Cessation of Long-term Opioid Therapy in Chronic Pain Patients

NCT ID: NCT02132221

Last Updated: 2019-03-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2015-01-31

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.

Conditions

Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cognitive Behavioral Therapy (CBT)

cognitive therapy (10 weekly sessions)

Group Type: EXPERIMENTAL

Cognitive Behavioral Therapy

Intervention Type: 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.

no CBT- wait list

no cognitive therapy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cognitive Behavioral Therapy

10- weekly 1h30 group sessions including psychoeducation and group discussions on pain, pain coping, opioid mechanisms, and relationship between mood, sleep, stress and pain.

Intervention Type: BEHAVIORAL

Other Intervention Names

CBT; Cognitive therapy; Cognitive therapy workshop

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

James P. Rathmell, MD

Chief, Division of Pain Medicine, Department of Anesthesia, Critical Care and Pain Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James P Rathmell, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesia, Critical Care, Pain Medicine

Locations

Massachusetts General Hospital Center for Pain Medicine

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

Partners IRB 2013P000881

Identifier Type: -

Identifier Source: org_study_id