Opioid TaperingPHOENIXNCT07202026
Prescription Opioid Discontinuation: Honoring Patient Insights and Experience to Support Safe and Caring Transitions -- Decision Aid Pilot
A study testing Patient-centered Decision Aid to support long-term opioid therapy tapering in people with Opioid Tapering, run by Kaiser Permanente at 1 site in United States.
Trial summary
Because of recent policies to decrease opioid use, some people using long-term opioid therapy (LTOT) are encouraged or required to stop (discontinue) taking opioids. That has led experts to be concerned that patients whose LTOT is discontinued could have untreated pain, turn to other substance use and possibly illicit… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Tapering
- What is being tested?
- Patient-centered Decision Aid to support long-term opioid therapy tapering
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2025to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Have been taking opioids for chronic pain for at least 6 months
- Able to speak and read English
- EHR-based exclusion criteria:
- cancer diagnosis in the last 5 years (excluding non-melanoma skin cancers)
- current palliative or hospice care
- cognitive disability
Show all 9Show fewer
- psychiatric hospitalization in the last year
- surgery in the last 6 months
- current residence in an inpatient rehabilitation or skilled nursing facility
Who cannot join
- participated in an interview for Aim 1 of this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Kaiser Permanente Washington Health Research Institute
Seattle, Washington, 98101
About this study
Official title: Patient Perspectives on Prescription Opioid Discontinuation: Understanding and Promoting Safe Transitions
Because of recent policies to decrease opioid use, some people using long-term opioid therapy (LTOT) are encouraged or required to stop (discontinue) taking opioids. That has led experts to be concerned that patients whose LTOT is discontinued could have untreated pain, turn to other substance use and possibly illicit opioids, or have worsened mental health symptoms leading to suicide. To guide safer policies, guidelines, and care, this study will interview patients and doctors about discontinuing LTOT and use the results to develop a patient-centered decision aid (DA) to improve patient-provider communication around discontinuation of LTOT. Once the DA is finalized, it will be pilot tested with a group of 30 patients who are currently on LTOT. The pilot will assess DA implementation feasibility; acceptability; knowledge transfer; and ability to successfully foster positive, patient-centered conversations about opioid discontinuation.
- Conditions
- Opioid Tapering
- Being tested
- Patient-centered Decision Aid to support long-term opioid therapy tapering
- Keywords
- Chronic pain, Decision Aids, Long-term opioid therapy, Opioid tapering
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-centered Decision Aid to support long-term opioid therapy taperingBehavioural
Earlier aims of this study developed a patient-centered Decision Aid (DA) that uses stories of people who benefited from discontinuing and clear explanations of evidence for key choices to decrease stigma; empower patients; increase engagement and productive interaction with providers in decision making; and reduce fear, anger and anxiety about tapering. The DA will be designed to support conversations that providers often find challenging and help providers maintain patient trust and satisfaction. Participants in the pilot test will be asked to: 1) complete a pre-DA survey, 2) review the DA, 3) have a guided conversation with a trained study interventionist with a behavioral health background who is trained on how to use the DA, and 4) complete a post-DA survey.
| Study group | Role | What they receive |
|---|---|---|
| Decision Aid Pilot Test | Experimental | Not described Receives: Behavioral: Patient-centered Decision Aid to support long-term opioid therapy tapering |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of DA
We will use Matlock et al.'s acceptability ranking scale to assess the acceptability of the DA to patients
Measured: 1-2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start29 Oct 2025
- Primary completionMar 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid TaperingStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- University of Arkansas, University of Washington
- Responsible party
- Principal investigator, Clarissa Hsu, Kaiser Permanente
- Investigators
- Clarissa W Hsu, PhD, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07202026
- Sponsor's protocol ID
- R01HS027790
- Other IDs
- R01HS027790
- Acronym
- PHOENIX
- Status last verified
- Oct 2025
- First submitted
- 23 Sep 2025
- Last updated
- 5 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Perspectives on Prescription Opioid Discontinuation: Understanding and Promoting Safe Transitions
- ClinicalTrials.gov ID
- NCT07202026
- Acronym / sponsor ID
- PHOENIX / R01HS027790
- Conditions
- Opioid Tapering
- Keywords
- Chronic pain, Decision Aids, Long-term opioid therapy, Opioid tapering
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- University of Arkansas, University of Washington
- Study start
- 29 Oct 2025 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 1 Oct 2025 (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.
Because of recent policies to decrease opioid use, some people using long-term opioid therapy (LTOT) are encouraged or required to stop (discontinue) taking opioids. That has led experts to be concerned that patients whose LTOT is discontinued could have untreated pain, turn to other substance use and possibly illicit opioids, or have worsened mental health symptoms leading to suicide. To guide safer policies, guidelines, and care, this study will interview patients and doctors about discontinuing LTOT and use the results to develop a patient-centered decision aid (DA) to improve patient-provider communication around discontinuation of LTOT. Once the DA is finalized, it will be pilot tested with a group of 30 patients who are currently on LTOT. The pilot will assess DA implementation feasibility; acceptability; knowledge transfer; and ability to successfully foster positive, patient-centered conversations about opioid discontinuation.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Decision Aid Pilot Test | Experimental | Behavioral: Patient-centered Decision Aid to support long-term opioid therapy tapering |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Have been taking opioids for chronic pain for at least 6 months
- Able to speak and read English
- cancer diagnosis in the last 5 years (excluding non-melanoma skin cancers)
- current palliative or hospice care
- cognitive disability
Key exclusion criteria (1 listed)
- participated in an interview for Aim 1 of this study
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 |
|---|---|---|
| Patient-centered Decision Aid to support long-term opioid therapy taperingEarlier aims of this study developed a patient-centered Decision Aid (DA) that uses stories of people who benefited from discontinuing and clear explanations of evidence for key choices to decrease stigma; empower patients; increase engagement and productive interaction with providers in decision making; and reduce fear, anger and anxiety about tapering. The DA will be designed to support conversations that providers often find challenging and help providers maintain patient trust and satisfaction. Participants in the pilot test will be asked to: 1) complete a pre-DA survey, 2) review the DA, 3) have a guided conversation with a trained study interventionist with a behavioral health background who is trained on how to use the DA, and 4) complete a post-DA survey. | Behavioural | Decision Aid Pilot Test |
Primary outcome
Acceptability of DA
Time frame: 1-2 weeks
We will use Matlock et al.'s acceptability ranking scale to assess the acceptability of the DA to patients
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2025.
- Individual participant dataSharing planned: No
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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.
Clarissa W Hsu, PhD principal investigator
Kaiser Permanente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient-centered Decision Aid to support long-term opioid therapy tapering in people with Opioid Tapering, run by Kaiser Permanente 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 9 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 5 Nov 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Acceptability of DA (time frame: 1-2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Nov 2025.