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Treating Chronic Pain in Buprenorphine Patients in Primary Care Settings

Treating Chronic Pain in Buprenorphine Patients in Primary Care Settings

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01752998
Acronym
BupPain
Enrollment
28
Registered
2012-12-19
Start date
2012-09-30
Completion date
2017-08-31
Last updated
2017-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression, Pain, Substance Use

Keywords

pain, depression, substance use

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.

Interventions

BEHAVIORALHealth Education

Sponsors

Butler Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
Pain4 monthsPain, as measured by self-report

Secondary

MeasureTime frameDescription
Depression4 monthsDepression, as measured by self-report and clinician-administered assessments
Substance Use4 monthsIllicit substance use, as measured by self-report and urine toxicology

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026