View Clinical Trial (Medical Research Study)
Care Management for the Effective Use of Opioids (CAMEO)
| City: |
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Indianapolis |
| State: |
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Indiana |
| Zip Code: |
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46202 |
| Conditions: |
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Low Back Pain - Pain |
| Purpose: |
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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: 1) to compare the interventions' (PHARM vs.
BEH) effects on pain intensity, function, and other pain relevant outcomes at 6 months
(primary end point) and 12 months (sustained effect); and 2) to compare the
cost-effectiveness of the interventions
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| Study Summary: |
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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.
Our study sample will include 450 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
(PHARM). Patients in the behavioral arm (BEH) 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' (PHARM vs. BEH) effects on pain intensity and function at
6 months (primary end point) and 12 months (sustained effect)
2. To compare the interventions' effects (PHARM vs. BEH) on other relevant outcomes
- Patient global impression of change
- Health-related quality of life
- Opioid dose
3. To compare the cost-effectiveness of the interventions
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| Criteria: |
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Inclusion Criteria:
Veterans will be eligible if they have:
- chronic lower back pain of at least moderate intensity
- pain for 6 months
- on chronic opioid therapy
- and access to a working telephone
Exclusion Criteria:
Exclusion criteria includes:
- severe medical conditions
- active psychosis
- schizophrenia
- active suicidal ideation
- pending back surgery
- moderately severe cognitive impairment
- involvement in ongoing pain trials
- and pregnant or trying to become pregnant
We will exclude veterans with an active substance use disorder (i.e., those currently in
treatment), but to maximize generalizability we will not exclude those with a past history
of substance abuse.
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| NCT ID: |
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NCT01236521 |
| Primary Contact: |
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Principal Investigator
Matthew J. Bair, MD MS
Richard Roudebush VA Medical Center
Christy Sargent, BA CRA
Phone: (317) 988-3838
Email: Christy.Sargent@va.gov
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| Backup Contact: |
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Email: Katie.Allen@va.gov
Katie Allen, BS CRA
Phone: (317) 988-4799
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| Location Contact: |
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Indianapolis, Indiana 46202
United States
Dennis Benge, BA MBA
Phone: 317-988-2604
Email: Dennis.Benge@va.gov
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
| Modifications to this listing: |
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