Chronic Non-cancer PainPOTSNCT01883882
Pilot Trial of Opioid Taper Support
A study testing opioid taper support in people with Chronic Non-cancer Pain, run by University of Washington at 1 site in United States.
Trial summary
The proposed research will develop, demonstrate the feasibility of, and pilot test in a randomized controlled trial a prescription opioid taper support intervention. This intervention aims to prevent opioid misuse and adverse events among patients receiving chronic opioid therapy for chronic non-cancer pain without… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Non-cancer Pain
- What is being tested?
- opioid taper support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Jun 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18-80 years;
- CNCP, defined as pain on more than half the days in the past six months, where indicated diagnostic workup is complete and treatment is focused on pain;
- currently on COT, defined as self-report of prescribed oral opioid medication use on a daily or near-daily (>90% of days) basis for 90 days or more;
- mean daily opioid dose in the past 30 days of 25 mg MED or greater;
- willing to participate in the study arm to which they are randomly assigned (including opioid taper in-person sessions if randomized to that group);
- able to read, speak, and write English.
Who cannot join
- currently receiving treatment for cancer (other than non-melanoma skin cancer);
- medical comorbidity with life expectancy less than a year (based on medical record review by the PI);
- recent use (past month) of parenteral, transdermal, or transmucosal opioids,
- currently residing in nursing home;
- currently using intrathecal pump for pain control;
- any current substance abuse according to the DSM-IV checklist (nicotine and marijuana will be allowed since Washington State allows medical marijuana for pain control);
Show all 10Show fewer
- presence of illicit drug metabolite in baseline urine drug test,
- psychotic symptoms, psychiatric hospitalization or suicide attempts in the past year;
- current suicidal ideation with specific plan or intent;
- significant cognitive impairment (on 6-item screener Scale).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington Center for Pain Relief
Seattle, Washington, 98115
About this study
Official title: Pilot Randomized Trial of Opioid Taper Support
The proposed research will develop, demonstrate the feasibility of, and pilot test in a randomized controlled trial a prescription opioid taper support intervention. This intervention aims to prevent opioid misuse and adverse events among patients receiving chronic opioid therapy for chronic non-cancer pain without evidence of current substance abuse.
The project will yield information essential to planning a future, larger-scale RCT designed to evaluate: 1) the efficacy of the intervention in preventing prescription opioid abuse, misuse, overdose and other adverse events among patients receiving chronic opioid therapy for chronic non-cancer pain, 2) the effects of the intervention on opioid use, pain, pain related activity interference, and mood. Participants in our pilot study will be limited to those without current opioid abuse or other substance abuse, but past substance abuse will be allowed. This will provide a sample of patients at risk for opioid abuse, misuse and overdose, but who may be able to taper their opioids successfully. Hypothesis: Patients receiving chronic opioid therapy for chronic non-cancer pain who are randomized to the opioid taper support intervention, as compared with patients randomized to usual opioid prescribing care, will have lower opioid average daily doses at 22 and 34 weeks.
- Conditions
- Chronic Non-cancer Pain
- Being tested
- opioid taper support
- Keywords
- chronic non-cancer pain, opioid taper, chronic pain self-management, motivational interviewing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
opioid taper supportBehavioural
Weekly visits with physician's assistant (supervised by pain physician/psychiatrist and pain psychologist) who provides pharmacological and psychological support for opioid taper at 10% per week
| Study group | Role | What they receive |
|---|---|---|
| taper support | Experimental | Weekly visits with pharmacological and psychological support for opioid taper at 10% of original dose per week Receives: Behavioral: opioid taper support |
| Usual care | No intervention | Usual care for chronic pain. All care allowed except buprenorphine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean daily opioid dose over past week
mean daily opioid dose over past week as calculated in morphine equivalent dose
Measured: week 22 after randomization
Secondary outcomes (1)
prescription opioid difficulties
Prescription opioid difficulties subscale scores on: psychosocial problems and opioid control concerns
Measured: week 22 after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionMay 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Non-cancer 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
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Mark Sullivan, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01883882
- Sponsor's protocol ID
- 43641-B
- Other IDs
- R34DA033384
- Acronym
- POTS
- Status last verified
- Oct 2016
- First submitted
- 18 Jun 2013
- Last updated
- 24 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Trial of Opioid Taper Support
- ClinicalTrials.gov ID
- NCT01883882
- Acronym / sponsor ID
- POTS / 43641-B
- Conditions
- Chronic Non-cancer Pain
- Keywords
- chronic non-cancer pain, opioid taper, chronic pain self-management, motivational interviewing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jun 2013
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 21 Jun 2013 (estimated)
- 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 proposed research will develop, demonstrate the feasibility of, and pilot test in a randomized controlled trial a prescription opioid taper support intervention. This intervention aims to prevent opioid misuse and adverse events among patients receiving chronic opioid therapy for chronic non-cancer pain without evidence of current substance abuse.
The project will yield information essential to planning a future, larger-scale RCT designed to evaluate: 1) the efficacy of the intervention in preventing prescription opioid abuse, misuse, overdose and other adverse events among patients receiving chronic opioid therapy for chronic non-cancer pain, 2) the effects of the intervention on opioid use, pain, pain related activity interference, and mood. Participants in our pilot study will be limited to those without current opioid abuse or other substance abuse, but past substance abuse will be allowed. This will provide a sample of patients at risk for opioid abuse, misuse and overdose, but who may be able to taper their opioids successfully. Hypothesis: Patients receiving chronic opioid therapy for chronic non-cancer pain who are randomized to the opioid taper support intervention, as compared with patients randomized to usual opioid prescribing care, will have lower opioid average daily doses at 22 and 34 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| taper support | Experimental | Behavioral: opioid taper supportWeekly visits with pharmacological and psychological support for opioid taper at 10% of original dose per week |
| Usual care | No intervention | –Usual care for chronic pain. All care allowed except buprenorphine. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- age 18-80 years;
- CNCP, defined as pain on more than half the days in the past six months, where indicated diagnostic workup is complete and treatment is focused on pain;
- currently on COT, defined as self-report of prescribed oral opioid medication use on a daily or near-daily (>90% of days) basis for 90 days or more;
- mean daily opioid dose in the past 30 days of 25 mg MED or greater;
- willing to participate in the study arm to which they are randomly assigned (including opioid taper in-person sessions if randomized to that group);
Key exclusion criteria (10 listed)
- currently receiving treatment for cancer (other than non-melanoma skin cancer);
- medical comorbidity with life expectancy less than a year (based on medical record review by the PI);
- recent use (past month) of parenteral, transdermal, or transmucosal opioids,
- currently residing in nursing home;
- currently using intrathecal pump 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 |
|---|---|---|
| opioid taper supportWeekly visits with physician's assistant (supervised by pain physician/psychiatrist and pain psychologist) who provides pharmacological and psychological support for opioid taper at 10% per week | Behavioural | taper support |
Primary outcome
mean daily opioid dose over past week
Time frame: week 22 after randomization
mean daily opioid dose over past week as calculated in morphine equivalent dose
1 secondary outcome
prescription opioid difficulties
Time frame: week 22 after randomization
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 24 Oct 2016.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing opioid taper support in people with Chronic Non-cancer 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 6 inclusion and 10 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 24 Oct 2016. 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?
mean daily opioid dose over past week (time frame: week 22 after randomization). 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 24 Oct 2016.