Treating Chronic Pain in Buprenorphine Patients in Primary Care Settings

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Pain, Depression, Substance Use

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


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TOPPS Intervention<br>Individuals randomized into this arm will receive 7 individual sessions of the Treating Opioid Patients' Pain and Sadness (TOPPS) intervention, designed to reduce symptoms of pain and depression. | Behavioral: Treating Opioid Patients' Pain and Sadness (TOPPS)<br> <br> |
| Placebo Comparator: Health Education<br>Individuals randomized into this arm will receive 7 individual sessions on general health education. | Behavioral: Health Education<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Pain, as measured by self-report | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression | Depression, as measured by self-report and clinician-administered assessments | 4 months | 
| Substance Use | Illicit substance use, as measured by self-report and urine toxicology | 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pain, depression, substance use