (NIH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants who Achieve 100% Reduction in Cigarettes Per Day (CPD) between Baseline and End of Intervention (Visit 5) | Up to Visit 5 (Day 56) | Verified by exhaled carbon-monoxide (eCO) level. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Self-Reported CPD at Month 6 | Baseline, Month 6 | Verified by exhaled carbon-monoxide (eCO) level. |
| Percentage of Participants who Achieve 100% Reduction in CPD between Baseline and Month 6 Follow-Up | Month 6 | 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 | From Visit 5 (Day 56) up to 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) | Baseline, Visit 5 (Day 56) | 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 | Baseline, Month 6 | 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 | Baseline | — |
| Number of Respiratory Symptoms Reported at End of Treatment (Visit 5) | Visit 5 (Day 56) | — |
| Change from Baseline in Self-Reported CPD at End of Intervention (Visit 5) | Baseline, Visit 5 (Day 56) | Verified by exhaled carbon-monoxide (eCO) level. |
| Number of Respiratory Symptoms Reported at Month 6 Follow-up | Month 6 | — |
Countries
United States
Contacts
CONTACTOmar El-Shahawy, MD, MPH, PhD
CONTACTMohsen Abbasi, MD, MPH
PRINCIPAL_INVESTIGATOROmar El-Shahawy
NYU Langone Health
Outcome results
None listed