Smoking CessationNCT03616743
Brief Pain and Smoking Cessation Intervention in Adults With Chronic Pain
A study testing Psychoeducation in people with Smoking Cessation, run by Mayo Clinic.
Trial summary
A brief smoking cessation intervention was developed to address smoking in the context of chronic pain to increase the intention to engage in smoking cessation treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 2 Nov 2015to 31 Oct 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
- age ≥18 years
- chronic pain of greater than 3 months duration
- smoke at least 10 cigarettes daily
Who cannot join
- cancer-related pain
- current participation in a smoking abstinence program
- current self-guided attempt to reduce or abstain from smoking
- use of other forms of tobacco including pipe, cigar or chew
- history of schizophrenia or other chronic psychotic disorder
- history of a dementing illness
About this study
Official title: Effects of a Brief Pain and Smoking Cessation Intervention in Adults With Chronic Pain: A Randomized Controlled Trial
A brief smoking cessation intervention was developed to address smoking in the context of chronic pain to increase the intention to engage in smoking cessation treatment.
Read the detailed description
The primary aim of this randomized controlled trial was to investigate the effects of a brief pain and smoking (BPS) cessation intervention on the willingness to consider quitting smoking in adults with chronic pain seeking treatment in a pain specialty outpatient clinic. The investigators hypothesized that participants randomized to the BPS intervention, relative to a brief non-tailored control smoking (BCS) intervention, would be more likely to self-report willingness to consider quitting smoking. Secondary aims included examining the effects of group allocation on the (1) interest in learning about smoking cessation programs; (2) willingness to consider scheduling a smoking cessation program; (3) scheduling a smoking cessation program; and (4) change scores of the Thoughts About Abstinence Scale (TAAS).
- Conditions
- Smoking Cessation
- Being tested
- Psychoeducation, Brief smoking control arm
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychoeducationBehavioural
Psychoeducation about the links between smoking and chronic pain.
Brief smoking control armBehavioural
Psychoeducation about the general adverse effects of smoking.
| Study group | Role | What they receive |
|---|---|---|
| Brief pain and smoking arm | Experimental | The experimental arm incorporated a novel psychoeducational component that addressed associations between cigarette smoking and chronic pain Receives: Behavioral: Psychoeducation |
| Brief smoking control arm | Active comparator | The brief smoking control arm was comprised of the "5A's" of smoking cessation. Receives: Behavioral: Brief smoking control arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-report willingness to consider quitting smoking.
Single question with a binary self-report answer of Yes/No.
Measured: Immediate post-intervention assessment
Secondary outcomes (1)
Thoughts About Abstinence Scale
The Thoughts About Abstinence Scale is a self-report questionnaire that assesses the desire to quit smoking, anticipated difficulty quitting, and anticipated success quitting smoking.
Measured: Pre-intervention and immediately post-intervention assessments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start2 Nov 2015
- Primary completion31 Oct 2016
- Study completion31 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, W. Michael Hooten, Mayo Clinic
- Investigators
- William M Hooten, MD, Principal investigator, Professor of Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03616743
- Sponsor's protocol ID
- 14-000475
- Status last verified
- Jul 2018
- First submitted
- 18 Jul 2018
- Last updated
- 6 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only a summary of group data will be shared.
Publications
Hooten WM, Townsend CO, Hays JT, Ebnet KL, Gauvin TR, Gehin JM, Laures HJ, Patten CA, Warner DO. A cognitive behavioral smoking abstinence intervention for adults with chronic pain: a randomized controlled pilot trial. Addict Behav. 2014 Mar;39(3):593-9. doi: 10.1016/j.addbeh.2013.11.010. Epub 2013 Nov 21.
PubMed 24333035Hooten WM, LaRowe LR, Zale EL, Ditre JW, Warner DO. Effects of a brief pain and smoking cessation intervention in adults with chronic pain: A randomized controlled trial. Addict Behav. 2019 May;92:173-179. doi: 10.1016/j.addbeh.2018.11.040. Epub 2018 Nov 28.
PubMed 30641335
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Brief Pain and Smoking Cessation Intervention in Adults With Chronic Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03616743
- Acronym / sponsor ID
- 14-000475
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 2 Nov 2015 (actual)
- Primary completion
- 31 Oct 2016 (actual)
- Study completion
- 31 Oct 2016 (actual)
- First posted
- 6 Aug 2018 (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.
A brief smoking cessation intervention was developed to address smoking in the context of chronic pain to increase the intention to engage in smoking cessation treatment.
Detailed description
The primary aim of this randomized controlled trial was to investigate the effects of a brief pain and smoking (BPS) cessation intervention on the willingness to consider quitting smoking in adults with chronic pain seeking treatment in a pain specialty outpatient clinic. The investigators hypothesized that participants randomized to the BPS intervention, relative to a brief non-tailored control smoking (BCS) intervention, would be more likely to self-report willingness to consider quitting smoking. Secondary aims included examining the effects of group allocation on the (1) interest in learning about smoking cessation programs; (2) willingness to consider scheduling a smoking cessation program; (3) scheduling a smoking cessation program; and (4) change scores of the Thoughts About Abstinence Scale (TAAS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Brief pain and smoking arm | Experimental | Behavioral: PsychoeducationThe experimental arm incorporated a novel psychoeducational component that addressed associations between cigarette smoking and chronic pain |
| Brief smoking control arm | Active comparator | Behavioral: Brief smoking control armThe brief smoking control arm was comprised of the "5A's" of smoking cessation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age ≥18 years
- chronic pain of greater than 3 months duration
- smoke at least 10 cigarettes daily
Key exclusion criteria (6 listed)
- cancer-related pain
- current participation in a smoking abstinence program
- current self-guided attempt to reduce or abstain from smoking
- use of other forms of tobacco including pipe, cigar or chew
- history of schizophrenia or other chronic psychotic disorder
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 |
|---|---|---|
| PsychoeducationPsychoeducation about the links between smoking and chronic pain. | Behavioural | Brief pain and smoking arm |
| Brief smoking control armPsychoeducation about the general adverse effects of smoking. | Behavioural | Brief smoking control arm |
Primary outcome
Self-report willingness to consider quitting smoking.
Time frame: Immediate post-intervention assessment
Single question with a binary self-report answer of Yes/No.
1 secondary outcome
Thoughts About Abstinence Scale
Time frame: Pre-intervention and immediately post-intervention assessments
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 6 Aug 2018.
- Background: PubMed 24333035Hooten WM, Townsend CO, Hays JT, Ebnet KL, Gauvin TR, Gehin JM, Laures HJ, Patten CA, Warner DO. A cognitive behavioral smoking abstinence intervention for adults with chronic pain: a randomized controlled pilot trial. Addict Behav. 2014 Mar;39(3):593-9. doi: 10.1016/j.addbeh.2013.11.010. Epub 2013 Nov 21.
- Derived from this study: PubMed 30641335Hooten WM, LaRowe LR, Zale EL, Ditre JW, Warner DO. Effects of a brief pain and smoking cessation intervention in adults with chronic pain: A randomized controlled trial. Addict Behav. 2019 May;92:173-179. doi: 10.1016/j.addbeh.2018.11.040. Epub 2018 Nov 28.
- Individual participant dataSharing planned: No. Only a summary of group data will be shared.
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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.
William M Hooten, MD principal investigator
Professor of Anesthesiology
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducation in people with Smoking Cessation, run by Mayo Clinic.
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 6 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 6 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Self-report willingness to consider quitting smoking. (time frame: Immediate post-intervention assessment). 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 NCT03616743, which also lists 2 linked publications.
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 6 Aug 2018.