Health Outcomes From Opioid Therapy for Chronic Pain
Condition: Chronic Pain; Behavior, Addictive
MeSH terms: Chronic Pain; Behavior, Addictive
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Physician Treatment Guidelines
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Health Services Research
Keywords: chronic non-malignant pain; opiates; prescriptions; addiction