Pilot Trial of Opioid Taper Support

Chronic Non-cancer Pain Clinical Trial

— POTS  

Official title:

Pilot Randomized Trial of Opioid Taper Support

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01883882
• Other study ID #: 43641-B
• Secondary ID: R34DA033384
• Status: Completed
• Phase: N/A
• First received: June 18, 2013
• Last updated: October 21, 2016
• Start date: June 2013
• Est. completion date: June 2016

Study information

• Verified date: October 2016
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Non-cancer Pain

Intervention

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

Locations

Country	Name	City	State
United States	University of Washington Center for Pain Relief	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean daily opioid dose over past week	mean daily opioid dose over past week as calculated in morphine equivalent dose	week 22 after randomization	No
Secondary	prescription opioid difficulties	Prescription opioid difficulties subscale scores on: psychosocial problems and opioid control concerns	week 22 after randomization	No