Chronic PainNCT03996902
Increasing Cessation Motivation and Treatment Engagement Among Smokers in Pain
A study testing Tailored intervention and Ask-Advise-Refer in people with Chronic Pain and Smoking, run by Syracuse University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain, Smoking, Smoking Cessation
- What is being tested?
- Tailored intervention and Ask-Advise-Refer
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2016to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Current active attempt to quit smoking
- Enrollment in smoking cessation treatment or use of a smoking cessation medication
- Less than 18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Chronic Pain, Smoking, Smoking Cessation
- Being tested
- Tailored intervention, Ask-Advise-Refer
- Keywords
- Chronic Pain, Tobacco, Smoking, Smoking cessation, Motivation
- Medical subject headings
- Chronic Pain, Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored interventionBehavioural
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.
Ask-Advise-ReferBehavioural
The Ask-Advise-Refer intervention is commonly used in standard clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Tailored intervention | Experimental | Brief Motivational Smoking Intervention Receives: Behavioral: Tailored intervention |
| Control | Experimental | Intervention consistent with standard clinical practice (Control) Receives: Behavioral: Ask-Advise-Refer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motivation to Quit Smoking
Measured 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.
Measured: 30 days
Motivation to engage cessation treatment
Assessed 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.
Measured: 30 days
Knowledge of pain-smoking interrelations
Using 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.
Measured: 30 days
Secondary outcomes (2)
Smoking behavior
Participants 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?"
Measured: 30 days
Use of cessation treatment
Participants 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?"
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start10 May 2016
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Syracuse University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Emily Zale, PhD, Principal investigator, Syracuse University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03996902
- Sponsor's protocol ID
- SyracuseU
- Other IDs
- F31DA039628
- Status last verified
- Jun 2019
- First submitted
- 17 Jun 2019
- Last updated
- 25 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data with other researchers.
Publications
Zale EL, Maisto SA, De Vita MJ, Hooten WM, Ditre JW. Increasing cessation motivation and treatment engagement among smokers in pain: A pilot randomized controlled trial. Exp Clin Psychopharmacol. 2021 Dec;29(6):593-604. doi: 10.1037/pha0000424. Epub 2020 Aug 6.
PubMed 32757595
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Cessation Motivation and Treatment Engagement Among Smokers in Pain
- ClinicalTrials.gov ID
- NCT03996902
- Acronym / sponsor ID
- SyracuseU
- Conditions
- Chronic Pain, Smoking, Smoking Cessation
- Keywords
- Chronic Pain, Tobacco, Smoking, Smoking cessation, Motivation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Syracuse UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 10 May 2016 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 25 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tailored intervention | Experimental | Behavioral: Tailored interventionBrief Motivational Smoking Intervention |
| Control | Experimental | Behavioral: Ask-Advise-ReferIntervention consistent with standard clinical practice (Control) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Current active attempt to quit smoking
- Enrollment in smoking cessation treatment or use of a smoking cessation medication
- Less than 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tailored interventionBrief 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. | Behavioural | Tailored intervention |
| Ask-Advise-ReferThe Ask-Advise-Refer intervention is commonly used in standard clinical practice. | Behavioural | Control |
Primary outcome
Motivation to Quit Smoking
Time frame: 30 days
Measured 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 treatment
Time frame: 30 days
Assessed 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 interrelations
Time frame: 30 days
Using 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.
2 secondary outcomes
Smoking behavior
Time frame: 30 days
Use of cessation treatment
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2019.
- Derived from this study: PubMed 32757595Zale EL, Maisto SA, De Vita MJ, Hooten WM, Ditre JW. Increasing cessation motivation and treatment engagement among smokers in pain: A pilot randomized controlled trial. Exp Clin Psychopharmacol. 2021 Dec;29(6):593-604. doi: 10.1037/pha0000424. Epub 2020 Aug 6.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data with other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily Zale, PhD principal investigator
Syracuse University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored intervention and Ask-Advise-Refer in people with Chronic Pain and Smoking, run by Syracuse University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motivation to Quit Smoking (time frame: 30 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03996902, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2019.