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New treatment option for Opioid Use Disorder
Official title E-Cigarettes for Harm Reduction in Smokers With Opioid Use Disorder
ClinicalTrials.gov ID: NCT05722561
What this study is testing
What is Nicotine Replacement Product?
Nicotine Replacement Product is an investigational medicine, being studied as a potential treatment for opioid use disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 75
You may be able to join if
- 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
You likely can't join if
- 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...
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
- The Bronx, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States; The Bronx, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.