Trial Outcomes & Findings for Pain and Smoking Study (NCT NCT02971137)

NCT ID: NCT02971137

Last Updated: 2023-07-28

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 371 participants
• Primary outcome timeframe: 6-month
• Results posted on: 2023-07-28

Participant Flow

Participant milestones

Measure	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	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
Overall Study STARTED	189	182
Overall Study COMPLETED	145	126
Overall Study NOT COMPLETED	44	56

Reasons for withdrawal

Measure	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	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
Overall Study Lost to Follow-up	44	56

Baseline Characteristics

Pain and Smoking Study

Baseline characteristics by cohort

Measure	Smoking Cessation Plus CBI (SMK-CBI) n=189 Participants 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	Smoking Cessation Standard (SMK-STD) n=182 Participants A contact-equivalent control that provides standard smoking cessation telephone counseling Smoking Cessation Standard: standard telephone-based smoking cessation intervention	Total n=371 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	133 Participants n=5 Participants	130 Participants n=7 Participants	263 Participants n=5 Participants
Age, Categorical >=65 years	56 Participants n=5 Participants	52 Participants n=7 Participants	108 Participants n=5 Participants
Age, Continuous	60 Years n=5 Participants	60 Years n=7 Participants	60 Years n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants	26 Participants n=7 Participants	44 Participants n=5 Participants
Sex: Female, Male Male	171 Participants n=5 Participants	156 Participants n=7 Participants	327 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants	16 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	179 Participants n=5 Participants	165 Participants n=7 Participants	344 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	50 Participants n=5 Participants	47 Participants n=7 Participants	97 Participants n=5 Participants
Race (NIH/OMB) White	123 Participants n=5 Participants	112 Participants n=7 Participants	235 Participants n=5 Participants
Race (NIH/OMB) More than one race	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants	14 Participants n=7 Participants	21 Participants n=5 Participants
Region of Enrollment United States	189 Participants n=5 Participants	182 Participants n=7 Participants	371 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6-month

Population: 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

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

Outcome measures

Measure	Smoking Cessation Plus CBI (SMK-CBI) n=189 Participants 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	Smoking Cessation Standard (SMK-STD) n=182 Participants A contact-equivalent control that provides standard smoking cessation telephone counseling Smoking Cessation Standard: standard telephone-based smoking cessation intervention
Number of Participants Who Abstained From Smoking Cigarettes at 6months (Prolonged Abstinence)	43 Participants	41 Participants

PRIMARY outcome

Timeframe: 12-month post intervention

Population: 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

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

Outcome measures

Measure	Smoking Cessation Plus CBI (SMK-CBI) n=189 Participants 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	Smoking Cessation Standard (SMK-STD) n=182 Participants A contact-equivalent control that provides standard smoking cessation telephone counseling Smoking Cessation Standard: standard telephone-based smoking cessation intervention
Number of Participants Who Abstained From Smoking Cigarettes at 12 Months (Prolonged Abstinence)	40 Participants	38 Participants

PRIMARY outcome

Timeframe: 6-month post intervention

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

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

Outcome measures

Measure	Smoking Cessation Plus CBI (SMK-CBI) n=189 Participants 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	Smoking Cessation Standard (SMK-STD) n=182 Participants A contact-equivalent control that provides standard smoking cessation telephone counseling Smoking Cessation Standard: standard telephone-based smoking cessation intervention
Number of Participants Who Abstained From Smoking Part of a Cigarette at 6months (30-day Point Prevalence)	23 Participants	11 Participants

PRIMARY outcome

Timeframe: 12 month post intervention

Population: 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

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

Outcome measures

Measure	Smoking Cessation Plus CBI (SMK-CBI) n=189 Participants 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	Smoking Cessation Standard (SMK-STD) n=182 Participants A contact-equivalent control that provides standard smoking cessation telephone counseling Smoking Cessation Standard: standard telephone-based smoking cessation intervention
Number of Participants Who Abstained From Smoking Part of a Cigarette at 12 Months (30-day Point Prevalence)	25 Participants	18 Participants

SECONDARY outcome

Timeframe: Baseline to 6-month post intervention

Population: 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.

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.

Outcome measures

Measure	Smoking Cessation Plus CBI (SMK-CBI) n=110 Participants 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	Smoking Cessation Standard (SMK-STD) n=103 Participants A contact-equivalent control that provides standard smoking cessation telephone counseling Smoking Cessation Standard: standard telephone-based smoking cessation intervention
Change in Brief Pain Inventory (BPI) Pain Intensity, Difference From Baseline to Follow-up at 6 Months	-0.7 score on a scale Standard Deviation 1.7	-0.5 score on a scale Standard Deviation 1.8

SECONDARY outcome

Timeframe: Baseline to 6-month post intervention

Population: 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

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.

Outcome measures

Measure	Smoking Cessation Plus CBI (SMK-CBI) n=106 Participants 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	Smoking Cessation Standard (SMK-STD) n=101 Participants A contact-equivalent control that provides standard smoking cessation telephone counseling Smoking Cessation Standard: standard telephone-based smoking cessation intervention
Change in Pain Interference, Difference Between Baseline and Follow-up at 6 Months	-0.72 score on a scale Standard Deviation 2.4	-0.36 score on a scale Standard Deviation 2.2

SECONDARY outcome

Timeframe: Baseline to 12-month post-intervention

Population: 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.

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.

Outcome measures

Measure	Smoking Cessation Plus CBI (SMK-CBI) n=135 Participants 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	Smoking Cessation Standard (SMK-STD) n=112 Participants A contact-equivalent control that provides standard smoking cessation telephone counseling Smoking Cessation Standard: standard telephone-based smoking cessation intervention
Change in Brief Pain Inventory (BPI) Pain Intensity, Difference in Pain Intensity Between Baseline and 12 Months	-.044 score on a scale Standard Deviation 1.6	-0.35 score on a scale Standard Deviation 1.7

SECONDARY outcome

Timeframe: Baseline to 12-month post intervention

Population: 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

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

Outcome measures

Measure	Smoking Cessation Plus CBI (SMK-CBI) n=128 Participants 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	Smoking Cessation Standard (SMK-STD) n=114 Participants A contact-equivalent control that provides standard smoking cessation telephone counseling Smoking Cessation Standard: standard telephone-based smoking cessation intervention
Change in Pain Interference, Difference Between Baseline and Interference	-.56 score on a scale Standard Deviation 2.3	-.46 score on a scale Standard Deviation 2.1

Adverse Events

Smoking Cessation Plus CBI (SMK-CBI)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Smoking Cessation Standard (SMK-STD)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Lori A. Bastian

VA Connecticut Healthcare System

Phone: 203-932-5711

Email: lori.bastian@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place