CompletedNCT02971137PASSUpdated Jul 28, 2023Results posted

Pain and Smoking Study

An interventional study of Smoking Cessation plus CBI and Smoking Cessation Standard in Smoking, Pain and Smoking Cessation, sponsored by VA Office of Research and Development. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-28.

Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 371
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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 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 studied

Smoking
Pain
Smoking Cessation

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Keywords

Smoking
Cigarette Smoking
Veterans
Tobacco Use
Pain

In context

Smoking

325 studies on the registry are indexed under Smoking; 141 are open to participants now.

This study's enrollment of 371 is above the median of 117 across 250 interventional studies indexed under Smoking.

Browse Smoking studies →

Lead sponsor

VA Office of Research and Development is the lead sponsor of 1,767 studies on the registry; 394 are open to participants now.

Of its 209 completed or terminated interventional studies of FDA-regulated products, 183 (88%) have results posted.

Browse VA Office of Research and Development studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 371 participants (actual)

Study arms

Experimental
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
Behavioral: Smoking Cessation plus CBI
Active comparator
Smoking Cessation Standard (SMK-STD)
A contact-equivalent control that provides standard smoking cessation telephone counseling
Behavioral: Smoking Cessation Standard

Interventions

BehavioralSmoking Cessation plus CBI
proactive tele-health intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain
Also known as: SMK-CBI
BehavioralSmoking Cessation Standard
standard telephone-based smoking cessation intervention
Also known as: SMK-STD

What researchers measure

Primary outcomes

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?
Time frame: 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?
Time frame: 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?
Time frame: 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?
Time frame: 12 month post intervention

Secondary outcomes

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.
Time frame: 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.
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
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.
Time frame: 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
Time frame: Baseline to 12-month post intervention

Results

Posted Jan 4, 2023

Limitations and caveats

Total enrollment was increased from 370 to 371 due to simultaneous enrollment of last subjects for study.

Participant flow

Participant flow — Overall Study
Milestone	Smoking Cessation Plus CBI (SMK-CBI)	Smoking Cessation Standard (SMK-STD)
Started	189	182
Completed	145	126
Not completed	44	56
Withdrew: Lost to follow-up	44	56

Outcome measures

PrimaryNumber 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?

Time frame:: 6-month
Reported as:: Count of participants · Participants

Number of Participants Who Abstained From Smoking Cigarettes at 6months (Prolonged Abstinence)
Participants	Smoking Cessation Plus CBI (SMK-CBI)	Smoking Cessation Standard (SMK-STD)
Number of Participants Who Abstained From Smoking Cigarettes at 6months (Prolonged Abstinence)	43	41

PrimaryNumber 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?

Time frame:: 12-month post intervention
Reported as:: Count of participants · Participants

Number of Participants Who Abstained From Smoking Cigarettes at 12 Months (Prolonged Abstinence)
Participants	Smoking Cessation Plus CBI (SMK-CBI)	Smoking Cessation Standard (SMK-STD)
Number of Participants Who Abstained From Smoking Cigarettes at 12 Months (Prolonged Abstinence)	40	38

PrimaryNumber 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?

Time frame:: 6-month post intervention
Reported as:: Count of participants · Participants

Number of Participants Who Abstained From Smoking Part of a Cigarette at 6months (30-day Point Prevalence)
Participants	Smoking Cessation Plus CBI (SMK-CBI)	Smoking Cessation Standard (SMK-STD)
Number of Participants Who Abstained From Smoking Part of a Cigarette at 6months (30-day Point Prevalence)	23	11

PrimaryNumber 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?

Time frame:: 12 month post intervention
Reported as:: Count of participants · Participants

Number of Participants Who Abstained From Smoking Part of a Cigarette at 12 Months (30-day Point Prevalence)
Participants	Smoking Cessation Plus CBI (SMK-CBI)	Smoking Cessation Standard (SMK-STD)
Number of Participants Who Abstained From Smoking Part of a Cigarette at 12 Months (30-day Point Prevalence)	25	18

SecondaryChange 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.

Time frame:: Baseline to 6-month post intervention
Reported as:: Mean · score on a scale

Change in Brief Pain Inventory (BPI) Pain Intensity, Difference From Baseline to Follow-up at 6 Months
score on a scale	Smoking Cessation Plus CBI (SMK-CBI)	Smoking Cessation Standard (SMK-STD)
Change in Brief Pain Inventory (BPI) Pain Intensity, Difference From Baseline to Follow-up at 6 Months	-0.7 ± 1.7	-0.5 ± 1.8

SecondaryChange 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.

Time frame:: Baseline to 6-month post intervention
Reported as:: Mean · score on a scale

Change in Pain Interference, Difference Between Baseline and Follow-up at 6 Months
score on a scale	Smoking Cessation Plus CBI (SMK-CBI)	Smoking Cessation Standard (SMK-STD)
Change in Pain Interference, Difference Between Baseline and Follow-up at 6 Months	-0.72 ± 2.4	-0.36 ± 2.2

SecondaryChange in Brief Pain Inventory (BPI) Pain Intensity, Difference in Pain Intensity Between Baseline and 12 Months

Time frame:: Baseline to 12-month post-intervention
Reported as:: Mean · score on a scale

Change in Brief Pain Inventory (BPI) Pain Intensity, Difference in Pain Intensity Between Baseline and 12 Months
score on a scale	Smoking Cessation Plus CBI (SMK-CBI)	Smoking Cessation Standard (SMK-STD)
Change in Brief Pain Inventory (BPI) Pain Intensity, Difference in Pain Intensity Between Baseline and 12 Months	-.044 ± 1.6	-0.35 ± 1.7

SecondaryChange in Pain Interference, Difference Between Baseline and Interference

Time frame:: Baseline to 12-month post intervention
Reported as:: Mean · score on a scale

Change in Pain Interference, Difference Between Baseline and Interference
score on a scale	Smoking Cessation Plus CBI (SMK-CBI)	Smoking Cessation Standard (SMK-STD)
Change in Pain Interference, Difference Between Baseline and Interference	-.56 ± 2.3	-.46 ± 2.1

Adverse events

Collected over Participants were followed for AE data through duration of their 5 counseling sessions time frame around 3 months.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Smoking Cessation Plus CBI (SMK-CBI)	0/189 (0%)	0/189 (0%)	0/189 (0%)
Smoking Cessation Standard (SMK-STD)	0/182 (0%)	0/182 (0%)	0/182 (0%)

Baseline characteristics

Veteran population who smoked at least 4 cigarettes a week and pain intesity scores \>4 for at least 3 months

Age, Categorical
Age, Categorical(Participants)	Smoking Cessation Plus CBI (SMK-CBI)	Smoking Cessation Standard (SMK-STD)	Total
<=18 years	0	0	0
Between 18 and 65 years	133	130	263
>=65 years	56	52	108

Age, Continuous
Age, Continuous(Years)	Smoking Cessation Plus CBI (SMK-CBI)	Smoking Cessation Standard (SMK-STD)	Total
Median	60 (46 to 65)	60 (53 to 65)	60 (52 to 65)

Sex: Female, Male
Sex: Female, Male(Participants)	Smoking Cessation Plus CBI (SMK-CBI)	Smoking Cessation Standard (SMK-STD)	Total
Female	18	26	44
Male	171	156	327

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Smoking Cessation Plus CBI (SMK-CBI)	Smoking Cessation Standard (SMK-STD)	Total
Hispanic or Latino	9	16	25
Not Hispanic or Latino	179	165	344
Unknown or Not Reported	1	1	2

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Smoking Cessation Plus CBI (SMK-CBI)	Smoking Cessation Standard (SMK-STD)	Total
American Indian or Alaska Native	1	0	1
Asian	0	2	2
Native Hawaiian or Other Pacific Islander	1	0	1
Black or African American	50	47	97
White	123	112	235
More than one race	7	7	14
Unknown or Not Reported	7	14	21

Region of Enrollment
Region of Enrollment(Participants)	Smoking Cessation Plus CBI (SMK-CBI)	Smoking Cessation Standard (SMK-STD)	Total
United States	189	182	371

Study locations

2 sites

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

References and documents

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 ↗

Study documents

Protocol and statistical analysis plan · Sep 1, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2017 to primary completion in Oct 2021, 46 months.

Results were first posted in Jan 2023, 1 year 2 months after primary completion.

Of 141 non-industry interventional studies with no phase under Smoking, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 60. This study's 46 months is above that.

Counting every sponsor, half of 155 studies reached it within 37 months; a quarter within 18 and three quarters within 59.

How these figures are worked out, and which studies are left out of them.

Registered: Nov 16, 2016
First posted: Nov 22, 2016
StartActual: Dec 22, 2017
Primary completionActual: Oct 30, 2021
CompletionActual: Jan 31, 2022
Results first posted: Jan 4, 2023
Last update: Jul 28, 2023

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jul 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02971137
Lead sponsor: VA Office of Research and Development
Responsible party: Sponsor
First posted: Nov 22, 2016
Start date: Dec 22, 2017
Primary completion: Oct 30, 2021
Completion: Jan 31, 2022
Results posted: Jan 4, 2023
Last update: Jul 28, 2023

Study contacts

Lori Anne Bastian, MD MPH

principal investigator · VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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