Tobacco DependenceNCT06543407
Harm Reduction for Smokers With Mental Illness
A study testing SWITCH IT and E-cig Provision Only in people with Tobacco Dependence, run by Dartmouth-Hitchcock Medical Center at 2 sites in United States.
Trial summary
To compare the efficacy of e-cigarette (e-cig) provision with or without behavioral support (SWITCH IT) delivered via telehealth to reduce harm among smokers with MI who cannot quit smoking and are not ready to pursue cessation treatment, and to examine self-regulation (using e-cigs instead of cigarettes to cope with… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Tobacco Dependence
- What is being tested?
- SWITCH IT and E-cig Provision Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Oct 2024to 31 Mar 2028
- 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
None listed.
Who cannot join
- Currently residing in a nursing home;
- Current diagnosis of Asthma;
- Cognitive impairment (score <26 on the Telephone Interview for Cognitive Status (TICS);
- Current use of e-cigarettes (>once a week);
- Psychiatric instability (hospitalized in the past month);
- Current AND moderate to severe substance use disorder;
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- Pregnant or planning to become pregnant;
- Use of any smoked products other than cigarettes;
- Current unstable medical illness making e-cigarette unsafe (e.g., recent heart attack, cancer);
- Participation in SWITCH IT pilot study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Gail Williams, MS, MFT contact
United States2 sites, 2 recruiting
- Recruiting
Seven Counties Services
Louisville, Kentucky, 40203
Cheri Green, EdD, MSN, RN, cheri.green@sevencounties.org
Dylan Hillerich, MEd, dylan.hillerich@sevencounties.org
- Recruiting
The Providence Center
Providence, Rhode Island, 02903
Diane Beckman, PhD, 4012764020, dbeckman@careNE.org
About this study
Official title: Harm Reduction for Smokers With Mental Illness: RCT of E-cigarette Provision With or Without Behavioral Support to Boost Switching
To compare the efficacy of e-cigarette (e-cig) provision with or without behavioral support (SWITCH IT) delivered via telehealth to reduce harm among smokers with MI who cannot quit smoking and are not ready to pursue cessation treatment, and to examine self-regulation (using e-cigs instead of cigarettes to cope with stress/distress and self-efficacy) as a potential mechanism for behavior change from SWITCH IT
- Conditions
- Tobacco Dependence
- Being tested
- SWITCH IT, E-cig Provision Only
- Keywords
- serious mental illness, harm reduction, e-cigarettes
- Medical subject headings
- Tobacco Use Disorder, Harm Reduction, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SWITCH ITBehavioural
Behavioral support for switching, 7-10 sessions with SWITCH IT coach delivered during the first 8 weeks of the study. SWITCH IT participants will also have the opportunity to receive supported "field trips" to explore e-cigarette options based on availability, cost, and preferences during week 4 and week 6.
E-cig Provision OnlyOther
Provision of e-cigarettes (NJOY) based on combusible use for the first 8 weeks of the study.
| Study group | Role | What they receive |
|---|---|---|
| E-cigarette provision only | Active comparator | Participants randomized to this condition will receive a supply of NJOY Daily e-cigarettes for the first 8 weeks of the study. Receives: Other: E-cig Provision Only |
| SWITCH IT | Experimental | Participants randomized to this condition will receive a supply of e-cigarettes and behavioral support and coaching, protocolized intervention, SWITCH IT, for the first 8 weeks of the study. Receives: Behavioral: SWITCH IT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Urine NNAL
urine levels of NNAL
Measured: baseline to 8 weeks, 8 weeks to 26 weeeks
Change in CO level
carbon monixide level less than 6
Measured: baseline to 8 weeks, 8 weeks to 26 weeks
Change in self-reported cigarette use
self-report of combustible cigarette use
Measured: baseline to 8 weeks 8 weeks to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start1 Oct 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco DependenceStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Dartmouth College, Fordham University, Seven Counties Services, Western Michigan University School of Medicine, National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Sarah Pratt, Dartmouth-Hitchcock Medical Center
- Investigators
- Sarah I. Pratt, PhD, Principal investigator, Dartmouth Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06543407
- Sponsor's protocol ID
- 02002328
- Other IDs
- R01DA057729-01A1
- Status last verified
- Nov 2025
- First submitted
- 5 Aug 2024
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Harm Reduction for Smokers With Mental Illness: RCT of E-cigarette Provision With or Without Behavioral Support to Boost Switching
- ClinicalTrials.gov ID
- NCT06543407
- Acronym / sponsor ID
- 02002328
- Conditions
- Tobacco Dependence
- Keywords
- serious mental illness, harm reduction, e-cigarettes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Dartmouth College, Fordham University, Seven Counties Services, Western Michigan University School of Medicine, National Institute on Drug Abuse (NIDA)
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 9 Aug 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.
To compare the efficacy of e-cigarette (e-cig) provision with or without behavioral support (SWITCH IT) delivered via telehealth to reduce harm among smokers with MI who cannot quit smoking and are not ready to pursue cessation treatment, and to examine self-regulation (using e-cigs instead of cigarettes to cope with stress/distress and self-efficacy) as a potential mechanism for behavior change from SWITCH IT
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| E-cigarette provision only | Active comparator | Other: E-cig Provision OnlyParticipants randomized to this condition will receive a supply of NJOY Daily e-cigarettes for the first 8 weeks of the study. |
| SWITCH IT | Experimental | Behavioral: SWITCH ITParticipants randomized to this condition will receive a supply of e-cigarettes and behavioral support and coaching, protocolized intervention, SWITCH IT, for the first 8 weeks of the study. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- Currently residing in a nursing home;
- Current diagnosis of Asthma;
- Cognitive impairment (score <26 on the Telephone Interview for Cognitive Status (TICS);
- Current use of e-cigarettes (>once a week);
- Psychiatric instability (hospitalized in the past month);
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 |
|---|---|---|
| SWITCH ITBehavioral support for switching, 7-10 sessions with SWITCH IT coach delivered during the first 8 weeks of the study. SWITCH IT participants will also have the opportunity to receive supported "field trips" to explore e-cigarette options based on availability, cost, and preferences during week 4 and week 6. | Behavioural | SWITCH IT |
| E-cig Provision OnlyProvision of e-cigarettes (NJOY) based on combusible use for the first 8 weeks of the study. | Other | E-cigarette provision only |
Primary outcome
Change in Urine NNAL
Time frame: baseline to 8 weeks, 8 weeks to 26 weeeks
urine levels of NNAL
Change in CO level
Time frame: baseline to 8 weeks, 8 weeks to 26 weeks
carbon monixide level less than 6
Change in self-reported cigarette use
Time frame: baseline to 8 weeks 8 weeks to 16 weeks
self-report of combustible cigarette use
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 15 Jan 2026.
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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.
Gail Williams, MS, MFT contact
Sarah I. Pratt, PhD principal investigator
Dartmouth Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SWITCH IT and E-cig Provision Only in people with Tobacco Dependence, run by Dartmouth-Hitchcock Medical Center at 2 sites 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 0 inclusion and 10 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 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Meghan M. Santos, MSW (978-494-4260, meghan.m.santos@hitchcock.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Urine NNAL (time frame: baseline to 8 weeks, 8 weeks to 26 weeeks). The study lists 3 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 15 Jan 2026.