Predictive variables of prescription opioid misuse in patients with chronic noncancer pain. Development of a risk detection scale: A registered report protocol

BACKGROUND: Opioid therapy is utilized for a broad range of chronic pain conditions. Several studies have highlighted the adverse effects of opioid medication due to the misuse of these drugs. The gradual increase in the use of opioids has become a global phenomenon and is generating social concern. Several treatment guidelines have strongly recommended assessing the risks and benefits of pharmacological treatment with opioids. These guidelines also recommend the psychological assessment of patients with chronic noncancer pain in order to make informed decisions on the advisability of intervention with opioids. Some authors have emphasized the relevance of assessing the risk of opioid misuse in patients with noncancer chronic pain before initiating treatment. METHODS AND ANALYSIS: Two studies will be conducted, each with a different primary objective. The primary objective of the first study (Study 1) will be to conduct a comprehensive investigation to identify the factors most closely associated with subsequent opioid misuse; and based on the results of Study 1, the primary objective of the second study (Study 2) will be to develop a brief, reliable, valid, and useful instrument that would enable health care providers to make decisions on opioid prescription and on the required level of monitoring and follow-up. These decisions would have positive consequences for patient wellbeing. Study 1 will include a logistic regression analysis to test the hypothetical model. Study 2 will have a longitudinal design and include three assessment sessions in order to develop a measure to assess the risk of prescribed opioid misuse and to analyse its reliability and validity. Participants will be individuals with chronic noncancer pain attending three Pain Units. These individuals will either be undergoing pharmacological treatment that includes opioid analgesics (Study 1, N = 400) or are going to commence such treatment (Study 2, N = 250).