Pain and Smoking Study 2.0: A Randomized Clinical Trial of Smoking Cessation Among Veterans With Chronic Pain

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • PASS2

    Behavioral

    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.

  • Treatment as Usual

    Other intervention

    Referral to the local smoking cessation VA clinic.

Treatment groups

220 Participants
are divided into 2 treatment groups
Group A: PASS2Experimental treatment 1 intervention
Group B: Treatment as UsualOther 1 intervention

Trial outcomes

Primary outcomes

1

Cigarette Smoking Abstinence Rates

In keeping with the sinus node recovery time (SNRT) recommendations for measuring abstinence, the investigators will use prolonged abstinence as our main outcome. During the 10-month follow-ups, patients will be asked about prolonged abstinence, "In the past 6 months, have you smoked a cigarette, even a puff?"

Time frame
10-month follow-up

Secondary outcomes

1

Cigarette Smoking Abstinence Rates

The investigators will measure prolonged abstinence at the 4-month follow up as a secondary outcome. During the 4-month follow-ups, patients will be asked about prolonged abstinence, "In the past 3 months have you smoked a cigarette, even a puff?"

Time frame
4-month follow up
2

Point prevalent abstinence

Patients will be asked "Have you have smoked at least part of a cigarette, even a puff, in the past 7 days?"

Time frame
4-month and 10-month follow-up
3

Pain intensity and pain-related functional interference

Pain intensity and interference will be assessed using the 11-item Brief Pain Inventory (BPI). The BPI also assesses chronicity of pain and areas of the body with pain. The interference subscale has demonstrated adequate internal consistency and robust concurrent validity and responsivity among patients with chronic non-cancer pain. The investigators have also added the PROMIS 8-item pain interference measure and the PROMIS 3-item pain intensity measure which has comparable responsiveness to BPI and excellent internal consistency.

Time frame
4-month and 10-month follow-up

Other outcomes

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