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| Name | Class |
|---|---|
| Brigham and Women's Hospital | OTHER |
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This research is being done to better understand how to help patients who are not receiving enough relief from opioid prescription medications for chronic non-cancer pain. Opioids are a group of medications that includes morphine, oxycodone-, hydrocodone-, etc. These medications are also called narcotics. Research has shown that patients not benefiting from their opioid prescription medication often feel better when they stop taking it. However, stopping or reducing pain medications can be a difficult transition. Although they do not have much benefit from their medication, many patients are afraid to stop because they feel these medications are the only things giving them a bit of relief. Different strategies can be used to help patients through the period of tapering and it is not clear which one is best. The investigators will test a specific approach used during regular care in the clinic: cognitive therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Behavioral Therapy (CBT) | Experimental | cognitive therapy (10 weekly sessions) |
|
| no CBT- wait list | No Intervention | no cognitive therapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Behavioral Therapy | Behavioral | 10- weekly 1h30 group sessions including psychoeducation and group discussions on pain, pain coping, opioid mechanisms, and relationship between mood, sleep, stress and pain. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with daily opioid dose below 50% of initial dose | successful taper | 10 weeks |
| signs of hyperalgesia on Quantitative Sensory Testing (QST) | evolution of QST scores following taper | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| signs of hyperalgesia on QST | at 3 months follow-up from taper, evolution of hyperalgesia | 24 weeks |
| number of patients who are not prescribed opioids on daily basis ("full taper") | described as not taking opioids on a daily basis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James P Rathmell, MD | Department of Anesthesia, Critical Care, Pain Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital Center for Pain Medicine | Boston | Massachusetts | 02114 | United States |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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|
| within 10 weeks |
| Time to reach >50% taper. | time to reach 50% taper will eb recorded in all individuals | 24 weeks |
| Pain scores (Brief Pain Inventory) | 10 and 24 weeks |
| Absolute opioid dose reduction | calculation of absolute dose reduction | 10 and 24 weeks |
| Functional Impairment | Brief Pain Inventory Interference scale and National Institute of Health Patient Reported Outcomes Measurement Information System (PROMIS) scale | 10 and 24 weeks |
| Number of patients who reach a full taper amongst those having not reached this outcome at 10 weeks. | 24 weeks |
| Anxiety and depression (HADS). | 10 and 24 weeks |
| Withdrawal (COWS measure). | 10 and 24 weeks |
| Hedonic tone (SHAPS). | 10 and 24 weeks |