Treating Chronic Pain in Buprenorphine Patients in Primary Care Settings

Depression Clinical Trial

— BupPain  

Official title:

Treating Chronic Pain in Buprenorphine Patients in Primary Care Settings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01752998
• Other study ID #: DA032800
• Secondary ID: 1205-002
• Status: Completed
• Phase: N/A
• First received: December 17, 2012
• Last updated: September 15, 2017
• Start date: September 2012
• Est. completion date: August 2017

Study information

• Verified date: September 2017
• Source: Butler Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Depression
• Pain
• Substance Use

Intervention

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

• Health Education

Locations

Country	Name	City	State
United States	Butler Hospital	Providence	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Butler Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	Pain, as measured by self-report	4 months
Secondary	Depression	Depression, as measured by self-report and clinician-administered assessments	4 months
Secondary	Substance Use	Illicit substance use, as measured by self-report and urine toxicology	4 months