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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Smoking Cessation Standard (SMK-STD) | Active Comparator | A contact-equivalent control that provides standard smoking cessation telephone counseling |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smoking Cessation plus CBI | Behavioral | proactive tele-health intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain |
| Measure | Description | Time Frame |
|---|---|---|
| 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? | 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? | 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? | 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? | 12 month post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lori Anne Bastian, MD MPH | VA Connecticut Healthcare System West Haven Campus, West Haven, CT | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Connecticut Healthcare System West Haven Campus, West Haven, CT | West Haven | Connecticut | 06516-2770 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28340108 | Result | 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. | |
| 30203008 | Result |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 Smoking Cessation plus CBI: proactive tele-health intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain |
| FG001 | Smoking Cessation Standard (SMK-STD) | A contact-equivalent control that provides standard smoking cessation telephone counseling Smoking Cessation Standard: standard telephone-based smoking cessation intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Veteran population who smoked at least 4 cigarettes a week and pain intesity scores >4 for at least 3 months
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 Smoking Cessation plus CBI: proactive tele-health intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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? | 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 | Posted | Count of Participants | Participants | 6-month |
|
Participants were followed for AE data through duration of their 5 counseling sessions time frame around 3 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 Smoking Cessation plus CBI: proactive tele-health intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain |
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Total enrollment was increased from 370 to 371 due to simultaneous enrollment of last subjects for study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lori A. Bastian | VA Connecticut Healthcare System | 203-932-5711 | 2655 | lori.bastian@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 1, 2018 | Jan 31, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D010146 | Pain |
| D016540 | Smoking Cessation |
| D000073865 | Cigarette Smoking |
| D064424 | Tobacco Use |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Smoking Cessation Standard | Behavioral | standard telephone-based smoking cessation intervention |
|
|
| 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. | 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. | 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 | Baseline to 12-month post intervention |
| VA Central Western Massachusetts Healthcare System, Leeds, MA |
| Leeds |
| Massachusetts |
| 01053-9764 |
| United States |
| 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. |
| 34485755 | Result | 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. |
| 36448976 | Result | 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. |
| 41413292 | Derived | 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. |
| 39143444 | Derived | 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. |
| BG001 | Smoking Cessation Standard (SMK-STD) | A contact-equivalent control that provides standard smoking cessation telephone counseling Smoking Cessation Standard: standard telephone-based smoking cessation intervention |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Smoking Cessation Standard (SMK-STD) | A contact-equivalent control that provides standard smoking cessation telephone counseling Smoking Cessation Standard: standard telephone-based smoking cessation intervention |
|
|
| Primary | 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? | 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 | Posted | Count of Participants | Participants | 12-month post intervention |
|
|
|
| Primary | 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? | There were 227/371 6m responders, no responders were assumed to continue smoking | Posted | Count of Participants | Participants | 6-month post intervention |
|
|
|
| Primary | 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? | 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 | Posted | Count of Participants | Participants | 12 month post intervention |
|
|
|
| Secondary | 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. | 14 of the 227 6m responders were missing data at least 1Q and were excluded from dataset. All 4Q are needed for BPI pain intensity to be scored. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 6-month post intervention |
|
|
|
| Secondary | 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. | 20 of the 227 6m responders were missing data at least 4/7Q and were excluded from dataset. At least 50% of questions need to be answered for pain interference to be calculated | Posted | Mean | Standard Deviation | score on a scale | Baseline to 6-month post intervention |
|
|
|
| Secondary | 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. | 24 of the 271 12m responders were missing data at least 1Q and were excluded from dataset. All 4Q are needed for BPI pain intensity to be scored. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 12-month post-intervention |
|
|
|
| Secondary | 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 | 29 of the 271 12m responders were missing data at least 4/7Q and were excluded from dataset. At least 50% of questions need to be answered for pain interference to be calculated | Posted | Mean | Standard Deviation | score on a scale | Baseline to 12-month post intervention |
|
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|
| 0 |
| 189 |
| 0 |
| 189 |
| 0 |
| 189 |
| EG001 | Smoking Cessation Standard (SMK-STD) | A contact-equivalent control that provides standard smoking cessation telephone counseling Smoking Cessation Standard: standard telephone-based smoking cessation intervention | 0 | 182 | 0 | 182 | 0 | 182 |
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| D015438 | Health Behavior |
| D000073869 | Tobacco Smoking |