Cessation of Long-term Opioid Therapy in Chronic Pain Patients

Chronic Pain Clinical Trial

Official title:

Long-term Opioid Therapy in Chronic Pain Patients: Investigation of Tapering Strategies and Impact on Hyperalgesia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02132221
• Other study ID #: Partners IRB 2013P000881
• Status: Terminated
• Phase: N/A
• Start date: October 2013
• Est. completion date: January 2015

Study information

• Verified date: March 2019
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: January 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Chronic Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital Center for Pain Medicine	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with daily opioid dose below 50% of initial dose	successful taper	10 weeks
Primary	signs of hyperalgesia on Quantitative Sensory Testing (QST)	evolution of QST scores following taper	10 weeks
Secondary	signs of hyperalgesia on QST	at 3 months follow-up from taper, evolution of hyperalgesia	24 weeks
Secondary	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
Secondary	Time to reach >50% taper.	time to reach 50% taper will eb recorded in all individuals	24 weeks
Secondary	Pain scores (Brief Pain Inventory)		10 and 24 weeks
Secondary	Absolute opioid dose reduction	calculation of absolute dose reduction	10 and 24 weeks
Secondary	Functional Impairment	Brief Pain Inventory Interference scale and National Institute of Health Patient Reported Outcomes Measurement Information System (PROMIS) scale	10 and 24 weeks
Secondary	Number of patients who reach a full taper amongst those having not reached this outcome at 10 weeks.		24 weeks
Secondary	Anxiety and depression (HADS).		10 and 24 weeks
Secondary	Withdrawal (COWS measure).		10 and 24 weeks
Secondary	Hedonic tone (SHAPS).		10 and 24 weeks