Cessation of Long-term Opioid Therapy in Chronic Pain Patients
| Status: | Terminated |
|---|---|
| Conditions: | Cancer, Chronic Pain, Chronic Pain |
| Therapuetic Areas: | Musculoskeletal, Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/10/2019 |
| Start Date: | October 2013 |
| End Date: | January 2015 |
Long-term Opioid Therapy in Chronic Pain Patients: Investigation of Tapering Strategies and Impact on Hyperalgesia
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.
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.
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).
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