Health Outcomes from Opioid Therapy for Chronic Pain
Bruce D Naliboff PhD MA
VA Greater Los Angeles Health Care System
Los Angeles, CA
Funding Period: October 2000 - September 2004

BACKGROUND/RATIONALE:
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.

OBJECTIVE(S):
The 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.

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 every three months thereafter. In addition, the following individual difference variables will be examined to determine patient characteristics which 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 every three months thereafter.

FINDINGS/RESULTS:
Analysis of initial data indicates significant relationships between affective measures of anxiety and depression, disability, and opioid medication use. Anxiety may better predict opioid use than history of previous substance abuse. Depression appears to predict disability. Data analysis will be completed to determine whether there are specific levels of anxiety and/or depression that will predict narcotic medication misuse. We have also continued assessment of our testing instruments to assess substance abuse behaviors for pain medications and are working on publishing reliability and validity data of a new scale to evaluated these behaviors. We have continued to update our study database and are applying programs for data QA and initial analysis. We have also checked opiate data to ensure separation of the two treatment groups on opiate dosage.

IMPACT:
Initial data from this study was presented at several national meetings and emphasized the validity and proper use of urine toxicology screening and the important role of affective processes in chronic pain treatment and medication abuse.

PUBLICATIONS:

Journal Articles

1. Naliboff BD, Wu SM, Pham Q. Clinical considerations in the treatment of chronic pain with opiates. Journal of Clinical Psychology. 2006; 62(11): 1397-408.
2. Wu SM, Compton P, Bolus R, Schieffer B, Pham Q, Baria A, Van Vort W, Davis F, Shekelle P, Naliboff BD. The addiction behaviors checklist: validation of a new clinician-based measure of inappropriate opioid use in chronic pain. Journal of Pain and Symptom Management. 2006; 32(4): 342-51.
3. Divono EC, Singh M, Renner SW, Baria AM, Schieffer B, Korobkin S, Naliboff BD. Comparison of opiate test results obtained from the LX20, AxSYM, REMEDi HS and RapidOne Oxy testing systems with prescribed medications. Clinical Chemistry. 2003; 49(S6): A77.

DRA: Aging and Age-Related Changes, Chronic Diseases
DRE: Quality of Care, Treatment
Keywords: Drug abuse, Pain, Patient outcomes
MeSH Terms: none