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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Butler Hospital
Information provided by (Responsible Party):
Michael Stein, MD, Butler Hospital Identifier:
First received: December 17, 2012
Last updated: July 16, 2014
Last verified: July 2014

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.

Condition Intervention
Substance Use
Behavioral: Treating Opioid Patients' Pain and Sadness (TOPPS)
Behavioral: Health Education

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treating Chronic Pain in Buprenorphine Patients in Primary Care Settings

Resource links provided by NLM:

Further study details as provided by Butler Hospital:

Primary Outcome Measures:
  • Pain [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Pain, as measured by self-report

Secondary Outcome Measures:
  • Depression [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Depression, as measured by self-report and clinician-administered assessments

  • Substance Use [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    Illicit substance use, as measured by self-report and urine toxicology

Estimated Enrollment: 55
Study Start Date: September 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01752998

Contact: Michael Stein, MD 401-455-6646

United States, Rhode Island
Butler Hospital Recruiting
Providence, Rhode Island, United States, 02906
Principal Investigator: Michael Stein, MD         
Sponsors and Collaborators
Butler Hospital
Principal Investigator: Michael Stein, MD Butler Hospital
  More Information

No publications provided

Responsible Party: Michael Stein, MD, Principal Investigator, Butler Hospital Identifier: NCT01752998     History of Changes
Other Study ID Numbers: DA032800, 1205-002
Study First Received: December 17, 2012
Last Updated: July 16, 2014
Health Authority: United States: National Institutes of Health

Keywords provided by Butler Hospital:
substance use

Additional relevant MeSH terms:
Chronic Pain
Depressive Disorder
Behavioral Symptoms
Mental Disorders
Mood Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Narcotic Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on November 20, 2014