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Pilot Trial of Opioid Taper Support (POTS)

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ClinicalTrials.gov Identifier: NCT01883882
Recruitment Status : Completed
First Posted : June 21, 2013
Last Update Posted : October 24, 2016
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Mark Sullivan, University of Washington

Brief 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 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.


Condition or disease Intervention/treatment Phase
Chronic Non-cancer Pain Behavioral: opioid taper support Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Randomized Trial of Opioid Taper Support
Study Start Date : June 2013
Actual Primary Completion Date : May 2016
Actual Study Completion Date : June 2016

Arm Intervention/treatment
Experimental: taper support
Weekly visits with pharmacological and psychological support for opioid taper at 10% of original dose per week
Behavioral: opioid taper support
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

No Intervention: Usual care
Usual care for chronic pain. All care allowed except buprenorphine.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. prescription opioid difficulties [ Time Frame: week 22 after randomization ]
    Prescription opioid difficulties subscale scores on: psychosocial problems and opioid control concerns



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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);
  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01883882


Locations
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United States, Washington
University of Washington Center for Pain Relief
Seattle, Washington, United States, 98115
Sponsors and Collaborators
University of Washington
National Institute on Drug Abuse (NIDA)
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Responsible Party: Mark Sullivan, Prinicipal Study Investigator, University of Washington
ClinicalTrials.gov Identifier: NCT01883882    
Other Study ID Numbers: 43641-B
R34DA033384 ( U.S. NIH Grant/Contract )
First Posted: June 21, 2013    Key Record Dates
Last Update Posted: October 24, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Mark Sullivan, University of Washington:
chronic non-cancer pain
opioid taper
chronic pain self-management
motivational interviewing
Additional relevant MeSH terms:
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Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents