Pilot Trial of Opioid Taper Support (POTS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01883882|
Recruitment Status : Completed
First Posted : June 21, 2013
Last Update Posted : October 24, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Non-cancer Pain||Behavioral: opioid taper support||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||35 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Randomized Trial of Opioid Taper Support|
|Study Start Date :||June 2013|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||June 2016|
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.
- 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
- prescription opioid difficulties [ Time Frame: week 22 after randomization ]Prescription opioid difficulties subscale scores on: psychosocial problems and opioid control concerns
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01883882
|United States, Washington|
|University of Washington Center for Pain Relief|
|Seattle, Washington, United States, 98115|