Clinical trial NCT03698669: Treating Chronic Pain in Buprenorphine Patients in Primary Care Settings
Official title: Treating Chronic Pain in Buprenorphine Patients in Primary Care Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-Related Disorders
Keywords: Depression
Pain
Cognitive behavioral therapy (CBT)
Buprenorphine
Behavioral health specialist (BHS)
Primary care provider (PCP)
Lead sponsor: Boston University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2018-10-09
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Treating Opioid Patients' Pain and Sadness (TOPPS) focuses on the relationship of pain, depression, opioid and other substance misuse, and functioning. It has a structured agenda, uses behavioral activation, involves explicit and ongoing psychoeducation, and includes a behavioral health specialist (BHS) trained extensively in the nature of pain and opioid misuse, including how to assess for red flags of opioid relapse. Devised specifically for primary care patients receiving buprenorphine, TOPPS is collaborative (PCP, BHS, and patient) and focuses on pain and physical symptoms in order to decrease the need to turn to substance misuse to avoid pain, and to foster patient's abilities to achieve their long-term life goals. In this study, TOPPS is compared to a health education contact-control condition among 250 persons with opioid use disorder recruited from two primary care based buprenorphine programs. The investigators will provide both interventions over 3 months, and follow the patients for a total of 12 months in order to observe both short-term and longer-term effects of TOPPS.

Detailed description: Nearly 2.5 million individuals in the United States have opioid use disorder (OUD), with the vast majority (2 million) reporting abuse of prescription opioids. Patients with a history of substance use are particularly vulnerable to experiencing pain. Indeed, a large percentage of patients with OUD who receive the effective opioid agonist treatments (OAT) buprenorphine or methadone (MMT), report that pain preceded any use of addictive substances, and that the primary reason for starting opioid use was to reduce pain. Among methadone patients, 37-61% suffer from chronic pain that is often severe and interferes with daily activities. Similarly, in studies of chronic pain in buprenorphine patients, approximately 48% of patients report chronic pain. OAT recipients report far higher rates of chronic pain than the wider US population.

Chronic pain has been associated with negative substance use outcomes in persons receiving buprenorphine for opioid detoxification and in people receiving MMT. Providers may prioritize the treatment of substance use in OUD patients, leaving the concurrent pain untreated. Lack of treatment encourages patients to use illicit opioids for pain relief. Indeed, for persons using buprenorphine, greater pain severity in a given week was significantly associated with increased likelihood of opioid use in the following week.

Pain contributes to other negative outcomes. Pain is an independent risk factor for suicide including in samples of substance use disorder patients. Further, compared to MMT patients without pain, those with pain have significantly greater health problems and psychological distress. Pain, poor health, and low energy are the most commonly cited reasons that OAT patients are physically inactive. The continued physical and social problems in patients with pain influence the perception of (lack of) treatment benefits by both patients and providers.

Duration of opioid agonist treatment (OAT) is a key predictor of long-term abstinence and outcomes improve across a variety of domains if patients remain in care for at least one year. Although buprenorphine is a growing ambulatory treatment, retention in care remains problematic. Across practice sites and, despite variations in visit frequency, the 12-month retention rate ranges from 50-80% with the majority of treatment drop-out occurring during the first three months of treatment. Though few studies have yet examined the role of pain, pain has been found to negatively impact buprenorphine treatment retention.

Studies estimate that approximately one third to one half of MMT and buprenorphine recipients suffer from depression. Several studies have reported that opioid dependent patients with chronic pain have greater depressive symptoms and a greater probability of occupational disability compared to patients with lower level or no chronic pain. Amongst MMT patients, higher psychiatric distress is associated with lower general functioning. Methadone counselors report difficulty treating patients with chronic pain due in part to these patients' co-occurring psychiatric symptoms. In the only study of antidepressant treatment for depressed persons initiating buprenorphine, the investigators found in a secondary analysis that pain is prevalent, interferes with functioning, and its severity plateaus after one month of buprenorphine. Importantly, as with chronic pain, depressive symptoms have been associated with greater likelihood of relapse to opioid use in OAT patients. The substantial overlap of pain and depression in OAT patients suggest that functioning may improve most when depression and pain are simultaneously treated in an integrated fashion that is theoretically-based.

TOPPS is a type of cognitive behavioral therapy (CBT) that consists of three main components: 1) psychoeducation about pain, depression, opioid misuse, their interaction, and the maintaining role of avoidance; 2) coaching in being an informed, activated patient; and 3) behavioral activation with a focus on acceptance. Modern behavioral activation is idiographic and responsive to each patient's unique environment, needs, and goals. The function of a behavior is analyzed, and if the function is avoidance (e.g., of social contact, personal engagement, or physical activity), the behavior is targeted for change. Patients are taught to consider behavioral options, and to choose an option inconsistent with avoidance. There is an implicit attitude of acceptance of thoughts and feelings, as behavior is not dependent on changing thoughts and feelings. Behavior activation for depression focuses on helping patients to set goals in meaningful life areas, and then to break down long-term goals into smaller weekly goals. This process is incompatible with behavioral avoidance and instead, encourages patients to approach meaningful life goals. Barriers that arise in achieving short-term goals are addressed in treatment.

TOPPS focuses on the relationship of pain, depression, opioid and other substance misuse, and functioning. It has a structured agenda, uses behavioral activation, involves explicit and ongoing psychoeducation, and includes a BHS trained extensively in the nature of pain and opioid misuse and relapse. Devised specifically for primary care patients receiving buprenorphine, TOPPS is collaborative (physician, interventionist, and patient) and focuses on depression, pain and physical symptoms in order to decrease the need to turn to substance misuse to avoid pain, increase overall functioning and to foster patient's abilities to achieve their long-term life goals.

Eligibility criteria: Inclusion Criteria:

1. Between 18 and 65 years of age
2. Have chronic pain, defined as pain duration for at least three months with a mean score of 4 or higher on the BPI Pain Interference Scale
3. Pain severity of 4 or higher on a numerical rating scale (0-10) indicating "worst pain in the last week"
4. If using an antidepressant, the dose must be stable for the previous 2 months
5. Has received buprenorphine from the current primary care provider for at least the last month
6. Continuing buprenorphine with no plan to taper dose for the next 12 months
7. Score of at least 1 on PHQ-2 during prescreen or score of greater than or equal to 8 on PHQ-9 during in person screening
8. Gives informed consent to participate in the study.

Exclusion Criteria:

1. Expected surgery in the next 3 months
2. Pain thought to be due to cancer, infection, or inflammatory arthritis
3. Greater than or equal to 10 days of cocaine/crack/methamphetamine use in the past month
4. Current mania or past year psychosis as determined via Structured Clinical Interview for DSM-5 (SCID) Module's A and B/C
5. Lifetime diagnosis of schizophrenia or other chronic psychotic condition as determined by the study PI
6. Moving within 12 months which would require a change in Buprenorphine provider
7. Social Security Disability Insurance (SSDI) or Supplemental Security Income (SSI) claim pending
8. Pregnancy or planned pregnancy in the next 6 months.
9. Greater than 8 homeless nights in the past month
10. Suicide ideation or behavior requiring immediate attention
11. Not able to provide informed consent
12. Not able to complete interviews in English
13. Unable to provide names and contact information for at least two verifiable locator persons who will know where to find them in the future.
14. Greater than or equal to 45 days without a phone in the past 3 months/no reliable access to phone

Primary outcomes:
measure: Change in Pain Interference based on the BPI-I
timeFrame: Baseline and Month 3
measure: Change in Pain Severity based on the VAS
timeFrame: Baseline and Month 3
measure: Change in Depression based on the PHQ-9
timeFrame: Baseline and Month 3
Secondary outcomes:
measure: Rates of buprenorphine treatment retention
timeFrame: Month 9
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Fall River
country: United States
facility: Stanley Street Treatment and Resources
state: Massachusetts
Study officials:
affiliation: Boston University
name: Michael D Stein, MD
role: PRINCIPAL_INVESTIGATOR
References: