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

Butler Hospital

Status: Completed

Conditions: Substance Use; Depression; Pain

Treatments: Behavioral: Treating Opioid Patients' Pain and Sadness (TOPPS); Behavioral: Health Education

Study type: Interventional

Funder types: Other

Identifiers

NCT01752998

1205-002 (Other Identifier)

DA032800

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups, including a placebo group

TOPPS Intervention

Active Comparator group

Description:

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.

Treatment:

Behavioral: Treating Opioid Patients' Pain and Sadness (TOPPS)

Health Education

Placebo Comparator group

Description:

Individuals randomized into this arm will receive 7 individual sessions on general health education.

Treatment:

Behavioral: Health Education