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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Michael Stein, MD, Butler Hospital
ClinicalTrials.gov Identifier:
NCT01752998
First received: December 17, 2012
Last updated: December 10, 2015
Last verified: November 2015
  Purpose
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
Pain
Depression
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


Enrollment: 28
Study Start Date: September 2012
Estimated Study Completion Date: September 2016
Primary Completion Date: November 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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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 ClinicalTrials.gov identifier: NCT01752998

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

Responsible Party: Michael Stein, MD, Principal Investigator, Butler Hospital
ClinicalTrials.gov Identifier: NCT01752998     History of Changes
Other Study ID Numbers: DA032800  1205-002 
Study First Received: December 17, 2012
Last Updated: December 10, 2015
Health Authority: United States: National Institutes of Health

Keywords provided by Butler Hospital:
pain
depression
substance use

Additional relevant MeSH terms:
Depression
Chronic Pain
Behavioral Symptoms
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Analgesics, Opioid
Buprenorphine
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists

ClinicalTrials.gov processed this record on July 28, 2016