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Treating Chronic Pain in Buprenorphine Patients in Primary Care Settings (TOPPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03698669
Recruitment Status : Suspended (Recruitment suspended due to COVID-19 policies; follow up continues remotely.)
First Posted : October 9, 2018
Last Update Posted : May 5, 2020
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Boston University

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.

Condition or disease Intervention/treatment Phase
Opioid-Related Disorders Behavioral: Treating Opioid Patients' Pain and Sadness (TOPPS) Behavioral: Health Education (HE) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treating Chronic Pain in Buprenorphine Patients in Primary Care Settings
Actual Study Start Date : August 21, 2019
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: Treating Opioid Patients' Pain and Sadness (TOPPS)
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)
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.

Active Comparator: Health Education (HE)
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)
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.




Primary Outcome Measures :
  1. Change in Pain Interference based on the BPI-I [ Time Frame: Baseline and Month 12 ]
    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."

  2. Change in Pain Severity based on the VAS [ Time Frame: Baseline and Month 12 ]
    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.

  3. Change in Depression based on the QIDS [ Time Frame: Baseline and Month 12 ]
    The Quick Inventory of Depression Symptoms (QIDS) will be used to measure depression severity and suicidality. It is a commonly-used clinical interview that yields a depression severity score between 0 and 27 with scores of 5 or lower indicative of no depression, scores from 6 to 10 indicating mild depression, 11 to 15 indicating moderate depression, 16 to 20 reflecting severe depression, and total scores greater than 21 indicating very severe depression.


Secondary Outcome Measures :
  1. Rates of buprenorphine treatment retention [ Time Frame: Month 12. ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 SCID Module's A and B/C (6) 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) SSDI or 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03698669


Locations
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United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Stanley Street Treatment and Resources
Fall River, Massachusetts, United States, 02720
Sponsors and Collaborators
Boston University
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Michael D Stein, MD Boston University
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Responsible Party: Boston University
ClinicalTrials.gov Identifier: NCT03698669    
Other Study ID Numbers: H-38056
1R01DA045695 ( U.S. NIH Grant/Contract )
First Posted: October 9, 2018    Key Record Dates
Last Update Posted: May 5, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Boston University:
Depression
Pain
Cognitive behavioral therapy (CBT)
Buprenorphine
Behavioral health specialist (BHS)
Primary care provider (PCP)
Additional relevant MeSH terms:
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Chronic Pain
Opioid-Related Disorders
Pain
Neurologic Manifestations
Signs and Symptoms
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents