E-sigaretten voor schadebeperking bij rokers met opioïdengebruiksstoornis
Effectiviteit en impact van counseling verbeterd met elektronische sigaretten voor vermindering van schade bij rokers met opioïdengebruiksstoornis
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.
Studie Overzicht
Toestand
Conditie
Studietype
Inschrijving (Geschat)
Fase
- Fase 2
Contacten en locaties
Studiecontact
- Naam: Omar El-Shahawy, MD, MPH, PhD
- Telefoonnummer: 646-501-3587
- E-mail: Omar.ElShahawy@nyulangone.org
Studie Contact Back-up
- Naam: Mohsen Abbasi, MD, MPH
- Telefoonnummer: 646-501-3581
- E-mail: Mohsen.Abbasikangevari@nyulangone.org
Studie Locaties
-
-
New York
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New York, New York, Verenigde Staten, 10016
- Werving
- NYU Langone Health
-
Contact:
- Omar El-Shahawy
- Telefoonnummer: 646-501-3587
- E-mail: Omar.ElShahawy@nyulangone.org
-
The Bronx, New York, Verenigde Staten, 10461
- Nog niet aan het werven
- Albert Einstein College of Medicine
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Hoofdonderzoeker:
- Shadi Nahvi, MD
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Electronic Cigarette
Participants in the Electronic Cigarette (EC) arm will receive telehealth motivational counseling for 5 weeks plus the standardized research e-cigarette (SREC). |
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.
Apparaat: 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. |
|
Actieve vergelijker: Nicotine Replacement Therapy
Participants in the Nicotine Replacement Therapy (NRT) arm will receive telehealth motivational counseling plus combination NRT (patch and lozenge). |
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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Percentage of Participants who Achieve 100% Reduction in Cigarettes Per Day (CPD) between Baseline and End of Intervention (Visit 5)
Tijdsspanne: Up to Visit 5 (Day 56)
|
Verified by exhaled carbon-monoxide (eCO) level. |
Up to Visit 5 (Day 56)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Aantal ademhalingssymptomen gerapporteerd bij baseline
Tijdsspanne: Basislijn
|
Basislijn
|
|
|
Aantal gerapporteerde ademhalingssymptomen aan het einde van de behandeling (bezoek 5)
Tijdsspanne: Bezoek 5 (dag 56)
|
Bezoek 5 (dag 56)
|
|
|
Aantal ademhalingssymptomen gemeld bij de follow-up van maand 6
Tijdsspanne: Maand 6
|
Maand 6
|
|
|
Percentage of Participants who Achieve 100% Reduction in CPD between Baseline and Month 6 Follow-Up
Tijdsspanne: Month 6
|
Verified by exhaled carbon-monoxide (eCO) level. |
Month 6
|
|
Percentage of Participants who Achieve 100% Reduction in CPD between End of Intervention (Visit 5) and Month 6 Follow-Up
Tijdsspanne: From Visit 5 (Day 56) up to Month 6
|
Verified by exhaled carbon-monoxide (eCO) level. |
From Visit 5 (Day 56) up to Month 6
|
|
Change from Baseline in Self-Reported CPD at End of Intervention (Visit 5)
Tijdsspanne: Baseline, Visit 5 (Day 56)
|
Verified by exhaled carbon-monoxide (eCO) level. |
Baseline, Visit 5 (Day 56)
|
|
Change from Baseline in Self-Reported CPD at Month 6
Tijdsspanne: Baseline, Month 6
|
Verified by exhaled carbon-monoxide (eCO) level. |
Baseline, Month 6
|
|
Change from Baseline in Health-Related Quality of Life (HRQOL) Survey Score at End of Intervention (Visit 5)
Tijdsspanne: 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. |
Baseline, Visit 5 (Day 56)
|
|
Change from Baseline in Health-Related Quality of Life (HRQOL) Survey Score at Month 6 Follow-up
Tijdsspanne: 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. |
Baseline, Month 6
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Omar El-Shahawy, NYU Langone Health
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
- Narcotica-gerelateerde aandoeningen
- Psychische aandoening
- Middelgerelateerde aandoeningen
- Chemisch veroorzaakte aandoeningen
- Gedrag
- Gezondheidsgedrag
- Tabak roken
- Tabak gebruik
- Aan opioïden gerelateerde aandoeningen
- Roken
- Sigaretten roken
- Vermindering van roken
- Therapeutica
- Tabaksgebruik -apparaten gebruiken
Andere studie-ID-nummers
- 22-00661
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
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-tijdsbestek voor delen
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD-toegangscriteria voor delen
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.
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
Informatie over medicijnen en apparaten, studiedocumenten
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product vervaardigd in en geëxporteerd uit de V.S.
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