Overview

This trial is active, not recruiting.

Conditions pain, depression, substance use
Treatments treating opioid patients' pain and sadness (topps), health education
Sponsor Butler Hospital
Start date September 2012
End date November 2015
Trial size 28 participants
Trial identifier NCT01752998, 1205-002, DA032800

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
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.
treating opioid patients' pain and sadness (topps)
(Placebo Comparator)
Individuals randomized into this arm will receive 7 individual sessions on general health education.
health education

Primary Outcomes

Measure
Pain
time frame: 4 months

Secondary Outcomes

Measure
Depression
time frame: 4 months
Substance Use
time frame: 4 months

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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.

Additional Information

Official title Treating Chronic Pain in Buprenorphine Patients in Primary Care Settings
Principal investigator Michael Stein, MD
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Butler Hospital.