Tobacco-flavored ECSWITCHNCT07202039
Electronic Cigarettes as a Harm Reduction Strategy Among People With Opioid Use Disorder on Buprenorphine
A study testing Brief individual counseling sessions in people with Tobacco-flavored EC and Sweet-Cooling EC, run by Prisma Health-Upstate at 1 site in United States.
Trial summary
This project aims to investigate the impact of e-cigarette flavors and usage patterns on achieving harm-reduction milestones in a sample of cigarette smokers with opioid use disorder who are taking buprenorphine Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Tobacco-flavored EC, Sweet-Cooling EC, Sweet Non-cooling EC
- What is being tested?
- Brief individual counseling sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2026to 29 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Age ≥21 years
- Smoke ≥5 CPD for ≥1 year
- Daily CC smoker
- Willing to switch to EC
- Exhaled CO ≥6 ppm
- Diagnosed with OUD
Show all 22Show fewer
- Stable on bupropion treatment
- In good physical and mental health
- Able to use a smartphone
- Willing to participate in all study components
- Able to provide informed consent Exclusion Criteria
- Interested in quitting CC (contemplation stage of change)
- Use of EC on ≥4 of the past 30 days
- Use of other tobacco products (e.g., cigars, smokeless tobacco) on ≥9 days of the past 30 days
- Use of nicotine replacement therapy, smoking cessation medication, or a cessation attempt in the past 30 days
- Hypertension
- Medical condition that would contraindicate participation
- Meet DSM-V criteria for major depressive episode, psychotic episode, or manic episode
- Current suicidal ideation or suicide attempt in the past year
- Psychiatric hospitalization in the past year
- Contemplating pregnancy, currently pregnant, or breastfeeding
- Unable to speak and/or read English
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Addiction Medicine Center
Greenville, South Carolina, 29605
Alain Litwin, MD, 864-455-5648, alain.litwin@prismahealth.org
About this study
This project aims to investigate the impact of e-cigarette flavors and usage patterns on achieving harm-reduction milestones in a sample of cigarette smokers with opioid use disorder who are taking buprenorphine
- Conditions
- Tobacco-flavored EC, Sweet-Cooling EC, Sweet Non-cooling EC
- Being tested
- Brief individual counseling sessions
- Keywords
- Cigarette Smoking, Opioid use disorder, Burprenorphine, Electronic cigarettes, Switching, Flavors
- Medical subject headings
- Cigarette Smoking, Opioid-Related Disorders, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief individual counseling sessionsBehavioural
Five brief, individual counseling sessions will provide education, behavioral support, and motivational strategies to facilitate switching from combustible cigarette use to EC
| Study group | Role | What they receive |
|---|---|---|
| Sweet-Cooling EC + Counseling | Experimental | Those randomized to the intervention group will be provided a free 12-week supply of sweet-cooling electronic cigarette (EC) liquid and five brief, individual counseling sessions, and asked to try to switch completely to EC. Receives: Behavioral: Brief individual counseling sessions |
| Sweet non-cooling EC + Counseling | Experimental | Those randomized to the intervention group will be provided a free 12-week supply of sweet non-cooling electronic cigarette (EC) liquid and five brief, individual counseling sessions, and asked to try to switch completely to EC. Receives: Behavioral: Brief individual counseling sessions |
| Tobacco-flavored EC + Counseling | Active comparator | Those randomized to the intervention group will be provided a free 12-week supply of tobacco-flavored electronic cigarette (EC) liquid and five brief, individual counseling sessions, and asked to try to switch completely to EC. Receives: Behavioral: Brief individual counseling sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cigarettes smoked per day
The average change in mean CPD on a 7-day TLFB assessment from baseline (week 0) to weeks 12
Measured: Baseline to week 12
Secondary outcomes (6)
Change in cigarettes smoked per day
The average change in mean CPD on a 7-day TLFB assessment from baseline (week 0) to week 24
Measured: Baseline to week 24
Percentage of participants with a ≥50% reduction in CPD
The rate of participants achieving an average ≥50% reduction in CPD from baseline (week 0) to weeks 12 and 26, based on a 7-day TLFB
Measured: Baseline to weeks 12 and 26
Switching
Proportion of participants reporting exclusive EC use and no CC use on a 7-day TLFB with CO <6 ppm.
Measured: Weeks 12 and 24
Partial Switching
Proportion of participants reporting both EC and CC use on a 7-day TLFB with a ≥50% reduction in CPD.
Measured: Weeks 12 and 24
7-Day CC Abstinence
Percentage of participants with biochemically verified 7-day abstinence (1 = abstinent, 0 = non-abstinent). Defined as self-reported no CC use on a 7-day TLFB with CO <6 ppm.
Measured: Weeks 12 and 26
Change in carbon monoxide levels
Change in exhaled CO levels from baseline (week 0) to weeks 12 and 26 (continuous variable).
Measured: Baselone to weeks 12 and 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start29 Apr 2026
- Primary completion30 Mar 2029 (estimated)
- Study completion29 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco-flavored ECStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Prisma Health-Upstate
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Irene Pericot-Valverde, Clemson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07202039
- Sponsor's protocol ID
- 2328661-1
- Other IDs
- K01DA062708
- Acronym
- SWITCH
- Status last verified
- May 2026
- First submitted
- 23 Sep 2025
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic Cigarettes as a Harm Reduction Strategy Among People With Opioid Use Disorder on Buprenorphine
- ClinicalTrials.gov ID
- NCT07202039
- Acronym / sponsor ID
- SWITCH / 2328661-1
- Conditions
- Tobacco-flavored EC, Sweet-Cooling EC, Sweet Non-cooling EC
- Keywords
- Cigarette Smoking, Opioid use disorder, Burprenorphine, Electronic cigarettes, Switching, Flavors
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Prisma Health-UpstateUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 29 Apr 2026 (actual)
- Primary completion
- 30 Mar 2029 (estimated)
- Study completion
- 29 Jun 2029 (estimated)
- First posted
- 1 Oct 2025 (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 project aims to investigate the impact of e-cigarette flavors and usage patterns on achieving harm-reduction milestones in a sample of cigarette smokers with opioid use disorder who are taking buprenorphine
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sweet-Cooling EC + Counseling | Experimental | Behavioral: Brief individual counseling sessionsThose randomized to the intervention group will be provided a free 12-week supply of sweet-cooling electronic cigarette (EC) liquid and five brief, individual counseling sessions, and asked to try to switch completely to EC. |
| Sweet non-cooling EC + Counseling | Experimental | Behavioral: Brief individual counseling sessionsThose randomized to the intervention group will be provided a free 12-week supply of sweet non-cooling electronic cigarette (EC) liquid and five brief, individual counseling sessions, and asked to try to switch completely to EC. |
| Tobacco-flavored EC + Counseling | Active comparator | Behavioral: Brief individual counseling sessionsThose randomized to the intervention group will be provided a free 12-week supply of tobacco-flavored electronic cigarette (EC) liquid and five brief, individual counseling sessions, and asked to try to switch completely to EC. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- Age ≥21 years
- Smoke ≥5 CPD for ≥1 year
- Daily CC smoker
- Willing to switch to EC
- Exhaled CO ≥6 ppm
Key exclusion criteria (0 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 |
|---|---|---|
| Brief individual counseling sessionsFive brief, individual counseling sessions will provide education, behavioral support, and motivational strategies to facilitate switching from combustible cigarette use to EC | Behavioural | Sweet non-cooling EC + Counseling, Sweet-Cooling EC + Counseling, Tobacco-flavored EC + Counseling |
Primary outcome
Change in cigarettes smoked per day
Time frame: Baseline to week 12
The average change in mean CPD on a 7-day TLFB assessment from baseline (week 0) to weeks 12
6 secondary outcomes
Change in cigarettes smoked per day
Time frame: Baseline to week 24
Percentage of participants with a ≥50% reduction in CPD
Time frame: Baseline to weeks 12 and 26
Switching
Time frame: Weeks 12 and 24
Partial Switching
Time frame: Weeks 12 and 24
7-Day CC Abstinence
Time frame: Weeks 12 and 26
Change in carbon monoxide levels
Time frame: Baselone to weeks 12 and 26
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief individual counseling sessions in people with Tobacco-flavored EC and Sweet-Cooling EC, 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 22 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 12 May 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Irene Pericot-Valverde, PhD ((864)656-4467, iperico@clemson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cigarettes smoked per day (time frame: Baseline to week 12). 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 12 May 2026; AzTrials last refreshed its copy on 31 Oct 2026.