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Discontinuation vs Continuation of Long-term Opioid Therapy in Suboptimal and Optimal Responders With Chronic Pain

NCT02741076 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2019-11-06

Study results available
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Summary

The purpose of this study is to evaluate the effect on pain intensity (PI) of structured discontinuation of long-term opioid analgesic therapy compared to continuation of opioid therapy in Suboptimal and Optimal Responders to high-dose, long-term opioid analgesic therapy for chronic low back pain (CLBP).

Conditions

  • Opioid-Related Disorders
  • Opiate Addiction
  • Narcotic Abuse
  • Drug Abuse

Interventions

DRUG

Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER)

Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER)

DRUG

Continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER)

Continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER)

Sponsors & Collaborators

  • Member Companies of the Opioid PMR Consortium

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-14
Primary Completion
2018-04-27
Completion
2018-04-27

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02741076 on ClinicalTrials.gov