Chronic PainNCT02132221
Cessation of Long-term Opioid Therapy in Chronic Pain Patients
A study testing Cognitive Behavioral Therapy in people with Chronic Pain, run by Massachusetts General Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 12Show fewer
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital Center for Pain Medicine
Boston, Massachusetts, 02114
About this study
Official title: 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.
- Conditions
- Chronic Pain
- Being tested
- Cognitive Behavioral Therapy
- Keywords
- Chronic non cancer pain, Long term opioid therapy, Side effects, risks, function, negative benefit/risk ratio
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
Also called CBT, Cognitive therapy, Cognitive therapy workshop
10- weekly 1h30 group sessions including psychoeducation and group discussions on pain, pain coping, opioid mechanisms, and relationship between mood, sleep, stress and pain.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy (CBT) | Experimental | cognitive therapy (10 weekly sessions) Receives: Behavioral: Cognitive Behavioral Therapy |
| no CBT- wait list | No intervention | no cognitive therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with daily opioid dose below 50% of initial dose
successful taper
Measured: 10 weeks
signs of hyperalgesia on Quantitative Sensory Testing (QST)
evolution of QST scores following taper
Measured: 10 weeks
Secondary outcomes (10)
signs of hyperalgesia on QST
at 3 months follow-up from taper, evolution of hyperalgesia
Measured: 24 weeks
number of patients who are not prescribed opioids on daily basis ("full taper")
described as not taking opioids on a daily basis
Measured: within 10 weeks
Time to reach >50% taper.
time to reach 50% taper will eb recorded in all individuals
Measured: 24 weeks
Pain scores (Brief Pain Inventory)
Measured: 10 and 24 weeks
Absolute opioid dose reduction
calculation of absolute dose reduction
Measured: 10 and 24 weeks
Functional Impairment
Brief Pain Inventory Interference scale and National Institute of Health Patient Reported Outcomes Measurement Information System (PROMIS) scale
Measured: 10 and 24 weeks
Number of patients who reach a full taper amongst those having not reached this outcome at 10 weeks.
Measured: 24 weeks
Anxiety and depression (HADS).
Measured: 10 and 24 weeks
Withdrawal (COWS measure).
Measured: 10 and 24 weeks
Hedonic tone (SHAPS).
Measured: 10 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2014 (estimated)
- Study startOct 2013
- Primary completionNov 2014
- Study completionJan 2015
Why it stopped: Enrollment too slow given study timeline
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Responsible party
- Principal investigator, James P. Rathmell, MD, Massachusetts General Hospital
- Investigators
- James P Rathmell, MD, Principal investigator, Department of Anesthesia, Critical Care, Pain Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02132221
- Sponsor's protocol ID
- Partners IRB 2013P000881
- Status last verified
- Mar 2019
- First submitted
- 24 Oct 2013
- Last updated
- 8 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Opioid Therapy in Chronic Pain Patients: Investigation of Tapering Strategies and Impact on Hyperalgesia
- ClinicalTrials.gov ID
- NCT02132221
- Acronym / sponsor ID
- Partners IRB 2013P000881
- Conditions
- Chronic Pain
- Keywords
- Chronic non cancer pain, Long term opioid therapy, Side effects, risks, function, negative benefit/risk ratio
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment too slow given study timeline
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Study start
- Oct 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 7 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy (CBT) | Experimental | Behavioral: Cognitive Behavioral Therapycognitive therapy (10 weekly sessions) |
| no CBT- wait list | No intervention | –no cognitive therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral TherapyAlso: CBT, Cognitive therapy, Cognitive therapy workshop10- weekly 1h30 group sessions including psychoeducation and group discussions on pain, pain coping, opioid mechanisms, and relationship between mood, sleep, stress and pain. | Behavioural | Cognitive Behavioral Therapy (CBT) |
Primary outcome
Number of participants with daily opioid dose below 50% of initial dose
Time frame: 10 weeks
successful taper
signs of hyperalgesia on Quantitative Sensory Testing (QST)
Time frame: 10 weeks
evolution of QST scores following taper
10 secondary outcomes
signs of hyperalgesia on QST
Time frame: 24 weeks
number of patients who are not prescribed opioids on daily basis ("full taper")
Time frame: within 10 weeks
Time to reach >50% taper.
Time frame: 24 weeks
Pain scores (Brief Pain Inventory)
Time frame: 10 and 24 weeks
Absolute opioid dose reduction
Time frame: 10 and 24 weeks
Functional Impairment
Time frame: 10 and 24 weeks
Number of patients who reach a full taper amongst those having not reached this outcome at 10 weeks.
Time frame: 24 weeks
Anxiety and depression (HADS).
Time frame: 10 and 24 weeks
Withdrawal (COWS measure).
Time frame: 10 and 24 weeks
Hedonic tone (SHAPS).
Time frame: 10 and 24 weeks
Results and safety
The study was stopped early (reason given: Enrollment too slow given study timeline). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2019.
Related trials for Chronic Pain
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James P Rathmell, MD principal investigator
Department of Anesthesia, Critical Care, Pain Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy in people with Chronic Pain, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Enrollment too slow given study timeline). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with daily opioid dose below 50% of initial dose (time frame: 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2019.