Clinical trial NCT03950791: Single Session Class to Reduce Opioid Use in Chronic Pain
Official title: Single Session Pain Catastrophizing Class: Efficacy & Mechanisms for Reducing Opioid Use Among Chronic Pain Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2019-05-15
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prescription opioids are one of the most commonly used treatments for chronic pain, despite limited evidence of their efficacy and high morbidity and mortality risks. The study aims to determine the efficacy of a targeted single-session psychology class in reducing opioid use among patients with chronic pain. The information gained from this study has the potential to identify patients who achieve a meaningful reduction in opioid use and inform opioid reduction strategies.

Detailed description: The opioid epidemic is a serious national crisis that affects public health as well as social and economic welfare, with increasing and alarming mortality rates in the United States. Consequently, there is an urgent need for effective and efficient interventions to address opioid use to prevent the risk of opioid misuse and better address it once it is established. One of the greatest predictors for increased opioid use among patients with chronic pain is pain catastrophizing (PC), defined as persistent negative cognitive and emotional responses to actual or anticipated pain. Untreated PC can lead to increased opioid use and facilitate the risk for misuse and overuse of medications, particularly when surgery and pharmacologics are the focal medical care plan. Despite critical need, there are no targeted interventions that efficiently address the key psychological factors that can amplify both pain, need for opioids, and increased risk for misuse. This project aims to address this urgent need for efficient and effective solutions. A 2-hour targeted, single-session pain catastrophizing class (PC-class) has been developed, rooted in cognitive-behavior therapy (CBT) approaches, aimed at reducing opioid use by reducing pain catastrophizing in chronic pain. This targeted, brief treatment obviates many of the existing barriers and burdens to usual comprehensive pain-CBT, such as the time required to attend 8 sessions, insurance coverage, travel costs, lack of skilled clinicians, patient attrition, and copayments. The investigators will implement a randomized controlled trial comparing the PC-class to a health education control class. Aim 1, To determine the efficacy of the PC class in reducing opioid use among patients with mixed-etiology pain conditions. Aim 2, To collect daily data that will allow the conduct of analyses on the daily experience of catastrophizing and how it relates to opioid use, as well as its dynamic response to treatment. The investigators will use this daily data to characterize the mechanistic influence of catastrophizing on opioid use both on the daily-level and prospectively. Patient outcomes will be longitudinally tracked at 1, 3, 6, and 12 months after the intervention session. This project aims to identify patients who achieve a meaningful reduction in opioid use, which will enable better characterization of treatment responders and refining opioid reduction strategies.

Eligibility criteria: Inclusion Criteria:

* 18-80 years of age
* Diagnosis of chronic non-cancer pain (\> 3 months in duration)
* Currently using prescription opioids ≥ 10mg morphine equivalent daily dose (MEDD) for ≥ 3 months;
* Ability and willingness to complete study procedures.

Exclusion Criteria:

* Open litigation regarding a medical condition
* Inability to provide informed consent and complete study procedures
* Previous experience with cognitive behavioral therapy (CBT)
* Active suicidality.

Primary outcomes:
measure: Opioid Use
timeFrame: baseline and 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Maisa Ziadni, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ziadni MS, Chen AL, Winslow T, Mackey SC, Darnall BD. Efficacy and mechanisms of a single-session behavioral medicine class among patients with chronic pain taking prescription opioids: study protocol for a randomized controlled trial. Trials. 2020 Jun 12;21(1):521. doi: 10.1186/s13063-020-04415-x.