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Completed

NCT Number: NCT01883882

Pilot 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.

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Key information

Conditions

Chronic Non-cancer Pain

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington Center for Pain Relief

Seattle, Washington, 98115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

opioid taper support

Behavioral

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

Primary outcomes

  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 outcomes

  1. prescription opioid difficulties

    Time frame: week 22 after randomization

    Prescription opioid difficulties subscale scores on: psychosocial problems and opioid control concerns

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Pilot Randomized Trial of Opioid Taper Support

Acronym: POTS

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jun 21, 2013
Registry last updated
Oct 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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