Tobacco SmokingNCT07743710
The SMOKE Telehealth Study
A study testing Smoking and Health Telehealth Intervention 1 and Smoking and Health Telehealth Intervention 2 in people with Tobacco Smoking, run by Binghamton University at 1 site in United States.
Trial summary
The goal of this clinical trial is to develop two health-focused interventions for tobacco smokers with chronic pain. The main questions it aims to answer are: Are the interventions feasible for delivery via telehealth? Are the interventions acceptable to participants? This study has two phases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Smoking
- What is being tested?
- Smoking and Health Telehealth Intervention 1 and Smoking and Health Telehealth Intervention 2
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to Jul 2027
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- moderate to severe chronic pain
- current daily tobacco smoking
- willing and able to complete study components in English
- adult (age 18 or over)
Who cannot join
- planning or currently attempting to quit
- recent use of cessation treatments or other products to quit smoking
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
Binghamton University
Binghamton, New York, 13905
Emily Zale, 7196507236, ezale@binghamton.edu
Emily Zale
About this study
The goal of this clinical trial is to develop two health-focused interventions for tobacco smokers with chronic pain. The main questions it aims to answer are:
- Are the interventions feasible for delivery via telehealth?
- Are the interventions acceptable to participants?
Read more
This study has two phases. First, researchers will develop materials and receive feedback through three focus groups, updating the materials iteratively between each group. Next, researchers will compare the feasibility and acceptability of the two interventions.
Participants in the second phase will:
- Complete the a single-session telehealth intervention online
- Complete surveys online before, immediately after, and at 2-weeks, 1-month, and 3-months after the intervention session.
- Conditions
- Tobacco Smoking
- Being tested
- Smoking and Health Telehealth Intervention 1, Smoking and Health Telehealth Intervention 2
- Keywords
- tobacco smoking, chronic pain
- Medical subject headings
- Tobacco Smoking, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking and Health Telehealth Intervention 1Behavioural
The Smoking and Health Telehealth Intervention 1 provides educational information about how smoking is related to health and resources for smoking cessation. The intervention is delivered via live telehealth online in a single (30 minute) session.
Smoking and Health Telehealth Intervention 2Behavioural
The Smoking and Health Telehealth Intervention 2 provides educational information about how smoking is related to health and resources for smoking cessation. The intervention is delivered via live telehealth online in a single (30 minute) session.
| Study group | Role | What they receive |
|---|---|---|
| Smoking and Health Intervention 1 | Experimental | Not described Receives: Behavioral: Smoking and Health Telehealth Intervention 1 |
| Smoking and Health Intervention 2 | Experimental | Not described Receives: Behavioral: Smoking and Health Telehealth Intervention 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Feasibility
Enroll >80% or more of people who meet eligibility criteria.
Measured: At the participant level, time from screening through enrollment is anticipated to be up to 4 weeks. The total will be calculated at the end of the entire enrollment period of the study, which is anticipated to be approximately 1 year and 9 months.
Intervention Delivery Feasbility
Delivery of the allocated intervention to at least 95% of enrolled participants.
Measured: At the participant level, intervention delivery occurs in the same session as enrollment. Overall feasibility will be assessed at the end of the entire enrollment period, which is anticipated to be 1 year and 9 months.
Acceptability
Mean scores for each item on the Client Satisfaction Questionnaire (CSQ) of 3 or greater. Mean total CSQ score of 24 or greater.
Measured: Immediately post intervention (at the end of the intervention session).
Secondary outcomes (5)
Cessation Motivation
Separate ratings of motivation, importance, readiness, and confidence in quitting smoking on a scale from 0 (none) to 10 (100%).
Measured: Assessed immediately before and after the intervention (during the interventions session), and at 2-weeks, 1-month, and 3-months after the intervention session
Motivation for Cessation Treatment
Self-reported (yes/no) willingness to learn about cessation treatments and accept cessation resources, and intention to use cessation treatments.
Measured: Assessed immediately before and after the intervention (during the interventions session), and at 2-weeks, 1-month, and 3-months after the intervention session
Cessation Treatment Engagement
Self-reported (yes/no) use of cessation treatment.
Measured: 2-week, 1-month, 3-month follow-up
Pain and Smoking Inventory
The Pain and Smoking Inventory measures the extent to which people believe their smoking and pain are related.
Measured: Assessed immediately before and after the intervention (during the interventions session), and at 2-weeks, 1-month, and 3-months after the intervention session
Pain and Smoking Questionnaire
The Pain and Smoking Questionnaire measures the extent to which participants can correctly identify known associations between smoking and multiple health conditions.
Measured: Assessed immediately before and after the intervention (during the interventions session), and at 2-weeks, 1-month, and 3-months after the intervention session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Binghamton University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Emily Zale, Binghamton University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07743710
- Sponsor's protocol ID
- STUDY00005796
- Other IDs
- R21DA060345-01A1
- Status last verified
- Jul 2026
- First submitted
- 24 Jul 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified self-report measures will be submitted to the National Institute of Mental Health Data Archive (NDA) at the National Institutes of Health.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The SMOKE Telehealth Study
- ClinicalTrials.gov ID
- NCT07743710
- Acronym / sponsor ID
- STUDY00005796
- Conditions
- Tobacco Smoking
- Keywords
- tobacco smoking, chronic pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Binghamton UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 4 Aug 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.
The goal of this clinical trial is to develop two health-focused interventions for tobacco smokers with chronic pain. The main questions it aims to answer are:
- Are the interventions feasible for delivery via telehealth?
- Are the interventions acceptable to participants?
This study has two phases. First, researchers will develop materials and receive feedback through three focus groups, updating the materials iteratively between each group. Next, researchers will compare the feasibility and acceptability of the two interventions.
Participants in the second phase will:
- Complete the a single-session telehealth intervention online
- Complete surveys online before, immediately after, and at 2-weeks, 1-month, and 3-months after the intervention session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smoking and Health Intervention 1 | Experimental | Behavioral: Smoking and Health Telehealth Intervention 1 |
| Smoking and Health Intervention 2 | Experimental | Behavioral: Smoking and Health Telehealth Intervention 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- moderate to severe chronic pain
- current daily tobacco smoking
- willing and able to complete study components in English
- adult (age 18 or over)
Key exclusion criteria (2 listed)
- planning or currently attempting to quit
- recent use of cessation treatments or other products to quit smoking
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 |
|---|---|---|
| Smoking and Health Telehealth Intervention 1The Smoking and Health Telehealth Intervention 1 provides educational information about how smoking is related to health and resources for smoking cessation. The intervention is delivered via live telehealth online in a single (30 minute) session. | Behavioural | Smoking and Health Intervention 1 |
| Smoking and Health Telehealth Intervention 2The Smoking and Health Telehealth Intervention 2 provides educational information about how smoking is related to health and resources for smoking cessation. The intervention is delivered via live telehealth online in a single (30 minute) session. | Behavioural | Smoking and Health Intervention 2 |
Primary outcome
Recruitment Feasibility
Time frame: At the participant level, time from screening through enrollment is anticipated to be up to 4 weeks. The total will be calculated at the end of the entire enrollment period of the study, which is anticipated to be approximately 1 year and 9 months.
Enroll >80% or more of people who meet eligibility criteria.
Intervention Delivery Feasbility
Time frame: At the participant level, intervention delivery occurs in the same session as enrollment. Overall feasibility will be assessed at the end of the entire enrollment period, which is anticipated to be 1 year and 9 months.
Delivery of the allocated intervention to at least 95% of enrolled participants.
Acceptability
Time frame: Immediately post intervention (at the end of the intervention session).
Mean scores for each item on the Client Satisfaction Questionnaire (CSQ) of 3 or greater. Mean total CSQ score of 24 or greater.
5 secondary outcomes
Cessation Motivation
Time frame: Assessed immediately before and after the intervention (during the interventions session), and at 2-weeks, 1-month, and 3-months after the intervention session
Motivation for Cessation Treatment
Time frame: Assessed immediately before and after the intervention (during the interventions session), and at 2-weeks, 1-month, and 3-months after the intervention session
Cessation Treatment Engagement
Time frame: 2-week, 1-month, 3-month follow-up
Pain and Smoking Inventory
Time frame: Assessed immediately before and after the intervention (during the interventions session), and at 2-weeks, 1-month, and 3-months after the intervention session
Pain and Smoking Questionnaire
Time frame: Assessed immediately before and after the intervention (during the interventions session), and at 2-weeks, 1-month, and 3-months after the intervention session
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 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified self-report measures will be submitted to the National Institute of Mental Health Data Archive (NDA) at the National Institutes of Health.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smoking and Health Telehealth Intervention 1 and Smoking and Health Telehealth Intervention 2 in people with Tobacco Smoking, run by Binghamton University 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 4 inclusion and 2 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 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?
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 Emily Zale (607-777-3381, ezale@binghamton.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment Feasibility (time frame: At the participant level, time from screening through enrollment is anticipated to be up to 4 weeks. The total will be calculated at the end of the entire enrollment period of the study, which is anticipated to be approximately 1 year and 9 months.). 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 12 Aug 2026.