Chronic PainSTRIPENCT03743402
Strategies to Improve Pain and Enjoy Life
A study testing Pain self-management training, video education, motivational interviewing and voluntary self-paced opioid taper in people with Chronic Pain, run by University of Washington at 1 site in United States.
Trial summary
In the Strategies to Improve Pain and Enjoy Life (STRIPE) study, the effectiveness of a multicomponent intervention will be tested, compared with usual care, on opioid dose and pain outcomes among patients on high dose (≥ 40 mg morphine equivalent dose) long-term opioid therapy in a randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Pain self-management training, video education, motivational interviewing and voluntary self-paced opioid taper
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2019to 27 Jan 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-80 years
- receiving care at a Kaiser Washington primary care clinic;
- Chronic Non-Cancer Pain, defined as patient-reported pain on more than half the days in the past 6 months;
- currently on higher-dose long-term opioid therapy, defined as >90 days' supply in the past 180 days with a mean daily dose of 40 mg MED or greater in the past 90 days, as first identified via Kaiser's pharmacy dispensing data and subsequently validated by patient self-report during screening for the trial
- consent to participate in the study arm to which they are randomly assigned
- able to read, speak, and write English adequate for outcome measures
- enrollment in Kaiser for at least 6 months prior and no plans to disenroll over the next year.
Who cannot join
- receiving treatment for cancer
- enrollment in palliative or hospice care
- use in past year of parenteral, transdermal, or transmucosal opioids
- residing in nursing home or assisted living
- using any implanted device for pain control
- psychotic symptoms, psychiatric hospitalization or suicide attempts in the past year
Show all 9Show fewer
- current suicidal ideation with plan or intent
- dementia diagnosis in Electronic Health Record
- Patients on buprenorphine for any reason, or methadone or naltrexone for treatment of Opioid Use Disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Kaiser Permanente Washington
Seattle, Washington, 98112
About this study
Official title: Randomized Trial of Telephonic Pain Self-management to Promote Opioid Tapering
In the Strategies to Improve Pain and Enjoy Life (STRIPE) study, the effectiveness of a multicomponent intervention will be tested, compared with usual care, on opioid dose and pain outcomes among patients on high dose (≥ 40 mg morphine equivalent dose) long-term opioid therapy in a randomized controlled trial. This intervention will have 4 components: a) telephone-delivered evidence-based pain self-management training, b) web-based video of successfully tapered patients with motivational interviewing debriefing, c) a voluntary, self-paced opioid taper, and d) opioid and non-opioid prescribing guidance for the patient's primary care provider.
Read the detailed description
In a National Institute on Drug Abuse-funded R34 pilot study of pain self-management training for prescription opioid taper support, it was demonstrated that 22 weeks of opioid taper support promotes opioid dose reduction more effectively than usual care (43% vs 19% dose reduction from baseline) with no increase in pain intensity and significantly reduced activity interference. This intervention will now be adapted and tested in a large integrated primary care system. To address patients' fears of opioid taper that limited recruitment into this pilot study, subjects will be randomized to pain self-management training and then offered the option of self-paced opioid taper. Specifically, the effectiveness of this intervention will be tested, compared with usual care, on opioid dose and pain outcomes among patients on moderate-high dose (≥ 40mg morphine equivalent dose) long-term opioid therapy (LtOT) in a randomized controlled trial. This intervention will have 4 components: a) telephone-delivered evidence-based pain self-management training, b) web-based video of successfully tapered patients with motivational interviewing debriefing, c) a voluntary, self-paced opioid taper, and d) opioid and non-opioid prescribing guidance for the patient's primary care provider. Specific Aim 1: To adapt a previously developed prescription opioid taper support intervention into a telephone-delivered pain self-management training that provides the option for supported opioid taper. This will be delivered in multiple primary care clinics by a nurse interventionist trained and supervised by a pain psychologist and will include guidance in opioid and non-opioid medication prescribing. Specific Aim 2: To test in a randomized trial the effects of this intervention on: a) opioid outcomes: daily opioid dose (primary outcome), percent dose reduction from baseline, problem opioid use (questionnaire and electronic health record text indicators), and patient-reported opioid difficulties; and b) pain-related outcomes: PEG (self-report of Pain intensity, Enjoyment of life interference, General activity interference; primary outcome), pain self-efficacy, and anxiety and depression symptoms. Hypotheses pertaining to opioid use: Patients receiving LtOT for chronic non-cancer pain (CNCP) randomized to the STRIPE intervention, as compared with those randomized to usual care, will have lower opioid doses, greater percent reduction of opioid dose, lower proportions with problem opioid use, lower opioid craving, and lower levels of patient-reported opioid-related difficulties at 6 and 12 months after randomization. Hypotheses pertaining to pain outcomes: Patients receiving LtOT for CNCP randomized to the STRIPE intervention, as compared with those randomized to usual care, will have lower PEG scores, higher levels of pain self-efficacy, higher global impression of change, and lower levels of anxiety and depressive symptoms at 6 and 12 months after randomization. The proposed trial will determine whether pain self-management training can promote prescription opioid taper in moderate-higher-dose long-term opioid therapy patients without increasing pain level or activity and enjoyment interference. If this trial is successful, then prescribers and patients may be able to pursue supported opioid taper without fear of escalating pain.
- Conditions
- Chronic Pain
- Being tested
- Pain self-management training, video education, motivational interviewing, voluntary self-paced opioid taper, prescribing guidance for primary care provider, usual care
- Keywords
- long-term opioid therapy, chronic pain self-management, primary care prescribing guidance
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain self-management trainingBehavioural
Also called phone cognitive-behavioral pain self-management training
This intervention will have 4 components:
- telephone-delivered evidence-based pain self-management training,
- web-based video of successfully tapered patients with motivational interviewing debriefing,
- a voluntary, self-paced opioid taper
- opioid and non-opioid prescribing guidance for the patient's primary care provider.
video education, motivational interviewingBehavioural
Also called exposure to successfully tapered patients with debriefing
web-based video of successfully tapered patients with motivational interviewing debriefing
voluntary self-paced opioid taperBehavioural
Also called opioid daily dose reduction
Voluntary self-paced opioid taper where patient chooses whether, when and how much to taper opioids. Taper schedule and strategy will be proposed to patients, but they will negotiate details with their primary care provider.
prescribing guidance for primary care providerBehavioural
Also called medication initiation and adjustment suggestions to optimize control of pain and psychiatric comorbidity
Based upon review of medications and diagnoses in the electronic medical record, the principal investigator will offer guidance on opioid taper rate and strategy. He will also offer suggestions to adjust or initiate other psychotropic medications to treat pain or psychiatric comorbid illness that may be unmasked through opioid taper. All prescriptions will be written by the primary care provider.
usual careOther
Also called standard opioid therapy for chronic pain
Usual care will consist of any and all regular care that may be offered by primary care for chronic pain and related illnesses
| Study group | Role | What they receive |
|---|---|---|
| Pain self-management | Experimental | This intervention will have 4 components:
1. telephone-delivered evidence-based pain self-management training,
2. web-based video of successfully tapered patients with motivational interviewing debriefing,
3. a voluntary, self-paced opioid taper
4. opioid and non-opioid prescribing guidance for the patient's primary care provider. Receives: Behavioral: Pain self-management training; Behavioral: video education, motivational interviewing; Behavioral: voluntary self-paced opioid taper; Behavioral: prescribing guidance for primary care provider |
| usual care | Active comparator | Patients randomized to usual care will continue to receive care as usual from their Kaiser primary care provider. Receives: Other: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Opioid Morphine Milligram Equivalents (MME)
Average over the prior 30 days of the prescribed daily morphine milligram equivalents (MME).
Measured: 12 months after randomization
Pain, Enjoyment of Life, and General Activity (PEG) Score
A 3-item, self-report measure reflecting average pain intensity, pain interference with general activity, and pain interference with enjoyment of life in the past week. It is scored on a scale of 0 to 10; higher scores indicate worse pain intensity and interference with life and enjoyment of activities.
Measured: 12 months after randomization
Secondary outcomes (18)
Daily Opioid Morphine Milligram Equivalents (MME)
Average over the prior 30 days of the prescribed daily morphine milligram equivalents (MME).
Measured: 6 months after randomization
Pain, Enjoyment of Life, and General Activity (PEG) Score
A 3-item, self-report measure reflecting average pain intensity, pain interference with general activity, and pain interference with enjoyment of life in the past week. It is scored on a scale of 0 to 10; higher scores indicate worse pain intensity and interference with life and enjoyment of activities.
Measured: 6 months after randomization
Pain Self-Efficacy Questionnaire (PSEQ) Score
Score from a 10-item questionnaire about pain self-efficacy that range between 0 and 60; higher scores indicate higher confidence in ability to do activities despite pain.
Measured: 6 months after randomization
Pain Self-Efficacy Questionnaire (PSEQ) Score
Score from a 10-item questionnaire about pain self-efficacy that range between 0 and 60; higher scores indicate higher confidence in ability to do activities despite pain.
Measured: 12 months after randomization
Patient Health Questionnaire-8 (PHQ-8) Score
An 8-item questionnaire used to assess depression with scores between 0 and 24; higher scores indicate greater depression severity.
Measured: 6 months after randomization
Patient Health Questionnaire-8 (PHQ-8) Score
An 8-item questionnaire used to assess depression with scores between 0 and 24; higher scores indicate greater depression severity.
Measured: 12 months after randomization
Generalized Anxiety Disorders-7 (GAD-7) Score
A 7-item questionnaire used to assess anxiety with scores between 0 and 21; higher scores indicate greater anxiety severity.
Measured: 6 months after randomization
Generalized Anxiety Disorders-7 (GAD-7) Score
A 7-item questionnaire used to assess anxiety with scores between 0 and 21; higher scores indicate greater anxiety severity.
Measured: 12 months after randomization
Patient Global Impression of Change (PGIC) Score
Single 7-point scale assessing global improvement with treatment, range 0 (bad) - 7 (good)
Measured: 6 months after randomization
Patient Global Impression of Change (PGIC) Score
Single 7-point scale assessing global improvement with treatment, range 0 (bad) - 7 (good)
Measured: 12 months after randomization
Prescription Opioid Misuse Index (POMI) Score
A 6-item questionnaire used to assess problem opioid use with scores between 0 and 6; higher scores indicate a greater likelihood of having opioid use disorder.
Measured: 6 months after randomization
Prescription Opioid Misuse Index (POMI) Score
A 6-item questionnaire used to assess problem opioid use with scores between 0 and 6; higher scores indicate a greater likelihood of having opioid use disorder.
Measured: 12 months after randomization
Prescription Opioid Difficulties Scale (PODS) Score
A 15-item questionnaire used to assess patient-perceived difficulties and concerns attributed to the use of opioid medication with scores between 0 and 60; higher scores indicate greater difficulties and concerns.
Measured: 6 months after randomization
Prescription Opioid Difficulties Scale (PODS) Score
A 15-item questionnaire used to assess patient-perceived difficulties and concerns attributed to the use of opioid medication with scores between 0 and 60; higher scores indicate greater difficulties and concerns.
Measured: 12 months after randomization
Opioid Craving Score
A single-item questionnaire used to assess opioid craving in the past week with scores between 0 and 10; higher scores indicate greater craving.
Measured: 6 months after randomization
Opioid Craving Score
A single-item questionnaire used to assess opioid craving in the past week with scores between 0 and 10; higher scores indicate greater craving.
Measured: 12 months after randomization
At Least 30% Reduction in Daily Opioid Dose
Indication of at least 30% reduction from baseline in the prior 30-day average prescribed morphine milligram equivalents (MME).
Measured: 6 months after randomization
At Least 30% Reduction in Daily Opioid Dose
Indication of at least 30% reduction from baseline in the prior 30-day average prescribed morphine milligram equivalents (MME).
Measured: 12 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start4 Apr 2019
- Primary completion27 Jan 2022
- Study completion27 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Patients are individually randomized to pain self-management training for opioid taper or usual care. Those randomized to pain self-management training will be offered assistance with opioid taper during approximately the fourth session of pain self-management training.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Kaiser Permanente, National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Mark Sullivan, University of Washington
- Investigators
- Mark D Sullivan, MD, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03743402
- Sponsor's protocol ID
- SITE00000193
- Other IDs
- R01DA044970-01
- Acronym
- STRIPE
- Status last verified
- Apr 2023
- First submitted
- 9 Oct 2018
- Last updated
- 7 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Availability of data and materials: The datasets generated and analyzed during the current study are not publicly available to protect participant privacy. Deidentified analysis datasets may be made available upon email request to the corresponding author. Any data shared may require an application with description of the planned research purpose and an execution of a data use agreement with approval from the KPWA IRB overseeing this trial. Further, if the researcher would also like the R analysis code used for this manuscript, they can request this at the time of requesting the deidentified analysis dataset.
Publications
Sullivan MD, Turner JA, DiLodovico C, D'Appollonio A, Stephens K, Chan YF. Prescription Opioid Taper Support for Outpatients With Chronic Pain: A Randomized Controlled Trial. J Pain. 2017 Mar;18(3):308-318. doi: 10.1016/j.jpain.2016.11.003. Epub 2016 Nov 28.
PubMed 27908840Wartko PD, Krakauer C, Turner JA, Cook AJ, Boudreau DM, Sullivan MD. STRategies to Improve Pain and Enjoy life (STRIPE): results of a pragmatic randomized trial of pain coping skills training and opioid medication taper guidance for patients on long-term opioid therapy. Pain. 2023 Dec 1;164(12):2852-2864. doi: 10.1097/j.pain.0000000000002982. Epub 2023 Aug 25.
PubMed 37624901Wartko PD, Boudreau DM, Turner JA, Cook AJ, Wellman RD, Fujii MM, Garcia RC, Moser KA, Sullivan MD. STRategies to Improve Pain and Enjoy life (STRIPE): Protocol for a pragmatic randomized trial of pain coping skills training and opioid medication taper guidance for patients on long-term opioid therapy. Contemp Clin Trials. 2021 Nov;110:106499. doi: 10.1016/j.cct.2021.106499. Epub 2021 Jul 2.
PubMed 34217889
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Telephonic Pain Self-management to Promote Opioid Tapering
- ClinicalTrials.gov ID
- NCT03743402
- Acronym / sponsor ID
- STRIPE / SITE00000193
- Conditions
- Chronic Pain
- Keywords
- long-term opioid therapy, chronic pain self-management, primary care prescribing guidance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Kaiser Permanente, National Institute on Drug Abuse (NIDA)
- Study start
- 4 Apr 2019 (actual)
- Primary completion
- 27 Jan 2022 (actual)
- Study completion
- 27 Jan 2022 (actual)
- First posted
- 16 Nov 2018 (actual)
- Results
- Posted 7 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the Strategies to Improve Pain and Enjoy Life (STRIPE) study, the effectiveness of a multicomponent intervention will be tested, compared with usual care, on opioid dose and pain outcomes among patients on high dose (≥ 40 mg morphine equivalent dose) long-term opioid therapy in a randomized controlled trial. This intervention will have 4 components: a) telephone-delivered evidence-based pain self-management training, b) web-based video of successfully tapered patients with motivational interviewing debriefing, c) a voluntary, self-paced opioid taper, and d) opioid and non-opioid prescribing guidance for the patient's primary care provider.
Detailed description
In a National Institute on Drug Abuse-funded R34 pilot study of pain self-management training for prescription opioid taper support, it was demonstrated that 22 weeks of opioid taper support promotes opioid dose reduction more effectively than usual care (43% vs 19% dose reduction from baseline) with no increase in pain intensity and significantly reduced activity interference. This intervention will now be adapted and tested in a large integrated primary care system. To address patients' fears of opioid taper that limited recruitment into this pilot study, subjects will be randomized to pain self-management training and then offered the option of self-paced opioid taper. Specifically, the effectiveness of this intervention will be tested, compared with usual care, on opioid dose and pain outcomes among patients on moderate-high dose (≥ 40mg morphine equivalent dose) long-term opioid therapy (LtOT) in a randomized controlled trial. This intervention will have 4 components: a) telephone-delivered evidence-based pain self-management training, b) web-based video of successfully tapered patients with motivational interviewing debriefing, c) a voluntary, self-paced opioid taper, and d) opioid and non-opioid prescribing guidance for the patient's primary care provider. Specific Aim 1: To adapt a previously developed prescription opioid taper support intervention into a telephone-delivered pain self-management training that provides the option for supported opioid taper. This will be delivered in multiple primary care clinics by a nurse interventionist trained and supervised by a pain psychologist and will include guidance in opioid and non-opioid medication prescribing. Specific Aim 2: To test in a randomized trial the effects of this intervention on: a) opioid outcomes: daily opioid dose (primary outcome), percent dose reduction from baseline, problem opioid use (questionnaire and electronic health record text indicators), and patient-reported opioid difficulties; and b) pain-related outcomes: PEG (self-report of Pain intensity, Enjoyment of life interference, General activity interference; primary outcome), pain self-efficacy, and anxiety and depression symptoms. Hypotheses pertaining to opioid use: Patients receiving LtOT for chronic non-cancer pain (CNCP) randomized to the STRIPE intervention, as compared with those randomized to usual care, will have lower opioid doses, greater percent reduction of opioid dose, lower proportions with problem opioid use, lower opioid craving, and lower levels of patient-reported opioid-related difficulties at 6 and 12 months after randomization. Hypotheses pertaining to pain outcomes: Patients receiving LtOT for CNCP randomized to the STRIPE intervention, as compared with those randomized to usual care, will have lower PEG scores, higher levels of pain self-efficacy, higher global impression of change, and lower levels of anxiety and depressive symptoms at 6 and 12 months after randomization. The proposed trial will determine whether pain self-management training can promote prescription opioid taper in moderate-higher-dose long-term opioid therapy patients without increasing pain level or activity and enjoyment interference. If this trial is successful, then prescribers and patients may be able to pursue supported opioid taper without fear of escalating pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients are individually randomized to pain self-management training for opioid taper or usual care. Those randomized to pain self-management training will be offered assistance with opioid taper during approximately the fourth session of pain self-management training.
| Arm | Type | Receives |
|---|---|---|
| Pain self-management | Experimental | Behavioral: Pain self-management training, Behavioral: video education, motivational interviewing, Behavioral: voluntary self-paced opioid taper, Behavioral: prescribing guidance for primary care providerThis intervention will have 4 components: 1. telephone-delivered evidence-based pain self-management training, 2. web-based video of successfully tapered patients with motivational interviewing debriefing, 3. a voluntary, self-paced opioid taper 4. opioid and non-opioid prescribing guidance for the patient's primary care provider. |
| usual care | Active comparator | Other: usual carePatients randomized to usual care will continue to receive care as usual from their Kaiser primary care provider. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- age 18-80 years
- receiving care at a Kaiser Washington primary care clinic;
- Chronic Non-Cancer Pain, defined as patient-reported pain on more than half the days in the past 6 months;
- currently on higher-dose long-term opioid therapy, defined as >90 days' supply in the past 180 days with a mean daily dose of 40 mg MED or greater in the past 90 days, as first identified via Kaiser's pharmacy dispensing data and subsequently validated by patient self-report during screening for the trial
- consent to participate in the study arm to which they are randomly assigned
Key exclusion criteria (9 listed)
- receiving treatment for cancer
- enrollment in palliative or hospice care
- use in past year of parenteral, transdermal, or transmucosal opioids
- residing in nursing home or assisted living
- using any implanted device for pain control
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 |
|---|---|---|
| Pain self-management trainingAlso: phone cognitive-behavioral pain self-management trainingThis intervention will have 4 components: 1. telephone-delivered evidence-based pain self-management training, 2. web-based video of successfully tapered patients with motivational interviewing debriefing, 3. a voluntary, self-paced opioid taper 4. opioid and non-opioid prescribing guidance for the patient's primary care provider. | Behavioural | Pain self-management |
| video education, motivational interviewingAlso: exposure to successfully tapered patients with debriefingweb-based video of successfully tapered patients with motivational interviewing debriefing | Behavioural | Pain self-management |
| voluntary self-paced opioid taperAlso: opioid daily dose reductionVoluntary self-paced opioid taper where patient chooses whether, when and how much to taper opioids. Taper schedule and strategy will be proposed to patients, but they will negotiate details with their primary care provider. | Behavioural | Pain self-management |
| prescribing guidance for primary care providerAlso: medication initiation and adjustment suggestions to optimize control of pain and psychiatric comorbidityBased upon review of medications and diagnoses in the electronic medical record, the principal investigator will offer guidance on opioid taper rate and strategy. He will also offer suggestions to adjust or initiate other psychotropic medications to treat pain or psychiatric comorbid illness that may be unmasked through opioid taper. All prescriptions will be written by the primary care provider. | Behavioural | Pain self-management |
| usual careAlso: standard opioid therapy for chronic painUsual care will consist of any and all regular care that may be offered by primary care for chronic pain and related illnesses | Other | usual care |
Primary outcome
Daily Opioid Morphine Milligram Equivalents (MME)
Time frame: 12 months after randomization
Average over the prior 30 days of the prescribed daily morphine milligram equivalents (MME).
Pain, Enjoyment of Life, and General Activity (PEG) Score
Time frame: 12 months after randomization
A 3-item, self-report measure reflecting average pain intensity, pain interference with general activity, and pain interference with enjoyment of life in the past week. It is scored on a scale of 0 to 10; higher scores indicate worse pain intensity and interference with life and enjoyment of activities.
18 secondary outcomes
Daily Opioid Morphine Milligram Equivalents (MME)
Time frame: 6 months after randomization
Pain, Enjoyment of Life, and General Activity (PEG) Score
Time frame: 6 months after randomization
Pain Self-Efficacy Questionnaire (PSEQ) Score
Time frame: 6 months after randomization
Pain Self-Efficacy Questionnaire (PSEQ) Score
Time frame: 12 months after randomization
Patient Health Questionnaire-8 (PHQ-8) Score
Time frame: 6 months after randomization
Patient Health Questionnaire-8 (PHQ-8) Score
Time frame: 12 months after randomization
Generalized Anxiety Disorders-7 (GAD-7) Score
Time frame: 6 months after randomization
Generalized Anxiety Disorders-7 (GAD-7) Score
Time frame: 12 months after randomization
Patient Global Impression of Change (PGIC) Score
Time frame: 6 months after randomization
Patient Global Impression of Change (PGIC) Score
Time frame: 12 months after randomization
Prescription Opioid Misuse Index (POMI) Score
Time frame: 6 months after randomization
Prescription Opioid Misuse Index (POMI) Score
Time frame: 12 months after randomization
Prescription Opioid Difficulties Scale (PODS) Score
Time frame: 6 months after randomization
Prescription Opioid Difficulties Scale (PODS) Score
Time frame: 12 months after randomization
Opioid Craving Score
Time frame: 6 months after randomization
Opioid Craving Score
Time frame: 12 months after randomization
At Least 30% Reduction in Daily Opioid Dose
Time frame: 6 months after randomization
At Least 30% Reduction in Daily Opioid Dose
Time frame: 12 months after randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27908840Sullivan MD, Turner JA, DiLodovico C, D'Appollonio A, Stephens K, Chan YF. Prescription Opioid Taper Support for Outpatients With Chronic Pain: A Randomized Controlled Trial. J Pain. 2017 Mar;18(3):308-318. doi: 10.1016/j.jpain.2016.11.003. Epub 2016 Nov 28.
- Derived from this study: PubMed 37624901Wartko PD, Krakauer C, Turner JA, Cook AJ, Boudreau DM, Sullivan MD. STRategies to Improve Pain and Enjoy life (STRIPE): results of a pragmatic randomized trial of pain coping skills training and opioid medication taper guidance for patients on long-term opioid therapy. Pain. 2023 Dec 1;164(12):2852-2864. doi: 10.1097/j.pain.0000000000002982. Epub 2023 Aug 25.
- Derived from this study: PubMed 34217889Wartko PD, Boudreau DM, Turner JA, Cook AJ, Wellman RD, Fujii MM, Garcia RC, Moser KA, Sullivan MD. STRategies to Improve Pain and Enjoy life (STRIPE): Protocol for a pragmatic randomized trial of pain coping skills training and opioid medication taper guidance for patients on long-term opioid therapy. Contemp Clin Trials. 2021 Nov;110:106499. doi: 10.1016/j.cct.2021.106499. Epub 2021 Jul 2.
- Individual participant dataSharing planned: Yes. Availability of data and materials: The datasets generated and analyzed during the current study are not publicly available to protect participant privacy. Deidentified analysis datasets may be made available upon email request to the corresponding author. Any data shared may require an application with description of the planned research purpose and an execution of a data use agreement with approval from the KPWA IRB overseeing this trial. Further, if the researcher would also like the R analysis code used for this manuscript, they can request this at the time of requesting the deidentified analysis dataset.
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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.
Mark D Sullivan, MD, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain self-management training, video education, motivational interviewing and voluntary self-paced opioid taper in people with Chronic Pain, run by University of Washington 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 7 inclusion and 9 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 7 Apr 2023. 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?
Yes. Results are posted in the registry (first posted 7 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Daily Opioid Morphine Milligram Equivalents (MME) (time frame: 12 months after randomization). The study lists 2 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 NCT03743402, which also lists 3 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 7 Apr 2023.