Skip to main content
OpenTrials
Completed

NCT Number: NCT01752998

Treating Chronic Pain in Buprenorphine Patients in Primary Care Settings

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain Behavior Behavioral Symptoms Chemically-Induced Disorders Depression Mental Disorders Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Substance Use Substance-Related Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Butler Hospital

Providence, Rhode Island, 02906, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Treating Opioid Patients' Pain and Sadness (TOPPS)

Behavioral

Health Education

Behavioral

Primary outcomes

  1. Pain

    Time frame: 4 months

    Pain, as measured by self-report

Secondary outcomes

  1. Depression

    Time frame: 4 months

    Depression, as measured by self-report and clinician-administered assessments

  2. Substance Use

    Time frame: 4 months

    Illicit substance use, as measured by self-report and urine toxicology

Sponsors and collaborators

Lead sponsor

Butler Hospital

Other

Registry information

Acronym: BupPain

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Dec 19, 2012
Registry last updated
Sep 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.