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Care Management for the Effective Use of Opioids (CAMEO)
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.
The general purpose of the CAre Management for the Effective use of Opioids (CAMEO) study is to develop, test, and implement novel treatments and care delivery models that address barriers to effective pain management and that can be practicably applied in VA primary care settings for chronic low back pain (CLBP). The CAMEO trial is a 2-arm randomized clinical trial to compare the effectiveness of pharmacological vs. behavioral approaches for CLBP. The investigators' study sample will target 272 Veterans with moderate to severe CLBP despite long-term opioid therapy. Patients from five primary care clinics at the Roudebush VA Medical Center and two community based outpatient clinics will be recruited to participate in CAMEO and randomized to one of two treatment arms. The pharmacological arm will involve guideline-concordant opioid management coupled with algorithm-based co-analgesic treatment (MED). Patients in the behavioral arm (CBT) will receive pain self-management/coping skills training. The trial will last 12-months and all participants will undergo comprehensive outcome assessments at baseline, 3, 6, 9, and 12 months. Study Aims: Among Veterans with chronic low back pain refractory to long-term opioid therapy 1. To compare the interventions' (MED vs. CBT) effects on pain intensity and function over 12 months 2. To compare the interventions' effects (MED vs. CBT) on other relevant outcomes * Health-related quality of life * Pain Catastrophizing * Depression * Anxiety * Disability * Opioid misuse and opioid dose
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Indianapolis, Indiana, United States
Start Date
December 1, 2011
Primary Completion Date
December 11, 2015
Completion Date
December 31, 2015
Last Updated
July 27, 2023
261
ACTUAL participants
Pharmacological (MED)
DRUG
Behavioral treatment (CBT)
BEHAVIORAL
Lead Sponsor
VA Office of Research and Development
NCT06346132
NCT07482709
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07351968