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Assessing the Safety of Buprenorphine in People With Sickle Cell Disease

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ClinicalTrials.gov Identifier: NCT03492099
Recruitment Status : Enrolling by invitation
First Posted : April 10, 2018
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
This study will assess the safety of changing pain medications (opioids) adult sickle cell patients take to another type of medication therapy (buprenorphine). Patients will be asked questions about their quality of life. Other tools for assessment will also be administered.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Drug: buprenorphine Phase 2

Detailed Description:

This is a descriptive, pilot study to assess the safety of converting a subset of adult sickle cell patients who are on effective disease modifying therapy (on high dose oral opioids who are unable to wean off opioids) and who continue to have frequent acute visits where parenteral opioids are administered to convert all opioid treatments to buprenorphine. Quality of life will be assessed using the Adult Sickle Cell Quality of life Measurement tool (ASCQ-Me), the Brief Pain Inventory (BPI), two Patient-Reported Outcomes Measurement Information System (PROMIS) surveys (short-form Pain Interference and Physical Function), and frequency of acute pain visits.

Buprenorphine is a partial mu-agonist and kappa antagonist and has a high affinity for the mu receptors with an elimination half-life of 28-37 hours for the sublingual administration. The lower risk for misuse, diminished withdrawal symptoms and cravings for opioids as well as the reduced risk of overdose make it an appealing alternative. Recent data on successful conversion for patients with chronic pain show a decrease in pain scores and increase in quality of life measurements after the beginning buprenorphine therapy for more than two months.

The first dose will be determined for each patient by a physician to ensure that the dosage of buprenorphine will be appropriate given the patient's current opioid dosage. There is the risk of withdrawal induced vaso-occlusive crisis (VOC).

Within 30 days prior to conversion to buprenorphine, a patient will take the ASCQ-Me, BPI, and two PROMIS surveys. Twenty-four hours prior to conversion, the patient will stop all opioid intake. The day of conversion, the patient will take a Clinical Opiate Withdrawal Scale (COWS) survey to determine whether they are in withdrawal. If so, the patient will begin buprenorphine conversion. They will also retake the aforementioned quality of life surveys. The patient will return on days 1, 14, 30, 90, and 180 to be evaluated.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessing the Safety of Buprenorphine in People With Sickle Cell Disease
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020


Arm Intervention/treatment
Experimental: Buprenorphine Arm
This is the main and only arm of the study. All patients in this arm will undergo the steps outlined in the protocol to convert to buprenorphine treatment.
Drug: buprenorphine
Patients in this study will receive dosages to be determined by a physician that are specific to each patient.
Other Names:
  • Zubsolv
  • Suboxone
  • Buprenorphine Sublingual (SL)




Primary Outcome Measures :
  1. Number of subjects who require hospitalization within 72 hours post conversion from full agonist opioids to buprenorphine-based pain treatment. [ Time Frame: 72 hours after buprenorphine initiation ]
    Data will be collected on need for hospitalization within 72 hours of conversion due to withdrawal induced vaso-occlusive crisis (VOC). Reported variables will be whether the patient was hospitalized within this window and for what reason the hospitalization occurred. If 2 out of the first 5 patients require hospitalization within 72 hours of conversion the study will be stopped and we will assess what changes need to be made in the protocol to decrease the risk of hospitalization triggered by the conversion.


Secondary Outcome Measures :
  1. Quality of life (Brief Pain Inventory) [ Time Frame: 6 months ]
    Measured by Brief Pain Inventory (BPI). The BPI measures how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. BPI pain interference is typically scored as the mean of the seven interference items. This mean can be used if more than 50%, or four of seven, of the total items have been completed on a given administration.

  2. Quality of life (PROMIS Pain Interference) [ Time Frame: 6 months ]
    Measurement of quality of life measured by Patient-Reported Outcomes Measurement Information System (PROMIS) - Pain Interference has 9 questions where responses vary from Not at all, A little bit, Somewhat, Quite a bit, and Very much. The lowest score is 9 and the the highest score is 45 with a higher score representing more pain interference.

  3. Quality of life (PROMIS Physical Function) [ Time Frame: 6 months ]
    Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) - Physical Function has 9 questions where responses vary from Not at all, A little bit, Somewhat, Quite a bit, and Very much. The lowest score is 9 and the the highest score is 45 with a higher score representing less physical function.

  4. Quality of life (ASCQ-Me) [ Time Frame: 6 months ]
    Measurement of quality of life measured by Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me). There are a fixed set of 5 items or questions for one domain. A unique aspect of ASCQ-Me measures is their use of standardized scores that are centered on a clinical population of people with sickle cell disease. Such scores are called "normative" because their value represents how close or far away they are from a normative population. The meaning of the score is defined by how it compares to the scores of others in a referent population. A score of 40 is one Standard Deviation lower than the mean of the reference population. A score of 60 is one Standard Deviation higher than the mean of the reference population

  5. Number of acute care visits required by subjects in the 6 months prior to initiation compared to the 6 months post conversion. [ Time Frame: 6 months prior to conversion, 6 months post-conversion ]
    Comparing number of acute care visits (either to Emergency Department or to Sickle Cell Infusion Center) in the six months prior to conversion to buprenorphine to 6 months post conversion.

  6. Severity of opiate withdrawal, based on COWS score. [ Time Frame: 24 hours after initiation ]
    All patients will be in opiate withdrawal at the time of buprenorphine initiation. The level of withdrawal will be measured by the Clinical Opiate Withdrawal Scale (COWS), an 11-item scale designed to be administered by a clinician. The score ranges from 0-4 (no withdrawal), 5-12 (mild withdrawal), 13-24 (moderate withdrawal), 25-36 (severe withdrawal), and 36-48 (most severe withdrawal). Each patient's COWS score at time of initiation and at 24 hours post initiation will be measured and reported.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Sickle Cell Disease, any genotype
  • On disease modifying therapy (either chronic transfusions or hydroxyurea)
  • On chronic daily full agonist opioid therapy with doses ranging from 90 to 400 morphine equivalents
  • Have greater than 5 acute care visits in the last 6 months or have daily pain of 7 or higher on the Visual Analog Scale despite chronic opioid therapy.
  • Able to provide consent
  • Has medical insurance

Exclusion Criteria:

  • Acute vaso-occlusive crisis on day of or day prior to buprenorphine initiation
  • Use of methadone as long acting opioid (due to prolonged half-life and limited data in other populations)
  • Use of illicit drugs as documented by urine toxicology screen (except for THC)
  • Pregnancy
  • Acute or severe bronchial asthma
  • Hypersensitivity to buprenorphine or any component of the product
  • Medical disorder, condition, or history that in the investigator's judgement would impair the patient's ability to participate or complete this study or render the patient to be inappropriate for enrollment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03492099


Locations
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United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Sophie Lanzkron, MD, MHS Johns Hopkins University

Publications:
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03492099     History of Changes
Other Study ID Numbers: IRB00159636
First Posted: April 10, 2018    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Data will be published at some point in the future but individual data will not be disclosed

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Hematologic Diseases
Genetic Diseases, Inborn
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hemoglobinopathies
Buprenorphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists