SmokingPASS2NCT06442514
Pain and Smoking Study 2.0: A Randomized Clinical Trial of Smoking Cessation Among Veterans With Chronic Pain
A study testing PASS2 and Treatment as Usual in people with Smoking and Pain, run by VA Office of Research and Development at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking, Pain, Smoking Cessation
- What is being tested?
- PASS2 and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2026to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- pregnancy
- provider advising against exercise
- planned surgeries
- clinically significant depressive symptoms (>10 PHQ-9)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, 06516-2770
Lori A Bastian, MD MPH, (203) 932-5711 ext. 3830, Lori.Bastian@va.gov
Lori Anne Bastian, MD MPH
About this study
Official title: Enhancing an Intervention for Smokers With Chronic Pain Using IVR: A Randomized Clinical Trial of Smoking Cessation Counseling for Veterans
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.
Read the detailed description
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:
- Determine whether the existing integrated pain and smoking cessation (PASS intervention) augmented with nightly surveys (PASS2) is superior to treatment as usual (e.g., referral to standard VA smoking cessation clinic) enhanced with pharmacotherapy tele-consult (E-TAU) at 4 months and 10 months (primary endpoint) on cigarette abstinence rates among non-depressed Veterans with chronic pain.
- Determine whether PASS2 is superior to E-TAU at 4 months and 10 months (primary endpoint) on pain interference.
- Examine critical components of the intervention process to inform future program implementation.
- Conditions
- Smoking, Pain, Smoking Cessation
- Being tested
- PASS2, Treatment as Usual
- Medical subject headings
- Smoking, Pain, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PASS2Behavioural
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 UsualOther
Referral to the local smoking cessation VA clinic.
| Study group | Role | What they receive |
|---|---|---|
| PASS2 | Experimental | 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). Receives: Behavioral: PASS2 |
| Treatment as Usual | Other | 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 Receives: Other: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?"
Measured: 10-month follow-up
Secondary outcomes (3)
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?"
Measured: 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?"
Measured: 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.
Measured: 4-month and 10-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start21 Sep 2026
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Lori Anne Bastian, MD MPH, Principal investigator, VA Connecticut Healthcare System West Haven Campus, West Haven, CT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06442514
- Sponsor's protocol ID
- IIR 22-070
- Other IDs
- 5I01HX003607
- Acronym
- PASS2
- Status last verified
- Sep 2026
- First submitted
- 29 May 2024
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing an Intervention for Smokers With Chronic Pain Using IVR: A Randomized Clinical Trial of Smoking Cessation Counseling for Veterans
- ClinicalTrials.gov ID
- NCT06442514
- Acronym / sponsor ID
- PASS2 / IIR 22-070
- Conditions
- Smoking, Pain, Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 21 Sep 2026 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Determine whether the existing integrated pain and smoking cessation (PASS intervention) augmented with nightly surveys (PASS2) is superior to treatment as usual (e.g., referral to standard VA smoking cessation clinic) enhanced with pharmacotherapy tele-consult (E-TAU) at 4 months and 10 months (primary endpoint) on cigarette abstinence rates among non-depressed Veterans with chronic pain.
- Determine whether PASS2 is superior to E-TAU at 4 months and 10 months (primary endpoint) on pain interference.
- Examine critical components of the intervention process to inform future program implementation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PASS2 | Experimental | Behavioral: PASS2An 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). |
| Treatment as Usual | Other | Other: Treatment as UsualTreatment 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PASS2An 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. | Behavioural | PASS2 |
| Treatment as UsualReferral to the local smoking cessation VA clinic. | Other | Treatment as Usual |
Primary outcome
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?"
3 secondary outcomes
Cigarette Smoking Abstinence Rates
Time frame: 4-month follow up
Point prevalent abstinence
Time frame: 4-month and 10-month follow-up
Pain intensity and pain-related functional interference
Time frame: 4-month and 10-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lori Anne Bastian, MD MPH principal investigator
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PASS2 and Treatment as Usual in people with Smoking and Pain, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lori A Bastian, MD MPH ((203) 932-5711 ext. 3830, Lori.Bastian@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cigarette Smoking Abstinence Rates (time frame: 10-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.