An interventional study of PASS2 and Treatment as Usual in Smoking, Pain and Smoking Cessation, sponsored by VA Office of Research and Development. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
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.
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:
1,509 studies on the registry are indexed under Smoking; 193 are open to participants now.
This study's planned enrollment of 220 is above the median of 115 across 1,164 interventional studies indexed under Smoking.
Browse Smoking studies →VA Office of Research and Development is the lead sponsor of 1,771 studies on the registry; 392 are open to participants now.
Of its 213 completed or terminated interventional studies of FDA-regulated products, 185 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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. Veterans in PASS2 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).
Behavioral: PASS2
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
Other: Treatment as Usual
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.
Referral to the local smoking cessation VA clinic.
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
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
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
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
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2026 (actual). Primary completion is estimated for May 2028, 20 months after the start.
Of 401 non-industry interventional studies with no phase under Smoking, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 42. This study's planned 20 months is below that.
Counting every sponsor, half of 456 studies reached it within 23 months; a quarter within 8 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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