The SMOKE Telehealth Study

NCT07743710 | Recruiting

• 2 other identifiers: STUDY00005796R21DA060345-01A1
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

tobacco smoking; chronic pain

Outcome Measures

Primary Outcomes (3)

• Recruitment Feasibility

  Enroll \>80% or more of people who meet eligibility criteria.

  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.

  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.

  Immediately post intervention (at the end of the intervention session).

Secondary Outcomes (5)

• Cessation Motivation

  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

  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

  2-week, 1-month, 3-month follow-up

• Pain and Smoking Inventory

  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

  Assessed immediately before and after the intervention (during the interventions session), and at 2-weeks, 1-month, and 3-months after the intervention session

Study Arms (2)

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

Interventions

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 Intervention 1

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.

Smoking and Health Intervention 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Binghamton University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Binghamton University

Binghamton, New York, 13905, United States

RECRUITING

MeSH Terms

Conditions

Tobacco Smoking; Chronic Pain

Interventions

Smoking Devices

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

Emily Zale

CONTACT

607-777-3381; ezale@binghamton.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 24, 2026
• First Posted: August 4, 2026
• Study Start: December 19, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: August 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Access Criteria: Individuals will request access to the data via a data access request through the data archive.

Locations

US (1)