PainBupPainNCT01752998
Treating Chronic Pain in Buprenorphine Patients in Primary Care Settings
A study testing Treating Opioid Patients' Pain and Sadness (TOPPS) and Health Education in people with Pain and Depression, run by Butler Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pain, Depression, Substance Use
- What is being tested?
- Treating Opioid Patients' Pain and Sadness (TOPPS) and Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Pain, Depression, Substance Use
- Being tested
- Treating Opioid Patients' Pain and Sadness (TOPPS), Health Education
- Keywords
- pain, depression, substance use
- Medical subject headings
- Pain, Depression, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treating Opioid Patients' Pain and Sadness (TOPPS)Behavioural
Health EducationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| TOPPS Intervention | Active comparator | 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. Receives: Behavioral: Treating Opioid Patients' Pain and Sadness (TOPPS) |
| Health Education | Placebo comparator | Individuals randomized into this arm will receive 7 individual sessions on general health education. Receives: Behavioral: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Pain, as measured by self-report
Measured: 4 months
Secondary outcomes (2)
Depression
Depression, as measured by self-report and clinician-administered assessments
Measured: 4 months
Substance Use
Illicit substance use, as measured by self-report and urine toxicology
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2012 (estimated)
- Study startSep 2012
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Stein, MD, Butler Hospital
- Investigators
- Michael Stein, MD, Principal investigator, Butler Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01752998
- Sponsor's protocol ID
- DA032800
- Other IDs
- 1205-002
- Acronym
- BupPain
- Status last verified
- Sep 2017
- First submitted
- 17 Dec 2012
- Last updated
- 18 Sep 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Chronic Pain in Buprenorphine Patients in Primary Care Settings
- ClinicalTrials.gov ID
- NCT01752998
- Acronym / sponsor ID
- BupPain / DA032800
- Conditions
- Pain, Depression, Substance Use
- Keywords
- pain, depression, substance use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 19 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TOPPS Intervention | Active comparator | Behavioral: Treating Opioid Patients' Pain and Sadness (TOPPS)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. |
| Health Education | Placebo comparator | Behavioral: Health EducationIndividuals randomized into this arm will receive 7 individual sessions on general health education. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treating Opioid Patients' Pain and Sadness (TOPPS) | Behavioural | TOPPS Intervention |
| Health Education | Behavioural | Health Education |
Primary outcome
Pain
Time frame: 4 months
Pain, as measured by self-report
2 secondary outcomes
Depression
Time frame: 4 months
Substance Use
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Stein, MD principal investigator
Butler Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treating Opioid Patients' Pain and Sadness (TOPPS) and Health Education in people with Pain and Depression, run by Butler Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2017.