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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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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