Pilot Trial of Opioid Taper Support (POTS)

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.

Study Overview

• Status: Completed
• Conditions: Chronic Non-cancer Pain
• Intervention / Treatment: Behavioral: opioid taper support

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98115
      • University of Washington Center for Pain Relief

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean daily opioid dose over past week	mean daily opioid dose over past week as calculated in morphine equivalent dose	week 22 after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
prescription opioid difficulties	Prescription opioid difficulties subscale scores on: psychosocial problems and opioid control concerns	week 22 after randomization

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: National Institute on Drug Abuse (NIDA)

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: June 18, 2013
• First Submitted That Met QC Criteria: June 20, 2013
• First Posted (Estimate): June 21, 2013

Study Record Updates

• Last Update Posted (Estimate): October 24, 2016
• Last Update Submitted That Met QC Criteria: October 21, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: motivational interviewing; chronic non-cancer pain; opioid taper; chronic pain self-management
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics; Analgesics, Opioid
• Other Study ID Numbers: 43641-B; R34DA033384 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No