Clinical trial NCT02132221: Cessation of Long-term Opioid Therapy in Chronic Pain Patients
Official title: Long-term Opioid Therapy in Chronic Pain Patients: Investigation of Tapering Strategies and Impact on Hyperalgesia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Pain
Keywords: Chronic non cancer pain
Long term opioid therapy
Side effects
risks
function
negative benefit/risk ratio
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Brigham and Women's Hospital
First posted: 2014-05-07
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Number of participants with daily opioid dose below 50% of initial dose
timeFrame: 10 weeks
measure: signs of hyperalgesia on Quantitative Sensory Testing (QST)
timeFrame: 10 weeks
Secondary outcomes:
measure: signs of hyperalgesia on QST
timeFrame: 24 weeks
measure: number of patients who are not prescribed opioids on daily basis ("full taper")
timeFrame: within 10 weeks
measure: Time to reach >50% taper.
timeFrame: 24 weeks
measure: Pain scores (Brief Pain Inventory)
timeFrame: 10 and 24 weeks
measure: Absolute opioid dose reduction
timeFrame: 10 and 24 weeks
measure: Functional Impairment
timeFrame: 10 and 24 weeks
measure: Number of patients who reach a full taper amongst those having not reached this outcome at 10 weeks.
timeFrame: 24 weeks
measure: Anxiety and depression (HADS).
timeFrame: 10 and 24 weeks
measure: Withdrawal (COWS measure).
timeFrame: 10 and 24 weeks
measure: Hedonic tone (SHAPS).
timeFrame: 10 and 24 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital Center for Pain Medicine
state: Massachusetts
Study officials:
affiliation: Department of Anesthesia, Critical Care, Pain Medicine
name: James P Rathmell, MD
role: PRINCIPAL_INVESTIGATOR
References: