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Cessation of Long-term Opioid Therapy in Chronic Pain Patients

Primary Purpose

Chronic Pain

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Chronic non cancer pain, Long term opioid therapy, Side effects, risks, function, negative benefit/risk ratio

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Massachusetts General Hospital Center for Pain Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cognitive Behavioral Therapy (CBT)

no CBT- wait list

Arm Description

cognitive therapy (10 weekly sessions)

no cognitive therapy

Outcomes

Primary Outcome Measures

Number of participants with daily opioid dose below 50% of initial dose
successful taper
signs of hyperalgesia on Quantitative Sensory Testing (QST)
evolution of QST scores following taper

Secondary Outcome Measures

signs of hyperalgesia on QST
at 3 months follow-up from taper, evolution of hyperalgesia
number of patients who are not prescribed opioids on daily basis ("full taper")
described as not taking opioids on a daily basis
Time to reach >50% taper.
time to reach 50% taper will eb recorded in all individuals
Pain scores (Brief Pain Inventory)
Absolute opioid dose reduction
calculation of absolute dose reduction
Functional Impairment
Brief Pain Inventory Interference scale and National Institute of Health Patient Reported Outcomes Measurement Information System (PROMIS) scale
Number of patients who reach a full taper amongst those having not reached this outcome at 10 weeks.
Anxiety and depression (HADS).
Withdrawal (COWS measure).
Hedonic tone (SHAPS).

Full Information

First Posted
October 24, 2013
Last Updated
March 6, 2019
Sponsor
Massachusetts General Hospital
Collaborators
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02132221
Brief Title
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

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Terminated
Why Stopped
Enrollment too slow given study timeline
Study Start Date
October 2013 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Brigham and Women's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Chronic non cancer pain, Long term opioid therapy, Side effects, risks, function, negative benefit/risk ratio

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavioral Therapy (CBT)
Arm Type
Experimental
Arm Description
cognitive therapy (10 weekly sessions)
Arm Title
no CBT- wait list
Arm Type
No Intervention
Arm Description
no cognitive therapy
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Other Intervention Name(s)
CBT, Cognitive therapy, Cognitive therapy workshop
Intervention Description
10- weekly 1h30 group sessions including psychoeducation and group discussions on pain, pain coping, opioid mechanisms, and relationship between mood, sleep, stress and pain.
Primary Outcome Measure Information:
Title
Number of participants with daily opioid dose below 50% of initial dose
Description
successful taper
Time Frame
10 weeks
Title
signs of hyperalgesia on Quantitative Sensory Testing (QST)
Description
evolution of QST scores following taper
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
signs of hyperalgesia on QST
Description
at 3 months follow-up from taper, evolution of hyperalgesia
Time Frame
24 weeks
Title
number of patients who are not prescribed opioids on daily basis ("full taper")
Description
described as not taking opioids on a daily basis
Time Frame
within 10 weeks
Title
Time to reach >50% taper.
Description
time to reach 50% taper will eb recorded in all individuals
Time Frame
24 weeks
Title
Pain scores (Brief Pain Inventory)
Time Frame
10 and 24 weeks
Title
Absolute opioid dose reduction
Description
calculation of absolute dose reduction
Time Frame
10 and 24 weeks
Title
Functional Impairment
Description
Brief Pain Inventory Interference scale and National Institute of Health Patient Reported Outcomes Measurement Information System (PROMIS) scale
Time Frame
10 and 24 weeks
Title
Number of patients who reach a full taper amongst those having not reached this outcome at 10 weeks.
Time Frame
24 weeks
Title
Anxiety and depression (HADS).
Time Frame
10 and 24 weeks
Title
Withdrawal (COWS measure).
Time Frame
10 and 24 weeks
Title
Hedonic tone (SHAPS).
Time Frame
10 and 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James P Rathmell, MD
Organizational Affiliation
Department of Anesthesia, Critical Care, Pain Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital Center for Pain Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

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Cessation of Long-term Opioid Therapy in Chronic Pain Patients

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