Health TrialsbyHealthPanel

The SMOKE Telehealth Study

ConditionTobacco Smoking
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBinghamton University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

moderate to severe chronic pain

current daily tobacco smoking

willing and able to complete study components in English

adult (age 18 or over)

Disqualifiers

planning or currently attempting to quit

recent use of cessation treatments or other products to quit smoking

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

78 Participants
are divided into 2 treatment groups
Group A: Smoking and Health Intervention 1Experimental treatment 1 intervention
Group B: Smoking and Health Intervention 2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Recruitment Feasibility

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

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.
2

Intervention Delivery Feasbility

Delivery of the allocated intervention to at least 95% of enrolled participants.

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.
3

Acceptability

Mean scores for each item on the Client Satisfaction Questionnaire (CSQ) of 3 or greater. Mean total CSQ score of 24 or greater.

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

Secondary outcomes

1

Cessation Motivation

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

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
2

Motivation for Cessation Treatment

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

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
3

Cessation Treatment Engagement

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

Time frame
2-week, 1-month, 3-month follow-up
4

Pain and Smoking Inventory

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Binghamton University

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov
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