Treating Chronic Pain in Buprenorphine Patients in Primary Care Settings

Study Overview
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Brief Summary
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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
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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.

Official Title
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Treating Chronic Pain in Buprenorphine Patients in Primary Care Settings

Conditions
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Opioid-Related Disorders

Intervention / Treatment
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* Behavioral: Treating Opioid Patients' Pain and Sadness (TOPPS)
* Behavioral: Health Education (HE)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 18 and 65 years of age 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 Pain severity of 4 or higher on a numerical rating scale (0-10) indicating worst pain in the last week If using an antidepressant, the dose must be stable for the previous 2 months Has received buprenorphine from the current primary care provider for at least the last month Continuing buprenorphine with no plan to taper dose for the next 12 months 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 Gives informed consent to participate in the study. Exclusion Criteria: Expected surgery in the next 3 months Pain thought to be due to cancer, infection, or inflammatory arthritis Greater than or equal to 10 days of cocaine/crack/methamphetamine use in the past month Current mania or past year psychosis as determined via SCID Module's A and B/C Lifetime diagnosis of schizophrenia or other chronic psychotic condition as determined by the study PI Moving within 12 months which would require a change in Buprenorphine provider SSDI or SSI claim pending Pregnancy or planned pregnancy in the next 6 months. Greater than 8 homeless nights in the past month Suicide ideation or behavior requiring immediate attention Not able to provide informed consent Not able to complete interviews in English Unable to provide names and contact information for at least two verifiable locator persons who will know where to find them in the future. Greater than or equal to 45 days without a phone in the past 3 months/no reliable access to phone

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treating Opioid Patients' Pain and Sadness (TOPPS)<br>TOPPS, consists of three main components: (1) psychoeducation about pain, depression, opioid use, their interactions, and the maintaining role of avoidance; (2) coaching in being an informed, activated patient (based in part on the chronic care model and on approaches to self-management of chronic illness); and (3) behavioral activation to increase engagement in meaningful activities. | Behavioral: Treating Opioid Patients' Pain and Sadness (TOPPS)<br>* TOPPS involves an initial face-to-face meeting followed by regular phone meetings. In preliminary research, patients found this format to be convenient. The initial meeting includes the patient, the BHS and the PCP; the PCP then regularly receives treatment notes from the BHS. Also, the PCP, who has a longitudinal relationship with the patient, is encouraged to further reinforce TOPPS goals. After each TOPPS session, the BHS also mails a copy of the clinical note to the patient. Additionally, each participant is provided with a workbook that reviews the key elements of each treatment session and provides exercises for at-home practice of skills.<br>|
| Active Comparator: Health Education (HE)<br>After an initial, brief, joint, in-person meeting with the BHS and primary care physician (PCP), patients have a session that discusses nutrition. For the next 5 telephone sessions, they choose from a menu of topics, including: a second session on nutrition; germs, colds and the flu; preventing cancer; diabetes; protecting your heart; getting a good night's sleep; complementary and alternative medicine; caffeine, or physical activity. | Behavioral: Health Education (HE)<br>* After an initial, brief, joint, in-person meeting with the BHS and primary care physician (PCP), patients have a session that discusses nutrition. For the next 5 telephone sessions, they choose from a menu of topics, including: a second session on nutrition; germs, colds and the flu; preventing cancer; diabetes; protecting your heart; getting a good night's sleep; complementary and alternative medicine; caffeine, or physical activity. This control condition was accepted by our participants in preliminary studies; it does not directly target functional impairment, and participants do not set tailored goals relating to their own values. The BHS will communicate with the PCP only if a participant shows signs of clinical deterioration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain Interference based on the BPI-I | The Brief Pain Inventory Interference Scale (BPI-I) will be used to capture the domain of pain interference with physical and psychosocial functioning. The pain interference subscale includes 7 questions assessing the degree to which pain interferes with general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life using a 0-to-10 numeric rating score. For interference items, 0 represents does not interfere and 10 indicates interferes completely. | Baseline and Month 3 | 
| Change in Pain Severity based on the VAS | Pain severity will be measured by the Visual Analogue Scale (VAS) presented as a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of no pain at all and worst pain imaginable. Participants will indicate worst and average pain in the last week. | Baseline and Month 3 | 
| Change in Depression based on the PHQ-9 | The Patient Health Questionnaire (PHQ-9) will be used to measure depression severity and suicidality. It is the major depressive disorder module of the full PHQ. Scores range from 0-27, with scores less than or equal to 4 suggesting minimal depression, scores from 5 to 9 indicating mild depression, 10 to 14 indicating moderately depression, 15 to 19 reflecting moderately severe depression, and scores greater than 20 indicating severe depression. | Baseline and Month 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of buprenorphine treatment retention | Using clinical records at the recruitment sites, we will record the date of last buprenorphine treatment visit and calculate the treatment retention rates up to 12 months. | Month 9 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Pain, Cognitive behavioral therapy (CBT), Buprenorphine, Behavioral health specialist (BHS), Primary care provider (PCP)