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Behavioral Intervention

IVR Therapy for Smoking Cessation and Pain (PASS-IVR Trial)

N/A
Waitlist Available
Led By Lori Anne Bastian, MD MPH
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Significant chronic pain defined as >/=4 on the pain intensity portion of the Brief Pain Inventory (BPI) for more than 90 days.
Be older than 18 years old
Must not have
Non-English speaking
Severely impaired hearing or speech
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-month and 12-month follow-up
Awards & highlights
No Placebo-Only Group

Summary

"This trial, PASS2, will build on a previous study by using phone calls to deliver a therapy called cognitive behavioral intervention. It will focus on helping Veteran smokers with chronic pain to quit smoking more effectively

Who is the study for?
This trial is for Veteran smokers who experience chronic pain and are interested in quitting smoking. Participants should be willing to receive telephone-based support.
What is being tested?
The study tests a phone-delivered cognitive behavioral intervention (CBI) using Interactive Voice Response (IVR) to help Veterans quit smoking, comparing it with the usual treatment methods.
What are the potential side effects?
Since this is a behavioral intervention focused on counseling via phone, there are no direct medical side effects like those seen with medications or surgeries.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had significant pain for more than 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not speak English.
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I have severe hearing or speech impairments.
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I am experiencing significant depression symptoms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-month and 12-month follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-month and 12-month follow-up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Cigarette Smoking Abstinence Rates
Secondary study objectives
Pain intensity and pain-related functional interference
Point prevalent abstinence

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Treatment as UsualExperimental Treatment1 Intervention
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
Group II: PASS-IVRExperimental Treatment1 Intervention
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).

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Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,658 Previous Clinical Trials
3,361,542 Total Patients Enrolled
10 Trials studying Smoking
3,405 Patients Enrolled for Smoking
Lori Anne Bastian, MD MPHPrincipal InvestigatorVA Connecticut Healthcare System West Haven Campus, West Haven, CT
2 Previous Clinical Trials
842 Total Patients Enrolled
1 Trials studying Smoking
371 Patients Enrolled for Smoking
~147 spots leftby May 2028
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