SmokingNCT06277271
E-cigarettes as a Harm Reduction Strategy
A study testing E-cigarette in people with Smoking, run by Prisma Health-Upstate at 1 site in United States.
Trial summary
E-cigarettes have emerged as an effective strategy for replacing cigarettes among smokers from the general population, but there is a dearth of studies investigating their utility in replacing cigarettes among smokers with opioid use disorder (OUD). Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- E-cigarette
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jun 2023to 18 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult (age ≥21)
- Report smoking ≥ 5 cigarettes per day for ≥ one year
- Interested in switching to e-cigarettes (self-reported)
- OUD diagnosis (DSM-V)(chart review)
- Currently receiving buprenorphine or other medications for opioid use disorder (MOUD) (chart review)
- Plan to remain on buprenorphine for at least 3 months (duration of the study) (self-reported)
- Have a smartphone with internet access
Who cannot join
- Use of other tobacco or nicotine products other than cigarettes (≥9 days in the past 30)
- Used nicotine replacement, bupropion or other pharmacotherapies as cessation aids in the past month (bupropion will be allowed for treatment of depression) (self-reported) (3)
- Having a severe medical condition, including decompensated cirrhosis, severe cardiovascular
- disease (myocardial infarction, percutaneous transluminal coronary angioplasty, unstable angina, coronary artery bypass graft, and/or serious arrhythmia in the
- prior 6 months) (chart review)
- Having severe asthma or chronic obstructive pulmonary disease requiring supplemental oxygen or hospitalization in the past 6 months (chart review)
Show all 15Show fewer
- Being hospitalized for human immunodeficiency virus/acquired immunodeficiency syndromes-related illness in the past 6 months (chart
- review)
- Having a history of seizure disorder (chart review)
- Pregnancy (chart review) or breast-feeding (self-reported) for female participants
- Having current DSM-V criteria for mania, psychosis, or major depressive disorder (chart review)
- Current suicidal ideation or past year suicide attempt (PHQ-9; see protections against risk)
- Being hospitalized for psychiatric reasons in the past year (chart review)
- Being unable to independently read and/or comprehend the consent form or other study materials (unable to read study materials aloud)
- Being unable to read/speak English (inability to read and complete study materials)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: E-cigarettes for Harm Reduction in Adults With Opioid Use Disorder
E-cigarettes have emerged as an effective strategy for replacing cigarettes among smokers from the general population, but there is a dearth of studies investigating their utility in replacing cigarettes among smokers with opioid use disorder (OUD). This study aims to evaluate the feasibility and acceptability of implementing a cigarette harm reduction intervention involving e-cigarettes in office-based buprenorphine clinics.
Read the detailed description
Between 84-94% of individuals with opioid use disorder (OUD) smoke cigarettes, a rate six times higher than the general US adult population. Despite the majority of smokers with OUD expressing motivation to quit, cessation rates remain extremely low, even with evidence-based medications. E-cigarettes have emerged as a harm reduction strategy for smokers unable or unwilling to quit. Research on the effectiveness of e-cigarettes for smoking reduction among individuals with OUD on buprenorphine/methadone maintenance treatment is scarce but promising. This study is an open-label single-arm clinical trial testing the use of e-cigarettes as a harm reduction strategy among smokers with OUD on buprenorphine in a real-world setting.
- Conditions
- Smoking
- Being tested
- E-cigarette
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-cigaretteOther
Participants will be supplied with an e-cigarette along with a 4-week supply of e-liquid. Participants will receive training on how to use the device and practice puffing with the e-cigarette during the research visit. They will be instructed to self-regulate administration according to their craving and withdrawal symptoms and to refrain from using other nicotine and tobacco products.
| Study group | Role | What they receive |
|---|---|---|
| E-cigarette | Experimental | Participants will be supplied with an e-cigarette along with a 4-week supply of e-liquid. Participants will receive training on how to use the device and practice puffing with the e-cigarette during the research visit. They will be instructed to self-regulate administration according to their craving and withdrawal symptoms and to refrain from using other nicotine and tobacco products. Receives: Other: E-cigarette |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of people who are eligible
Percentage of people who are screened for the study who are eligible and consent to participate in the study
Measured: Baseline
Percentage of consented participants
Percentage of consented participants will complete the study
Measured: Through study completion, 1 month follow-up
Percentage of participants who report using the e-cigarette at least once a day
Percentage of participants who report using the e-cigarette at least once a day in weeks 1-4
Measured: Week 1 to week 4
Percentage of participants with at least one puff of study e-cigarette
Percentage of participants with at least one puff of e-cigarette a day in weeks 1-4
Measured: Week 1 to week 4
Percentage of daily diary completed
Percentage of daily diary entries completed
Measured: Week 1 to week 4
Secondary outcomes (5)
Cigarette dependence measured via the Fagerstrom test for nicotine dependence
Change in cigarette dependence- baseline vs. week 4
Measured: Baseline to week 4
Cigarette demand measured via the cigarette purchase task
Change in cigarette demand- baseline vs. week 4
Measured: Baseline to Week 4
Combustible cigarette smoking
Change in average number of cigarettes consumed- baseline vs week 4
Measured: Baseline vs week 4
Switching to e-cigarettes
Percent of participants who switch to e-cigarettes by the end of week 4
Measured: week 4
Smoking reduction
Percent of participants who change their smoking by at least 50%
Measured: From baseline to Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start20 Jun 2023
- Primary completion18 Mar 2024
- Study completion18 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prisma Health-Upstate
- Sponsor type
- University, hospital or other
- Collaborators
- Clemson University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06277271
- Sponsor's protocol ID
- 1901611-9
- Status last verified
- Oct 2024
- First submitted
- 19 Jan 2024
- Last updated
- 31 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- E-cigarettes for Harm Reduction in Adults With Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT06277271
- Acronym / sponsor ID
- 1901611-9
- Conditions
- Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Prisma Health-UpstateUniversity, hospital or other
- Collaborators
- Clemson University
- Study start
- 20 Jun 2023 (actual)
- Primary completion
- 18 Mar 2024 (actual)
- Study completion
- 18 Mar 2024 (actual)
- First posted
- 26 Feb 2024 (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.
E-cigarettes have emerged as an effective strategy for replacing cigarettes among smokers from the general population, but there is a dearth of studies investigating their utility in replacing cigarettes among smokers with opioid use disorder (OUD). This study aims to evaluate the feasibility and acceptability of implementing a cigarette harm reduction intervention involving e-cigarettes in office-based buprenorphine clinics.
Detailed description
Between 84-94% of individuals with opioid use disorder (OUD) smoke cigarettes, a rate six times higher than the general US adult population. Despite the majority of smokers with OUD expressing motivation to quit, cessation rates remain extremely low, even with evidence-based medications. E-cigarettes have emerged as a harm reduction strategy for smokers unable or unwilling to quit. Research on the effectiveness of e-cigarettes for smoking reduction among individuals with OUD on buprenorphine/methadone maintenance treatment is scarce but promising. This study is an open-label single-arm clinical trial testing the use of e-cigarettes as a harm reduction strategy among smokers with OUD on buprenorphine in a real-world setting.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| E-cigarette | Experimental | Other: E-cigaretteParticipants will be supplied with an e-cigarette along with a 4-week supply of e-liquid. Participants will receive training on how to use the device and practice puffing with the e-cigarette during the research visit. They will be instructed to self-regulate administration according to their craving and withdrawal symptoms and to refrain from using other nicotine and tobacco products. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult (age ≥21)
- Report smoking ≥ 5 cigarettes per day for ≥ one year
- Interested in switching to e-cigarettes (self-reported)
- OUD diagnosis (DSM-V)(chart review)
- Currently receiving buprenorphine or other medications for opioid use disorder (MOUD) (chart review)
Key exclusion criteria (15 listed)
- Use of other tobacco or nicotine products other than cigarettes (≥9 days in the past 30)
- Used nicotine replacement, bupropion or other pharmacotherapies as cessation aids in the past month (bupropion will be allowed for treatment of depression) (self-reported) (3)
- Having a severe medical condition, including decompensated cirrhosis, severe cardiovascular
- disease (myocardial infarction, percutaneous transluminal coronary angioplasty, unstable angina, coronary artery bypass graft, and/or serious arrhythmia in the
- prior 6 months) (chart review)
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 |
|---|---|---|
| E-cigaretteParticipants will be supplied with an e-cigarette along with a 4-week supply of e-liquid. Participants will receive training on how to use the device and practice puffing with the e-cigarette during the research visit. They will be instructed to self-regulate administration according to their craving and withdrawal symptoms and to refrain from using other nicotine and tobacco products. | Other | E-cigarette |
Primary outcome
Percentage of people who are eligible
Time frame: Baseline
Percentage of people who are screened for the study who are eligible and consent to participate in the study
Percentage of consented participants
Time frame: Through study completion, 1 month follow-up
Percentage of consented participants will complete the study
Percentage of participants who report using the e-cigarette at least once a day
Time frame: Week 1 to week 4
Percentage of participants who report using the e-cigarette at least once a day in weeks 1-4
Percentage of participants with at least one puff of study e-cigarette
Time frame: Week 1 to week 4
Percentage of participants with at least one puff of e-cigarette a day in weeks 1-4
Percentage of daily diary completed
Time frame: Week 1 to week 4
Percentage of daily diary entries completed
5 secondary outcomes
Cigarette dependence measured via the Fagerstrom test for nicotine dependence
Time frame: Baseline to week 4
Cigarette demand measured via the cigarette purchase task
Time frame: Baseline to Week 4
Combustible cigarette smoking
Time frame: Baseline vs week 4
Switching to e-cigarettes
Time frame: week 4
Smoking reduction
Time frame: From baseline to Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing E-cigarette in people with Smoking, run by Prisma Health-Upstate at 1 site 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 7 inclusion and 15 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: finished, as of the sponsor's last update on 31 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of people who are eligible (time frame: Baseline). The study lists 5 primary outcomes in all. 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 31 Oct 2024.