Pilot Trial of Opioid Taper Support
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 4/21/2016 |
| Start Date: | June 2013 |
| End Date: | June 2016 |
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.
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.
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).
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