Last reviewed · How we verify

NCT02971137: PASS

Pain and Smoking Study

Completed NA Results posted Last updated 28 July 2023
What this trial tests

NA trial testing Smoking Cessation plus CBI in Smoking in 371 participants. Completed in 31 January 2022.

Timeline
22 December 2017
Primary endpoint
30 October 2021
31 January 2022

Quick facts

Lead sponsorVA Office of Research and Development
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment371
Start date22 December 2017
Primary completion30 October 2021
Estimated completion31 January 2022
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

VA Office of Research and Development — full company profile →

Who can join

18 and older, any sex, with Smoking or Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants Who Abstained From Smoking Cigarettes at 6months (Prolonged Abstinence) Primary · 6-month

In the past 6 months, have he/she smoked any in each of 2 consecutive weeks?

GroupValue95% CI
Smoking Cessation Plus CBI (SMK-CBI)43
Smoking Cessation Standard (SMK-STD)41
Number of Participants Who Abstained From Smoking Cigarettes at 12 Months (Prolonged Abstinence) Primary · 12-month post intervention

In the past 6 months, have he/she smoked any in each of 2 consecutive weeks?

GroupValue95% CI
Smoking Cessation Plus CBI (SMK-CBI)40
Smoking Cessation Standard (SMK-STD)38
Number of Participants Who Abstained From Smoking Part of a Cigarette at 6months (30-day Point Prevalence) Primary · 6-month post intervention

30-day point prevalence abstinence rates, Have he/she smoked at least part of a cigarette in last 30 days?

GroupValue95% CI
Smoking Cessation Plus CBI (SMK-CBI)23
Smoking Cessation Standard (SMK-STD)11
Number of Participants Who Abstained From Smoking Part of a Cigarette at 12 Months (30-day Point Prevalence) Primary · 12 month post intervention

30-day point prevalence abstinence rates, have he/she smoked at least part of a cigarette in last 30 days?

GroupValue95% CI
Smoking Cessation Plus CBI (SMK-CBI)25
Smoking Cessation Standard (SMK-STD)18
Change in Brief Pain Inventory (BPI) Pain Intensity, Difference From Baseline to Follow-up at 6 Months Secondary · Baseline to 6-month post intervention

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.

GroupValue95% CI
Smoking Cessation Plus CBI (SMK-CBI)-0.7± 1.7
Smoking Cessation Standard (SMK-STD)-0.5± 1.8
Change in Pain Interference, Difference Between Baseline and Follow-up at 6 Months Secondary · Baseline to 6-month post intervention

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.

GroupValue95% CI
Smoking Cessation Plus CBI (SMK-CBI)-0.72± 2.4
Smoking Cessation Standard (SMK-STD)-0.36± 2.2
Change in Brief Pain Inventory (BPI) Pain Intensity, Difference in Pain Intensity Between Baseline and 12 Months Secondary · Baseline to 12-month post-intervention

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.

GroupValue95% CI
Smoking Cessation Plus CBI (SMK-CBI)-.044± 1.6
Smoking Cessation Standard (SMK-STD)-0.35± 1.7
Change in Pain Interference, Difference Between Baseline and Interference Secondary · Baseline to 12-month post intervention

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

GroupValue95% CI
Smoking Cessation Plus CBI (SMK-CBI)-.56± 2.3
Smoking Cessation Standard (SMK-STD)-.46± 2.1

Sponsor's own description

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

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Pain and smoking study (PASS): A comparative effectiveness trial of smoking cessation counseling for veterans with chronic pain.
    Bastian LA, Driscoll M, DeRycke E, Edmond S, et al · · 2021 · cited 6× · PMID 34485755 · DOI 10.1016/j.conctc.2021.100839
  2. Characteristics of Urban Inpatient Smokers With and Without Chronic Pain: Foundations for Targeted Cessation Programs.
    Cody GR, Wang B, Link AR, Sherman SE. · · 2019 · cited 4× · PMID 30706753 · DOI 10.1080/10826084.2018.1563186
  3. Smoking Cessation Among Patients with Chronic Pain in a Comparative Effectiveness Trial.
    Bastian LA, Driscoll MA, Goulet JL, DeRycke EC, et al · · 2025 · PMID 41413292 · DOI 10.1007/s11606-025-10083-x
  4. Factors associated with participation in a walking intervention for veterans who smoke and have chronic pain.
    Muller RD, Driscoll MA, DeRycke EC, Edmond SN, et al · · 2024 · PMID 39143444 · DOI 10.1007/s10865-024-00511-4

Verify or expand the search:

Other recruiting trials for Smoking

Currently open trials in the same condition.

Other VA Office of Research and Development trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02971137.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing