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

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 Overview

• Status: Completed
• Conditions: Depression; Pain; Substance Use
• Intervention / Treatment: Behavioral: Health Education; Behavioral: Treating Opioid Patients' Pain and Sadness (TOPPS)

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • Butler Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: TOPPS Intervention; 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)
Placebo Comparator: Health Education; Individuals randomized into this arm will receive 7 individual sessions on general health education.	Behavioral: Health Education

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

Collaborators and Investigators

• Sponsor: Butler Hospital
• Investigators: Principal Investigator: Michael Stein, MD, Butler Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2012
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): August 1, 2017

Study Registration Dates

• First Submitted: December 17, 2012
• First Submitted That Met QC Criteria: December 18, 2012
• First Posted (Estimate): December 19, 2012

Study Record Updates

• Last Update Posted (Actual): September 18, 2017
• Last Update Submitted That Met QC Criteria: September 15, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: pain; depression; substance use
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Chemically-Induced Disorders; Pain; Neurologic Manifestations; Substance-Related Disorders; Depression; Chronic Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics; Analgesics, Opioid
• Other Study ID Numbers: DA032800; 1205-002 (Other Identifier: Butler Hospital)