MedDataX Logo

Treating Chronic Pain in Buprenorphine Patients in Primary Care Settings

NCT ID: NCT01752998

Last Updated: 2017-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2017-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pain Depression Substance Use

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

TOPPS Intervention

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.

Group Type ACTIVE_COMPARATOR

Treating Opioid Patients' Pain and Sadness (TOPPS)

Intervention Type BEHAVIORAL

Health Education

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

Group Type PLACEBO_COMPARATOR

Health Education

Intervention Type BEHAVIORAL

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Treating Opioid Patients' Pain and Sadness (TOPPS)

Intervention Type BEHAVIORAL

Health Education

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Butler Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Michael Stein, MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michael Stein, MD

Role: PRINCIPAL_INVESTIGATOR

Butler Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Butler Hospital

Providence, Rhode Island, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1205-002

Identifier Type: OTHER

Identifier Source: secondary_id

DA032800

Identifier Type: -

Identifier Source: org_study_id