SmokingPASSNCT02971137

Pain and Smoking Study

A study testing Smoking Cessation plus CBI and Smoking Cessation Standard in people with Smoking and Pain, run by VA Office of Research and Development at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This purpose of this study is to test the telephone delivery of a cognitive behavioral intervention (CBI), 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?: Smoking Cessation plus CBI and Smoking Cessation Standard
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 371 participants
Where: 2 sitesUnited States
Study dates: 22 Dec 2017to 31 Jan 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Veterans enrolled at VA Connecticut or VA Central Western Massachusetts
Current Cigarette Smokers
Willing to make quit attempt in next 30 days
Pain intensity 4 or greater on scale 0-10, self-reported

Who cannot join

Non-English speaking
No access to telephone/Lack of Telephone Access
Severely impaired hearing
Active diagnosis
Terminal Illness
Refusal to provide informed consent
Enrolled in concurrent smoking cessation programs/research

Trial locations and contacts

2 sites in 1 country.

United States2 sites

VA Central Western Massachusetts Healthcare System, Leeds, MA
Leeds, Massachusetts, 01053-9764
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, 06516-2770

Other trials in United States

About this study

Official title: Pain-related Anxiety Intervention for Smokers With Chronic Pain: A Comparative Effectiveness Trial of Smoking Cessation Counseling for Veterans

This purpose of this study is to test the telephone delivery of a cognitive behavioral intervention (CBI), 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 test the telephone delivery of a cognitive behavioral intervention (CBI), for smoking cessation among Veteran smokers with chronic pain. Proposed is a randomized comparative effectiveness trial with a two-group design in which 370 Veteran smokers with chronic pain will be randomized to either: 1) smoking cessation plus CBI (SMK-CBI), an intervention that includes a proactive tele-health intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain and a tele-medicine clinic for accessing nicotine replacement therapy (NRT), or 2) smoking cessation telephone counseling control (SMK Control), a contact-equivalent control that provides standard smoking cessation telephone counseling and a tele-medicine clinic for accessing NRT.

Conditions: Smoking, Pain, Smoking Cessation
Being tested: Smoking Cessation plus CBI, Smoking Cessation Standard
Keywords: Smoking, Cigarette Smoking, Veterans, Tobacco Use, Pain
Medical subject headings: Smoking, Pain, Smoking Cessation, Cigarette Smoking, Tobacco Use

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Smoking Cessation plus CBIBehavioural
Also called SMK-CBI
proactive tele-health intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain
Smoking Cessation StandardBehavioural
Also called SMK-STD
standard telephone-based smoking cessation intervention

Study groups in NCT02971137
Study group	Role	What they receive
Smoking Cessation plus CBI (SMK-CBI)	Experimental	An intervention that includes a proactive tele-health intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain Receives: Behavioral: Smoking Cessation plus CBI
Smoking Cessation Standard (SMK-STD)	Active comparator	A contact-equivalent control that provides standard smoking cessation telephone counseling Receives: Behavioral: Smoking Cessation Standard

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants Who Abstained From Smoking Cigarettes at 6months (Prolonged Abstinence)
In the past 6 months, have he/she smoked any in each of 2 consecutive weeks?
Measured: 6-month
Number of Participants Who Abstained From Smoking Cigarettes at 12 Months (Prolonged Abstinence)
In the past 6 months, have he/she smoked any in each of 2 consecutive weeks?
Measured: 12-month post intervention
Number of Participants Who Abstained From Smoking Part of a Cigarette at 6months (30-day Point Prevalence)
30-day point prevalence abstinence rates, Have he/she smoked at least part of a cigarette in last 30 days?
Measured: 6-month post intervention
Number of Participants Who Abstained From Smoking Part of a Cigarette at 12 Months (30-day Point Prevalence)
30-day point prevalence abstinence rates, have he/she smoked at least part of a cigarette in last 30 days?
Measured: 12 month post intervention

Secondary outcomes (4)

Change in Brief Pain Inventory (BPI) Pain Intensity, Difference From Baseline to Follow-up at 6 Months
BPI Pain Intensity takes the mean of 4 self-reported numeric rating scale questions about one's pain: worst, least, current, and average pain. Rate pain on a 0 (no pain) to 10 (worst pain imaginable) scale. Veterans will be asked at baseline and after intervention. We are showing the change from baseline to follow-up, a negative score means the pain intensity has decreased.
Measured: Baseline to 6-month post intervention
Change in Pain Interference, Difference Between Baseline and Follow-up at 6 Months
Pain interference will be measured by the Brief Pain Inventory (BPI). Veterans will be asked at baseline and after intervention. How does pain interfere on a 0 (no interference) to 10 (completely interferes) scale on 7 different facets of living. The total is the mean of all 7 questions. Veterans will be asked at baseline and after intervention. We are showing the change from baseline to follow-up, a negative score means the pain interference has decreased.
Measured: Baseline to 6-month post intervention
Change in Brief Pain Inventory (BPI) Pain Intensity, Difference in Pain Intensity Between Baseline and 12 Months
BPI Pain Intensity takes the mean of 4 self-reported numeric rating scale questions about one's pain: worst, least, current, and average pain. Rate pain on a 0 (no pain) to 10 (worst pain imaginable) scale. Veterans will be asked at baseline and after intervention. We are showing the change from baseline to follow-up, a negative score means the pain intensity has decreased.
Measured: Baseline to 12-month post-intervention
Change in Pain Interference, Difference Between Baseline and Interference
Pain interference will be measured by the Brief Pain Inventory (BPI). Veterans will be asked at baseline and after intervention. How does pain interfere on a 0 (no interference) to 10 (completely interferes) scale on 7 different facets of living. The total is the mean of all 7 questions. Veterans will be asked at baseline and after intervention. We are showing the change from baseline to follow-up, a negative score means the pain interference has decreased
Measured: Baseline to 12-month post intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Dec 201731 Jan 2022

First posted22 Nov 2016 (estimated)
Study start22 Dec 2017
Primary completion30 Oct 2021
Study completion31 Jan 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
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: None (open label)
Enrolment: 371 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02971137
Sponsor's protocol ID: IIR 15-092
Acronym: PASS
Status last verified: Jul 2023
First submitted: 16 Nov 2016
Last updated: 28 Jul 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Green KT, Wilson SM, Dennis PA, Runnals JJ, Williams RA, Bastian LA, Beckham JC, Dedert EA, Kudler HS, Straits-Troster K, Gierisch JM, Calhoun PS. Cigarette Smoking and Musculoskeletal Pain Severity Among Male and Female Afghanistan/Iraq Era Veterans. Pain Med. 2017 Sep 1;18(9):1795-1804. doi: 10.1093/pm/pnw339.
PubMed 28340108
Charokopos A, Card ME, Gunderson C, Steffens C, Bastian LA. The Association of Obstructive Sleep Apnea and Pain Outcomes in Adults: A Systematic Review. Pain Med. 2018 Sep 1;19(suppl_1):S69-S75. doi: 10.1093/pm/pny140.
PubMed 30203008
Bastian LA, Driscoll M, DeRycke E, Edmond S, Mattocks K, Goulet J, Kerns RD, Lawless M, Quon C, Selander K, Snow J, Casares J, Lee M, Brandt C, Ditre J, Becker W. Pain and smoking study (PASS): A comparative effectiveness trial of smoking cessation counseling for veterans with chronic pain. Contemp Clin Trials Commun. 2021 Aug 20;23:100839. doi: 10.1016/j.conctc.2021.100839. eCollection 2021 Sep.
PubMed 34485755
Edmond SN, Snow JL, Pomeranz J, Van Cleve R, Black AC, Compton P, Becker WC. Delphi study to explore a new diagnosis for "ineffective" long-term opioid therapy for chronic pain. Pain. 2023 Apr 1;164(4):870-876. doi: 10.1097/j.pain.0000000000002783. Epub 2022 Sep 15.
PubMed 36448976
Bastian LA, Driscoll MA, Goulet JL, DeRycke EC, Edmond SN, Mattocks KM, Brandt CA, Kravetz J, Akuley SA, Becker WC. Smoking Cessation Among Patients with Chronic Pain in a Comparative Effectiveness Trial. J Gen Intern Med. 2025 Dec 18. doi: 10.1007/s11606-025-10083-x. Online ahead of print.
PubMed 41413292
Muller RD, Driscoll MA, DeRycke EC, Edmond SN, Becker WC, Bastian LA. Factors associated with participation in a walking intervention for veterans who smoke and have chronic pain. J Behav Med. 2024 Dec;47(6):994-1001. doi: 10.1007/s10865-024-00511-4. Epub 2024 Aug 14.
PubMed 39143444

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pain-related Anxiety Intervention for Smokers With Chronic Pain: A Comparative Effectiveness Trial of Smoking Cessation Counseling for Veterans
ClinicalTrials.gov ID: NCT02971137
Acronym / sponsor ID: PASS / IIR 15-092
Conditions: Smoking, Pain, Smoking Cessation
Keywords: Smoking, Cigarette Smoking, Veterans, Tobacco Use, Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 371 participants (actual)
Lead sponsor: VA Office of Research and DevelopmentUS federal agency
Study start: 22 Dec 2017 (actual)
Primary completion: 30 Oct 2021 (actual)
Study completion: 31 Jan 2022 (actual)
First posted: 22 Nov 2016 (estimated)
Results: Posted 4 Jan 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This purpose of this study is to test the telephone delivery of a cognitive behavioral intervention (CBI), for smoking cessation among Veteran smokers with chronic pain

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Smoking Cessation plus CBI (SMK-CBI)	Experimental	Behavioral: Smoking Cessation plus CBIAn intervention that includes a proactive tele-health intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain
Smoking Cessation Standard (SMK-STD)	Active comparator	Behavioral: Smoking Cessation StandardA contact-equivalent control that provides standard smoking cessation telephone counseling

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Veterans enrolled at VA Connecticut or VA Central Western Massachusetts
Current Cigarette Smokers
Willing to make quit attempt in next 30 days
Pain intensity 4 or greater on scale 0-10, self-reported

Key exclusion criteria (7 listed)

Non-English speaking
No access to telephone/Lack of Telephone Access
Severely impaired hearing
Active diagnosis
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
Smoking Cessation plus CBIAlso: SMK-CBIproactive tele-health intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain	Behavioural	Smoking Cessation plus CBI (SMK-CBI)
Smoking Cessation StandardAlso: SMK-STDstandard telephone-based smoking cessation intervention	Behavioural	Smoking Cessation Standard (SMK-STD)

Primary outcome

Number of Participants Who Abstained From Smoking Cigarettes at 6months (Prolonged Abstinence)
Time frame: 6-month
In the past 6 months, have he/she smoked any in each of 2 consecutive weeks?
Number of Participants Who Abstained From Smoking Cigarettes at 12 Months (Prolonged Abstinence)
Time frame: 12-month post intervention
In the past 6 months, have he/she smoked any in each of 2 consecutive weeks?
Number of Participants Who Abstained From Smoking Part of a Cigarette at 6months (30-day Point Prevalence)
Time frame: 6-month post intervention
30-day point prevalence abstinence rates, Have he/she smoked at least part of a cigarette in last 30 days?
Number of Participants Who Abstained From Smoking Part of a Cigarette at 12 Months (30-day Point Prevalence)
Time frame: 12 month post intervention
30-day point prevalence abstinence rates, have he/she smoked at least part of a cigarette in last 30 days?

4 secondary outcomes

Change in Brief Pain Inventory (BPI) Pain Intensity, Difference From Baseline to Follow-up at 6 Months
Time frame: Baseline to 6-month post intervention
Change in Pain Interference, Difference Between Baseline and Follow-up at 6 Months
Time frame: Baseline to 6-month post intervention
Change in Brief Pain Inventory (BPI) Pain Intensity, Difference in Pain Intensity Between Baseline and 12 Months
Time frame: Baseline to 12-month post-intervention
Change in Pain Interference, Difference Between Baseline and Interference
Time frame: Baseline to 12-month post intervention

Results and safety

Results posted to the registry on 4 Jan 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Smoking Cessation Plus CBI (SMK-CBI)	189	145
Smoking Cessation Standard (SMK-STD)	182	126

Primary outcome: Number of Participants Who Abstained From Smoking Cigarettes at 6months (Prolonged Abstinence)

Time frame: 6-month. Count of participants. Unit: Participants

Measure	Smoking Cessation Plus CBI (SMK-CBI) n = 189	Smoking Cessation Standard (SMK-STD) n = 182
Value	43	41

Population analysed: Veteran population who smoked at least 4 cigarettes a week and pain intensity scores \>4 for at least 3 months. There were 227/371 6m responders, non-responders were assumed to continue smoking

Primary outcome: Number of Participants Who Abstained From Smoking Cigarettes at 12 Months (Prolonged Abstinence)

Time frame: 12-month post intervention. Count of participants. Unit: Participants

Measure	Smoking Cessation Plus CBI (SMK-CBI) n = 189	Smoking Cessation Standard (SMK-STD) n = 182
Value	40	38

Population analysed: Veteran population who smoked at least 4 cigarettes a week and pain intensity scores \>4 for at least 3 months. There were 271/371 12m responders, non-responders were assumed to continue smoking

Primary outcome: Number of Participants Who Abstained From Smoking Part of a Cigarette at 6months (30-day Point Prevalence)

Time frame: 6-month post intervention. Count of participants. Unit: Participants

Measure	Smoking Cessation Plus CBI (SMK-CBI) n = 189	Smoking Cessation Standard (SMK-STD) n = 182
Value	23	11

Population analysed: There were 227/371 6m responders, no responders were assumed to continue smoking

Primary outcome: Number of Participants Who Abstained From Smoking Part of a Cigarette at 12 Months (30-day Point Prevalence)

Time frame: 12 month post intervention. Count of participants. Unit: Participants

Measure	Smoking Cessation Plus CBI (SMK-CBI) n = 189	Smoking Cessation Standard (SMK-STD) n = 182
Value	25	18

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Participants were followed for AE data through duration of their 5 counseling sessions time frame around 3 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Smoking Cessation Plus CBI (SMK-CBI)	0 of 189 (0%)	0 of 189 (0%)	0 of 189
Smoking Cessation Standard (SMK-STD)	0 of 182 (0%)	0 of 182 (0%)	0 of 182

Limitations and caveats (from the sponsor): Total enrollment was increased from 370 to 371 due to simultaneous enrollment of last subjects for study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 28340108Green KT, Wilson SM, Dennis PA, Runnals JJ, Williams RA, Bastian LA, Beckham JC, Dedert EA, Kudler HS, Straits-Troster K, Gierisch JM, Calhoun PS. Cigarette Smoking and Musculoskeletal Pain Severity Among Male and Female Afghanistan/Iraq Era Veterans. Pain Med. 2017 Sep 1;18(9):1795-1804. doi: 10.1093/pm/pnw339.
Results publication: PubMed 30203008Charokopos A, Card ME, Gunderson C, Steffens C, Bastian LA. The Association of Obstructive Sleep Apnea and Pain Outcomes in Adults: A Systematic Review. Pain Med. 2018 Sep 1;19(suppl_1):S69-S75. doi: 10.1093/pm/pny140.
Results publication: PubMed 34485755Bastian LA, Driscoll M, DeRycke E, Edmond S, Mattocks K, Goulet J, Kerns RD, Lawless M, Quon C, Selander K, Snow J, Casares J, Lee M, Brandt C, Ditre J, Becker W. Pain and smoking study (PASS): A comparative effectiveness trial of smoking cessation counseling for veterans with chronic pain. Contemp Clin Trials Commun. 2021 Aug 20;23:100839. doi: 10.1016/j.conctc.2021.100839. eCollection 2021 Sep.
Results publication: PubMed 36448976Edmond SN, Snow JL, Pomeranz J, Van Cleve R, Black AC, Compton P, Becker WC. Delphi study to explore a new diagnosis for "ineffective" long-term opioid therapy for chronic pain. Pain. 2023 Apr 1;164(4):870-876. doi: 10.1097/j.pain.0000000000002783. Epub 2022 Sep 15.
Derived from this study: PubMed 41413292Bastian LA, Driscoll MA, Goulet JL, DeRycke EC, Edmond SN, Mattocks KM, Brandt CA, Kravetz J, Akuley SA, Becker WC. Smoking Cessation Among Patients with Chronic Pain in a Comparative Effectiveness Trial. J Gen Intern Med. 2025 Dec 18. doi: 10.1007/s11606-025-10083-x. Online ahead of print.
Derived from this study: PubMed 39143444Muller RD, Driscoll MA, DeRycke EC, Edmond SN, Becker WC, Bastian LA. Factors associated with participation in a walking intervention for veterans who smoke and have chronic pain. J Behav Med. 2024 Dec;47(6):994-1001. doi: 10.1007/s10865-024-00511-4. Epub 2024 Aug 14.
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. This study is not recruiting at the moment.

Lori Anne Bastian, MD MPH principal investigator

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Smoking Cessation plus CBI and Smoking Cessation Standard in people with Smoking and Pain, run by VA Office of Research and Development at 2 sites 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 7 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: finished, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Yes. Results are posted in the registry (first posted 4 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Abstained From Smoking Cigarettes at 6months (Prolonged Abstinence) (time frame: 6-month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02971137, which also lists 6 linked publications.

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 28 Jul 2023.