Trial Information

Health Outcomes From Opioid Therapy for Chronic Pain

BACKGROUND AND CLINICAL RELEVANCE: Although the use of opioid medications has gained
increasing acceptance as a treatment option for chronic pain, there is little empirical
research concerning long-term outcomes with this patient population. Several important
questions concerning the use of opioids have yet to be examined in controlled studies. These
include: determination of the most effective dosing regime, specification of the risk
factors for medication abuse, and identification of patients most likely to achieve
long-term benefits. Despite the lack of empirical data, the clinical literature to date
yields two general approaches to the use of opioid treatment with chronic, nonmalignant
pain. The first approach dictates that due to risk of addiction, tolerance, and
insensitivity to large doses, opioid medications should be carefully controlled, with
minimal and stable dosing as the eventual goal of treatment. The second approach, fostered
by the beneficial use of opioids in the treatment of cancer pain, maintains that risk of
addiction and abuse has been exaggerated. Proponents of this approach suggest that
under-medication is a significant cause of treatment failure and non-compliance in chronic
pain patients, and that prescription guidelines should emphasize patients' reports of
adequate relief, regardless of dosage.

OBJECTIVES: The proposed study will test two core hypotheses:

1) What is the best overall approach to long-term (12 month) opioid therapy for chronic
pain, and 2) Which of the potentially important predictor variables mentioned in the
clinical opioid literature are related to outcome in an outpatient Veteran population.

RESEARCH PLAN AND METHODS: The two approaches to opioid use will be operationalized using
medication prescription guidelines as two separate groups (Tolerable Pain Dosage vs.
Adequate Relief Dosage) to be tested in a randomized trial. For the Tolerable Pain group,
opioid medications will be prescribed at initially low doses with the expectation that low
dosing will be adequate to reduce pain to a tolerable level. Dose increases are done slowly
and only based on reports of some relief with low dose, with the goal of low and stable
dosing to prevent dependence and tolerance. For the Adequate Relief group, opioid dosage is
initially rapidly increased until the patient indicates adequate or substantial relief, at
which point dosage is stabilized. For this group, tolerance and dependence are viewed as
signs of inadequate dosing and handled typically with dose increases. Both groups will share
some common guidelines such as monthly monitoring, random screens for other drug use, and
prescriptions limited to a single clinic. Outcome will be measured with respect to primary
outcome variables of pain relief, quality of life, and addictive behaviors, with secondary
outcome variables of medication use, mood, illness beliefs, treatment satisfaction, and
health care utilization. These variables will be assessed at study entry, and at 4 month, 8
month and 12 month follow-up visits. In addition, the following individual difference
variables will be examined to determine patient characteristics that may impact on treatment
outcome: psychosocial factors (e.g., history of substance abuse, economic status,
environmental support), type and chronicity of pain problem, mood, medication use, quality
of life, and illness impact. These variables will also be assessed at study entry and at 4
month, 8 month and 12 month follow-up visits.

PROGRESS REPORT AND CURRENT FINDINGS: Subject enrollment and follow-up has been completed, a
total of 135 subjects were enrolled. Data analysis is ongoing. Primary hypotheses are being
investigated in the current analyses and results are pending.