CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 261 enrolled
Drug / intervention
Pharmacological (MED) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01236521
NCT01236521N/ACompleted

Care Management for the Effective Use of Opioids (CAMEO)

VA Office of Research and Development·interventional·Posted Nov 8, 2010·Updated Jul 27, 2023

In Brief

A clinical study evaluating Pharmacological (MED) and Behavioral treatment (CBT) for Low Back Pain and Pain. Completed, enrolled 261 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLow Back Pain, Pain
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 8, 2010
Enrollment StartDec 1, 2011
Primary CompletionDec 11, 2015
Study CompletionDec 31, 2015
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 15.7 years ago

Interventions

Pharmacological (MED)drug

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 treatment (CBT)behavioral

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