Treating Chronic Pain in Buprenorphine Patients in Primary Care Settings

Not Applicable

Completed

• Conditions: Depression; Substance Use; Pain
• Interventions: Behavioral: Health Education; Behavioral: Treating Opioid Patients' Pain and Sadness (TOPPS)

• Registration Number: NCT01752998
• Lead Sponsor: Butler Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-12-17
• Study First Submitted QC: 2012-12-18
• Study First Posted: 2012-12-19
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-15
• Last Update Posted: 2017-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Health Education	Health Education	Individuals randomized into this arm will receive 7 individual sessions on general health education.
TOPPS Intervention	Treating Opioid Patients' Pain and Sadness (TOPPS)	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.

Primary Outcome Measures

Name	Time	Method
Pain	4 months	Pain, as measured by self-report

Secondary Outcome Measures

Name	Time	Method
Depression	4 months	Depression, as measured by self-report and clinician-administered assessments
Substance Use	4 months	Illicit substance use, as measured by self-report and urine toxicology

Trial Locations

Locations (1)

Butler Hospital; 🇺🇸 Providence, Rhode Island, United States