Clinical trial NCT01883882: Pilot Trial of Opioid Taper Support
Official title: Pilot Randomized Trial of Opioid Taper Support
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Non-cancer Pain
Keywords: chronic non-cancer pain
opioid taper
chronic pain self-management
motivational interviewing
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2013-06-21
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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).

Primary outcomes:
measure: mean daily opioid dose over past week
timeFrame: week 22 after randomization
Secondary outcomes:
measure: prescription opioid difficulties
timeFrame: week 22 after randomization
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington Center for Pain Relief
state: Washington
Study officials:
References: