Effects of E-Cigarette Flavors on Adult E-Cigarette Users With Opioid Use Disorder (FLAVOR)

July 30, 2026 updated by: Prisma Health-Upstate

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Irene Pericot-Valverde, PhD
  • Phone Number: (864)656-4467 18549998005
  • Email: iperico@clemson.edu

Study Locations

  • United States
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Prisma Health Recovery Clinic-Greenville

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

E-cigarette users with opioid use disorder receiving burpenorphine

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline session
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.
Baseline session
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.
Baseline session
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.
Baseline session
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.
Baseline session
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.
Baseline session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Prisma Health-Upstate

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 12, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 28, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 28, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 13, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 19, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2328661-2
  • K01DA062708 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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