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Not yet recruiting NCT06442514

Pain and Smoking Study 2

No phase Interventional Smoking Pain Smoking Cessation

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: PASS2, Treatment as Usual.
Who it may be relevant to
Registry conditions: Smoking, Pain, Smoking Cessation. 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 →

Official title

Enhancing an Intervention for Smokers With Chronic Pain Using IVR: A Randomized Clinical Trial of Smoking Cessation Counseling for Veterans

Overview

PASS2 aims to expand upon the recently completed study (PASS intervention), which tested the telephone delivery of a cognitive behavioral intervention (CBI). This study will use nightly surveys to optimize the intervention's effectiveness for smoking cessation among Veteran smokers with chronic pain.

Detailed description

Veterans with chronic pain represent an important population in which to focus smoking cessation efforts. Smoking cessation among patients with chronic medical illnesses substantially decreases morbidity and mortality; yet, many patients (\>50%) with chronic pain continue to smoke.

This study aims to:

1. Determine whether the existing integrated pain and smoking cessation (PASS intervention) augmented with nightly surveys (PASS2) is superior to treatment as usual (e.g., referral to standard VA smoking cessation clinic) enhanced with pharmacotherapy tele-consult (E-TAU) at 4 months and 10 months (primary endpoint) on cigarette abstinence rates among non-depressed Veterans with chronic pain. 2. Determine whether PASS2 is superior to E-TAU at 4 months and 10 months (primary endpoint) on pain interference. 3. Examine critical components of the intervention process to inform future program implementation.

Interventions

  • Behavioral PASS2
    An intervention that includes a proactive telehealth intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain, and nightly surveys to report smoking status, pain, and pedometer-measured step counts, which the clinician will use to provide individualized feedback.
  • Other Treatment as Usual
    Referral to the local smoking cessation VA clinic.

Primary outcome measures

  • Cigarette Smoking Abstinence Rates [Time frame: 10-month follow-up]
Secondary outcome measures (3)
  • Cigarette Smoking Abstinence Rates [Time frame: 4-month follow up]
  • Point prevalent abstinence [Time frame: 4-month and 10-month follow-up]
  • Pain intensity and pain-related functional interference [Time frame: 4-month and 10-month follow-up]

Eligibility criteria

Inclusion criteria

  • being an enrolled Veteran at VACHS
  • current tobacco use
  • willingness to make a quit attempt
  • significant chronic pain defined as >/=4 on the pain intensity portion of the Brief Pain Inventory (BPI) for more than 90 days

Exclusion criteria

  • active diagnosis of dementia or psychosis in medical record
  • severely impaired hearing or speech
  • lack of telephone access
  • enrollment in concurrent research study that might affect main outcomes of this study
  • terminal illness
  • non-English speaking
  • pregnancy
  • provider advising against exercise
  • planned surgeries
  • clinically significant depressive symptoms (>10 PHQ-9)

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
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • VA Connecticut Healthcare System West Haven Campus, West Haven, CT — West Haven

Identifiers

NCT: NCT06442514 · IIR 22-070

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗