Nicotine Use DisoderFLAVORNCT07594717
Effects of E-Cigarette Flavors on Adult E-Cigarette Users With Opioid Use Disorder
An observational study of Nicotine Use Disoder and Opioid Use Disorder, run by Prisma Health-Upstate at 1 site in United States.
Trial summary
This study examines the effects of e-cigarette (EC) flavors among adults with opioid use disorder (OUD) receiving buprenorphine treatment who currently use e-cigarettes. Participants will smell and rate 11 EC flavors based on appeal, sensory characteristics, and likelihood of future use. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Nicotine Use Disoder, Opioid Use Disorder
- What is being tested?
- Sweet-cooling, Sweet non-cooling EC flavor and Tobacco flavor EC
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2025to 28 Apr 2026
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: E-cigarette users with opioid use disorder receiving burpenorphine
Who may be able to join
- Adults aged 21 years or older.
- Current e-cigarette users who report e-cigarette use on ≥20 of the past 30 days.
- Former daily cigarette smokers who currently smoke on ≤19 days per month and no more than 5 cigarettes per day.
- Diagnosed with opioid use disorder (OUD).
- Currently receiving buprenorphine treatment for OUD.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Prisma Health Recovery Clinic-Greenville
Greenville, South Carolina, 29605
About this study
Official title: Effects of E-Cigarette Flavors on Adult E-Cigarette Users With Opioid Use Disorder Receiving Buprenorphine
This study examines the effects of e-cigarette (EC) flavors among adults with opioid use disorder (OUD) receiving buprenorphine treatment who currently use e-cigarettes. Participants will smell and rate 11 EC flavors based on appeal, sensory characteristics, and likelihood of future use. Researchers will examine how different flavor profiles influence the appeal and reinforcing effects of ECs in this population. The goal is to identify EC flavors that may enhance the acceptability of ECs as a potential harm-reduction strategy among adults with OUD receiving buprenorphine treatment.
Read the detailed description
This study examines the effects of e-cigarette (EC) flavors among adults with opioid use disorder (OUD) who are receiving buprenorphine treatment and currently use e-cigarettes. Participants will complete a brief session in which they will smell and rate 11 EC flavors based on their appeal, sensory characteristics, and likelihood of future use. Researchers will examine how different flavor profiles influence the appeal, positive subjective effects, and reinforcing potential of EC flavors in this population. The goal of the study is to identify one or more EC flavors that may enhance the acceptability and reinforcing effects of ECs as a potential harm-reduction strategy among adults with OUD receiving buprenorphine treatment.
- Conditions
- Nicotine Use Disoder, Opioid Use Disorder
- Being tested
- Sweet-cooling, Sweet non-cooling EC flavor, Tobacco flavor EC
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sweet-coolingDrug
Sweet-cooling EC flavor
Sweet non-cooling EC flavorDrug
Sweet non-cooling flavor
Tobacco flavor ECDrug
Tobacco flavor EC
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Sweetness
Perceived sweetness of each e-cigarette flavor will be assessed using a one-item VAS ranging from "Not sweet at all" to "Extremely sweet," with higher scores indicating greater perceived sweetness.
Measured: Baseline session
Perceived Coolness/Freshness
Perceived coolness/freshness of each e-cigarette flavor will be assessed using a one-item VAS ranging from "Not cool/fresh at all" to "Extremely cool/fresh," with higher scores indicating greater perceived coolness/freshness.
Measured: Baseline session
Perceived Flavor Strength
Perceived flavor strength will be assessed using a one-item VAS ranging from "Very weak" to "Very strong," with higher scores indicating greater perceived flavor strength.
Measured: Baseline session
Perceived Harshness/Irritation
Perceived harshness/irritation of each e-cigarette flavor will be assessed using a one-item VAS ranging from "Not harsh/irritating at all" to "Extremely harsh/irritating," with higher scores indicating greater perceived harshness/irritation.
Measured: Baseline session
Flavor Liking
Flavor liking will be assessed using a one-item VAS ranging from "Not at all" to "Extremely," with higher scores indicating greater liking of the flavor.
Measured: Baseline session
Likelihood of Future Use
Likelihood of future use will be assessed using a one-item VAS ranging from "Not at all" to "Definitely," with higher scores indicating greater likelihood of future use of the flavor.
Measured: Baseline session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start12 Nov 2025
- Primary completion28 Apr 2026
- Study completion28 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine Use DisoderStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prisma Health-Upstate
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07594717
- Sponsor's protocol ID
- 2328661-2
- Other IDs
- K01DA062708
- Acronym
- FLAVOR
- Status last verified
- Jul 2026
- First submitted
- 13 May 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of E-Cigarette Flavors on Adult E-Cigarette Users With Opioid Use Disorder Receiving Buprenorphine
- ClinicalTrials.gov ID
- NCT07594717
- Acronym / sponsor ID
- FLAVOR / 2328661-2
- Conditions
- Nicotine Use Disoder, Opioid Use Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Prisma Health-UpstateUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 12 Nov 2025 (actual)
- Primary completion
- 28 Apr 2026 (actual)
- Study completion
- 28 Apr 2026 (actual)
- First posted
- 19 May 2026 (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.
This study examines the effects of e-cigarette (EC) flavors among adults with opioid use disorder (OUD) receiving buprenorphine treatment who currently use e-cigarettes. Participants will smell and rate 11 EC flavors based on appeal, sensory characteristics, and likelihood of future use. Researchers will examine how different flavor profiles influence the appeal and reinforcing effects of ECs in this population. The goal is to identify EC flavors that may enhance the acceptability of ECs as a potential harm-reduction strategy among adults with OUD receiving buprenorphine treatment.
Detailed description
This study examines the effects of e-cigarette (EC) flavors among adults with opioid use disorder (OUD) who are receiving buprenorphine treatment and currently use e-cigarettes. Participants will complete a brief session in which they will smell and rate 11 EC flavors based on their appeal, sensory characteristics, and likelihood of future use. Researchers will examine how different flavor profiles influence the appeal, positive subjective effects, and reinforcing potential of EC flavors in this population. The goal of the study is to identify one or more EC flavors that may enhance the acceptability and reinforcing effects of ECs as a potential harm-reduction strategy among adults with OUD receiving buprenorphine treatment.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- E-cigarette users with opioid use disorder receiving burpenorphine
Key inclusion criteria (5 listed)
- Adults aged 21 years or older.
- Current e-cigarette users who report e-cigarette use on ≥20 of the past 30 days.
- Former daily cigarette smokers who currently smoke on ≤19 days per month and no more than 5 cigarettes per day.
- Diagnosed with opioid use disorder (OUD).
- Currently receiving buprenorphine treatment for OUD.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Sweet-coolingSweet-cooling EC flavor | Drug | – |
| Sweet non-cooling EC flavorSweet non-cooling flavor | Drug | – |
| Tobacco flavor ECTobacco flavor EC | Drug | – |
Primary outcome
Perceived Sweetness
Time frame: Baseline session
Perceived sweetness of each e-cigarette flavor will be assessed using a one-item VAS ranging from "Not sweet at all" to "Extremely sweet," with higher scores indicating greater perceived sweetness.
Perceived Coolness/Freshness
Time frame: Baseline session
Perceived coolness/freshness of each e-cigarette flavor will be assessed using a one-item VAS ranging from "Not cool/fresh at all" to "Extremely cool/fresh," with higher scores indicating greater perceived coolness/freshness.
Perceived Flavor Strength
Time frame: Baseline session
Perceived flavor strength will be assessed using a one-item VAS ranging from "Very weak" to "Very strong," with higher scores indicating greater perceived flavor strength.
Perceived Harshness/Irritation
Time frame: Baseline session
Perceived harshness/irritation of each e-cigarette flavor will be assessed using a one-item VAS ranging from "Not harsh/irritating at all" to "Extremely harsh/irritating," with higher scores indicating greater perceived harshness/irritation.
Flavor Liking
Time frame: Baseline session
Flavor liking will be assessed using a one-item VAS ranging from "Not at all" to "Extremely," with higher scores indicating greater liking of the flavor.
Likelihood of Future Use
Time frame: Baseline session
Likelihood of future use will be assessed using a one-item VAS ranging from "Not at all" to "Definitely," with higher scores indicating greater likelihood of future use of the flavor.
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 3 Aug 2026.
- Individual participant dataSharing planned: Undecided
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?
An observational study of Nicotine Use Disoder and Opioid Use Disorder, 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 5 inclusion and 1 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 3 Aug 2026. 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?
Perceived Sweetness (time frame: Baseline session). The study lists 6 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 3 Aug 2026.