Treating Chronic Pain in Buprenorphine Patients in Primary Care Settings (NCT03698669) | Clinical Trial Compass
CompletedNot Applicable
Treating Chronic Pain in Buprenorphine Patients in Primary Care Settings
United States163 participantsStarted 2019-08-21
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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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 Brief Pain Inventory (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 ≥4 on Personal Health Questionnaire-9 instrument (at least "mild" depression severity)
✓. Gives informed consent to participate in the study.
Exclusion criteria
✕. Expected surgery in the next 3 months
What they're measuring
1
Pain Interference Based on the Brief Pain Inventory
Timeframe: 3 Months
2
Pain Severity Based on the Brief Pain Inventory
Timeframe: 3 Months
3
Depression Based on the Patient Health Questionnaire-9