Care Management for the Effective Use of Opioids

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 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

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

The investigators will exclude Veterans with an active substance use disorder (i.e., those
currently in treatment), but to maximize generalizability the investigators will not
exclude those with a past history of substance abuse.