NCT06442514 · VA Office of Research and Development
Pain and Smoking Study 2.0: A Randomized Clinical Trial of Smoking Cessation Among Veterans With Chronic Pain
(PASS2)
What this study is about
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.
View original scientific description
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.
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
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?"
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- provider advising against exercise
- planned surgeries
- clinically significant depressive symptoms (\>10 PHQ-9)
Where
- West Haven, Connecticut
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 29, 2026 · Source of record for eligibility and locations