Cessation of Long-term Opioid Therapy in Chronic Pain Patients

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Pain
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital Center for Pain Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cognitive Behavioral Therapy (CBT); cognitive therapy (10 weekly sessions)	Behavioral: 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.; Other Names: CBT; Cognitive therapy; Cognitive therapy workshop
No Intervention: no CBT- wait list; no cognitive therapy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Brigham and Women's Hospital
• Investigators: Principal Investigator: James P Rathmell, MD, Department of Anesthesia, Critical Care, Pain Medicine

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: October 24, 2013
• First Submitted That Met QC Criteria: May 5, 2014
• First Posted (Estimate): May 7, 2014

Study Record Updates

• Last Update Posted (Actual): March 8, 2019
• Last Update Submitted That Met QC Criteria: March 6, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: function; Side effects; risks; Chronic non cancer pain; Long term opioid therapy; negative benefit/risk ratio
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: Partners IRB 2013P000881