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Recruiting NCT07743710

The SMOKE Telehealth Study

No phase Interventional Tobacco Smoking

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Smoking and Health Telehealth Intervention 1, Smoking and Health Telehealth Intervention 2.
Who it may be relevant to
Registry conditions: Tobacco Smoking. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Behavioral Smoking and Health Telehealth Intervention 1
    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.
  • Behavioral Smoking and Health Telehealth Intervention 2
    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 outcome measures

  • 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.]
  • 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.]
  • Acceptability [Time frame: Immediately post intervention (at the end of the intervention session).]
Secondary outcome measures (5)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Binghamton University — Binghamton

Identifiers

NCT: NCT07743710 · STUDY00005796 · R21DA060345-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗