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NCT Number: NCT07743710

The SMOKE Telehealth 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?

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.

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Key information

Conditions

Tobacco Smoking Behavior Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Smoking Tobacco Use

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Binghamton University

Binghamton, New York, 13905, United States

Location status: Recruiting

Location contact

Emily Zale

CONTACT

[email protected]

7196507236

Emily Zale

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • moderate to severe chronic pain
  • current daily tobacco smoking
  • willing and able to complete study components in English
  • adult (age 18 or over)

Exclusion criteria

  • planning or currently attempting to quit
  • recent use of cessation treatments or other products to quit smoking

Treatment and study plan

Smoking and Health Telehealth Intervention 1

Behavioral

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 2

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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

    Separate ratings of motivation, importance, readiness, and confidence in quitting smoking on a scale from 0 (none) to 10 (100%).

  2. 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

    Self-reported (yes/no) willingness to learn about cessation treatments and accept cessation resources, and intention to use cessation treatments.

  3. Cessation Treatment Engagement

    Time frame: 2-week, 1-month, 3-month follow-up

    Self-reported (yes/no) use of cessation treatment.

  4. 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

    The Pain and Smoking Inventory measures the extent to which people believe their smoking and pain are related.

  5. 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

    The Pain and Smoking Questionnaire measures the extent to which participants can correctly identify known associations between smoking and multiple health conditions.

Study contacts

Contact information is provided by the study sponsor or research team.

Emily Zale

CONTACT

[email protected]

607-777-3381

Sponsors and collaborators

Lead sponsor

Binghamton University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 4, 2026
Registry last updated
Aug 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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