Cessation of Long-term Opioid Therapy in Chronic Pain Patients

NCT02132221 | Terminated

• 1 other identifier: Partners IRB 2013P000881
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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

Keywords

Chronic non cancer pain; Long term opioid therapy; Side effects; risks; function; negative benefit/risk ratio

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• signs of hyperalgesia on QST

  24 weeks

• number of patients who are not prescribed opioids on daily basis ("full taper")

  within 10 weeks

• Time to reach >50% taper.

  24 weeks

• Pain scores (Brief Pain Inventory)

  10 and 24 weeks

• Absolute opioid dose reduction

  10 and 24 weeks

Study Arms (2)

Cognitive Behavioral Therapy (CBT)

EXPERIMENTAL

cognitive therapy (10 weekly sessions)

Behavioral: Cognitive Behavioral Therapy

no CBT- wait list

NO INTERVENTION

no cognitive therapy

Interventions

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.

Also known as: CBT, Cognitive therapy, Cognitive therapy workshop

Cognitive Behavioral Therapy (CBT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Brigham and Women's Hospital: collaborator

Study Sites (1)

Massachusetts General Hospital Center for Pain Medicine

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• James P Rathmell, MD

  Department of Anesthesia, Critical Care, Pain Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Division of Pain Medicine, Department of Anesthesia, Critical Care and Pain Medicine

Study Record Dates

• First Submitted: October 24, 2013
• First Posted: May 7, 2014
• Study Start: October 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: January 1, 2015
• Last Updated: March 8, 2019

Record last verified: 2019-03

Locations

US (1)