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Increasing Cessation Motivation and Treatment Engagement Among Smokers in Pain

Increasing Cessation Motivation and Treatment Engagement Among Smokers in Pain

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03996902
Enrollment
76
Registered
2019-06-25
Start date
2016-05-10
Completion date
2016-07-31
Last updated
2019-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain, Smoking, Smoking Cessation

Keywords

Chronic Pain, Tobacco, Smoking, Smoking cessation, Motivation

Brief summary

The goal of this study is to develop and pilot test a brief intervention to increase motivation to quit and smoking cessation treatment engagement among smokers with chronic pain.

Detailed description

Pain and tobacco smoking are both critical national health problems, and there is mounting evidence that smokers in pain may represent an important and large subgroup who experience unique barriers and greater difficulty quitting. Smoking has been identified as a risk factor in the onset and exacerbation of chronic pain, and smokers experience greater levels of pain intensity and disability, relative to non-smokers. Initial evidence indicates that quitting smoking may improve pain outcomes (e.g., lower pain intensity) and supports the notion that smoking cessation may be an essential behavior change for smokers in pain. However, the vast majority of smokers are not yet ready to engage a serious quit attempt, and evidence-based treatments for smoking cessation remain dramatically underutilized. Therefore, the goal of this study is to develop and pilot test a brief intervention that will address smoking in the context of pain in order to increase motivation to quit smoking and engagement of available smoking cessation treatment. Participants will be randomized to either the adapted brief motivational intervention or an intervention consistent with standard clinical practice

Interventions

Brief motivational smoking intervention tailored to address smoking in the context of pain. Included a novel pain-smoking psycho education component, personalized feedback component, and elicitation of participant's pain-related goals to develop discrepancy between continued smoking and desired pain outcomes.

The Ask-Advise-Refer intervention is commonly used in standard clinical practice.

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
Syracuse University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Current daily cigarette smoking (at least 10/day) * Current moderate-very sever chronic pain with a numerical pain rating of at least 4/10 * At least 18 years of age

Exclusion criteria

* Current active attempt to quit smoking * Enrollment in smoking cessation treatment or use of a smoking cessation medication * Less than 18 years of age

Design outcomes

Primary

MeasureTime frameDescription
Motivation to Quit Smoking30 daysMeasured by the Contemplation Ladder and Motivation Rulers. The contemplation ladder is a measure of motivation to quit smoking on an 11 point Visual Analogue Scale. Motivation rulers for smoking cessation consist of three separate NRSs that asses importance of quitting, readiness to quit smoking in the next month, and confidence that you will quit smoking in the next month.
Motivation to engage cessation treatment30 daysAssessed with a single item that asked would you like to learn about options for treatment to help you quit smoking. If participants answered yes they were then asked whether they were interested and planned to enroll in the following types of treatment in the next 30 days: medication/primary care, Quitline, behavioral health, or none of the above.
Knowledge of pain-smoking interrelations30 daysUsing the Pain and Smoking Questionnaire (PSQ) which is a 25 total item questionnaire to asses knowledge of interrelations between pain and tobacco smoking. 17 items assess knowledge of associations between smoking and multiple health conditions. 8 Separate items assess specific knowledge of pain-smoking interrelations such as pain related impairment, whether smoking can cause chronic pain, reduce effectiveness of prescription pain medications, provide analgesic effects, or help to distract from pain.

Secondary

MeasureTime frameDescription
Smoking behavior30 daysParticipants were asked the following questions at the one month follow up: Do you now smoke cigarettes? Over the last week, how many cigarettes did you smoke per day on average? In the Past month, have you cut down on your smoking? In the past month, did you quit smoking for at least 24 hours? In the past month, did you talk to your doctor about your smoking? In the past month, did you start using a medication to help you quit smoking? (check all that apply: no, Over the Counter NRT (Patch, gum, lozenge) Prescription NRT (Inhaler, spray) Non-NRT Prescription (Chantix/Zyban)) In the Past month, did you see a behavioral health provider about your smoking? In the past month, did you call Quitline?
Use of cessation treatment30 daysParticipants were asked the following questions at the one month follow up: Do you now smoke cigarettes? Over the last week, how many cigarettes did you smoke per day on average? In the Past month, have you cut down on your smoking? In the past month, did you quit smoking for at least 24 hours? In the past month, did you talk to your doctor about your smoking? In the past month, did you start using a medication to help you quit smoking? (check all that apply: no, Over the Counter NRT (Patch, gum, lozenge) Prescription NRT (Inhaler, spray) Non-NRT Prescription (Chantix/Zyban)) In the Past month, did you see a behavioral health provider about your smoking? In the past month, did you call Quitline?

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026