Treating Chronic Pain in Buprenorphine Patients in Primary Care Settings
CompletedNot applicableNCT01752998
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Individuals will be recruited by posted advertisements in the waiting rooms of the PCP offices and by physician referral. After an initial phone screen, research staff will meet with interested individuals in their PCP offices for informed consent, baseline interview and randomization. Participants will be randomized into a Health Education study arm, and receive 7 individual sessions on general health education, or an Intervention study arm, and receive 7 individual sessions of the Treating Opioid Patients' Pain and Sadness (TOPPS) intervention.
Study details
- Official title
- Treating Chronic Pain in Buprenorphine Patients in Primary Care Settings
- Conditions
- Pain
- Depression
- Substance Use
- Interventions
- Behavioral: Treating Opioid Patients' Pain and Sadness (TOPPS)
- Behavioral: Health Education
- Sponsor
- Butler Hospital
- Start date
- 2012-09
- Primary completion
- 2017-08
- Sex
- All
- Age range
- from 18 Years to 75 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Chronic Pain, defined as pain duration for at least six months with a mean score of 5 or higher on the BPI Pain Interference Scale; * Pain severity of 40 or higher on a Visual Analog Scale (0-100) indicating "worst pain in the last week"; * Previous attempt at initial steps of PCP guideline pain care: must have had at least one trial of recommended medication (i.e. acetaminophen, NSAIDS, skeletal muscle relaxants) judged through interviews with patients and PCPs; * QIDS score of ≥ 10 (depression severity) * If using an antidepressant, the dose must be stable for the previous 2 months; * Age 18 or older * Has received buprenorphine/naloxone (Suboxone)for at least the last 3 months; * Plan to continue buprenorphine/naloxone (Suboxone)for at least 3 months. Exclusion Criteria: * Lifetime DSM-IV diagnosis of bipolar disorder, schizophrenia, or other chronic psychotic condition; * Current DSM-IV diagnosis of substance dependence for sedative/hypnotic drugs, alcohol, stimulants, or cocaine; * Suicidal ideation or behavior requiring immediate attention; * In psychotherapy or in a multidisciplinary pain management program at baseline; * Anticipate having surgery in the next 6 months; * Pain thought to be due to cancer, infection, inflammatory arthritis, or associated with severe or progressive neurological deficits; * SSDI or SSI claim pending; * Pregnancy.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01752998