Cessation of Long-term Opioid Therapy in Chronic Pain Patients

Study Overview
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Brief Summary
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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.

Official Title
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Long-term Opioid Therapy in Chronic Pain Patients: Investigation of Tapering Strategies and Impact on Hyperalgesia

Conditions
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Chronic Pain

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or Female, age above 18. Chronic non-cancer pain (pain for 6 or more months, current pain not attributed to a cancerous disease). Referrals to the Massachusetts General Hospital (MGH) Center for Pain Medicine for opioid taper. Chronic (more than 3 months) prescription of morphine, oxycodone, hydrocodone, hydromorphone, codeine or any formulation of these medications. Morphine dose equivalent of 60 mg or above. Opioid treatment has to be stable (plus or minus20%) over the last 3 months. Meeting Substance Abuse and Mental Health Services Administration (SAMHSA) criteria for exit from chronic opioid therapy Willingness to taper and participate in treatment as randomized (including cognitive workshop sessions), able to meet the protocol follow-up schedule and activities Agreement to undergo random urine toxicology assays, which will be recommended to prescribing physician during study. Agreement to sign an opioid contract, as recommended to prescribing physician. Informed consent to study (IRB approved informed Consent form). English Language Literacy. Exclusion Criteria: Methadone, suboxone or fentanyl patch: the tapering with these opioids would not be comparable to the other patients. As enrolment will be open during about 12 months, if a patient was motivated to participate in the study, they could be referred to the pain clinic for advice on a switch to a medication that could allow inclusion. They would, 3 months after this switch, become eligible for the study. Pregnancy. History of epilepsy and drug-induced seizures. Proof of current diversion of drugs or recent substance related legal problems (e.g. buying/selling on the streets). Concurrent use of illicit drugs and narcotics (urine toxicology), active diagnosis of substance abuse or dependence disorder within last 3 months. Absence of the prescribed drug in the urine toxicology Refusal of taper or dose reduction trial. Preference for suboxone or related treatments. Severe psychiatric condition and/or cognitive deficits limiting patient's ability to participate Involved in concurrent opioid management for an acute pain condition. Current suicidal ideation. Severe and unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological or hematological disease. General conditions that would impede participation in a group intervention, as assessed by evaluating physician (e.g. cognitive impairment, tendencies towards physical aggression).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive Behavioral Therapy (CBT)<br>cognitive therapy (10 weekly sessions) | Behavioral: Cognitive Behavioral Therapy<br>* 10- weekly 1h30 group sessions including psychoeducation and group discussions on pain, pain coping, opioid mechanisms, and relationship between mood, sleep, stress and pain.<br>* Other names: Cognitive therapy workshop;|
| No Intervention: no CBT- wait list<br>no cognitive therapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic non cancer pain, Long term opioid therapy, Side effects, risks, function, negative benefit/risk ratio