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

Primary Purpose

Pain, Depression, Substance Use

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Treating Opioid Patients' Pain and Sadness (TOPPS)
Health Education
Sponsored by
Butler Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring pain, depression, substance use

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Butler Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

TOPPS Intervention

Health Education

Arm Description

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.

Individuals randomized into this arm will receive 7 individual sessions on general health education.

Outcomes

Primary Outcome Measures

Pain
Pain, as measured by self-report

Secondary Outcome Measures

Depression
Depression, as measured by self-report and clinician-administered assessments
Substance Use
Illicit substance use, as measured by self-report and urine toxicology

Full Information

First Posted
December 17, 2012
Last Updated
September 15, 2017
Sponsor
Butler Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01752998
Brief Title
Treating Chronic Pain in Buprenorphine Patients in Primary Care Settings
Acronym
BupPain
Official Title
Treating Chronic Pain in Buprenorphine Patients in Primary Care Settings
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Butler Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Depression, Substance Use
Keywords
pain, depression, substance use

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TOPPS Intervention
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Health Education
Arm Type
Placebo Comparator
Arm Description
Individuals randomized into this arm will receive 7 individual sessions on general health education.
Intervention Type
Behavioral
Intervention Name(s)
Treating Opioid Patients' Pain and Sadness (TOPPS)
Intervention Type
Behavioral
Intervention Name(s)
Health Education
Primary Outcome Measure Information:
Title
Pain
Description
Pain, as measured by self-report
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Depression
Description
Depression, as measured by self-report and clinician-administered assessments
Time Frame
4 months
Title
Substance Use
Description
Illicit substance use, as measured by self-report and urine toxicology
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Stein, MD
Organizational Affiliation
Butler Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Butler Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States

12. IPD Sharing Statement

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Treating Chronic Pain in Buprenorphine Patients in Primary Care Settings

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