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Care Management for the Effective Use of Opioids

NCT01236521 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 261

Last updated 2023-07-27

Study results available
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Summary

The CAre Management for the Effective use of Opioids (CAMEO) trial is a 2-arm randomized clinical trial to compare the effectiveness of pharmacological vs. behavioral approaches for chronic lower back pain. The study aims are to compare the interventions' (PHARM vs. BEH) effects on pain intensity, pain interference, function, and other pain relevant outcomes over 12 months.

Conditions

  • Low Back Pain
  • Pain

Interventions

DRUG

Pharmacological (MED)

During the baseline assessment, the nurse care managers will determine current and past treatments for chronic lower back pain and establish whether or not patients have had an adequate trial (i.e., were analgesics sufficiently dosed). If not, the nurse care manager in conjunction with study doctors will recommend an adjustment of the patients' opioid or initiate treatment with a co-analgesic with appropriate dosing and scheduling. The Patients in the MED arm will be asked to sign an opioid treatment agreement at enrollment.

BEHAVIORAL

Behavioral treatment (CBT)

There will be 8 sessions of pain self-management and coping skills.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Matthew J. Bair, MD MS · Richard L. Roudebush VA Medical Center, Indianapolis, IN

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-12-01
Primary Completion
2015-12-11
Completion
2015-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT01236521 on ClinicalTrials.gov