Pain and Smoking Study - Interactive Voice Response

Part of paid clinical trials in West Haven, Connecticut.

Sponsor
VA Office of Research and Development
Study ID
NCT06442514
Status
Not Yet Recruiting

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Conditions

  • Pain
  • Smoking
  • Smoking Cessation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PASS-IVR — 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 Interactive Voice Response (IVR) calls to report smoking status, pain, and pedometer-measured step counts, which the clinician will use to provide individualized feedback.
  • Treatment as Usual — OTHER
    Referral to the local smoking cessation VA clinic.

Study Details

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 Interactive Voice Response (IVR) to optimize the intervention's effectiveness for smoking cessation among Veteran smokers with chronic pain.

Key Dates

Start date
Jun 1, 2026
Status verified
May 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
220 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: PASS-IVR
    An intervention that includes a proactive telehealth intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain, and nightly Interactive Voice Response (IVR) calls. Veterans in PASS-IVR will also be offered 12-weeks of pharmacotherapy (e.g., NRT patches and one of two rescue methods such as nicotine lozenge or gum or varenicline) via telemedicine consult. The NRT dose and delivery route will be tailored to the number of cigarettes smoked per day (using an established protocol).
  • Other: Treatment as Usual
    Treatment as usual includes referral to the local smoking cessation clinic where Veterans may select a virtual individual or group based cognitive behavioral smoking cessation program with a trained psychology intern, postdoctoral fellow or staff psychologist. In conjunction, Veterans are encouraged but not required, by clinic staff, to connect with the VA Quitline and the VA's Annie text-messaging service to support their quit. Veterans are strongly encouraged to consider pharmacotherapy (e.g., NRT patches and one of two rescue methods such as nicotine lozenge or gum or varenicline). The NRT dose and delivery route will be tailored to the number of cigarettes smoked per day (using an established protocol - interested Veterans will be offered a telemedicine consult for this service

Primary Outcome Measure

Cigarette Smoking Abstinence Rates [ Time Frame: 6-month and 12-month follow-up ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA Connecticut Healthcare System West Haven Campus, West Haven, CTWest HavenConnecticut06516-2770
Lori A Bastian, MD MPH
[email protected]
(203) 932-5711
Lori Anne Bastian, MD MPH (PRINCIPAL_INVESTIGATOR)

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By research site
VA Connecticut Healthcare System West Haven Campus, West Haven, CT· West Haven, CT

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