Assessing the Safety of Buprenorphine in People With Sickle Cell Disease

NCT03492099 | Completed Phase 2 Results FDA Drug

• 1 other identifier: IRB00159636
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Disease

Outcome Measures

Primary Outcomes (1)

• Number of Subjects Who Require Hospitalization Within 72 Hours Post Conversion From Full Agonist Opioids to Buprenorphine-based Pain Treatment

  Data will be collected on need for hospitalization within 72 hours of conversion due to withdrawal induced vaso-occlusive crisis (VOC). 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.

  72 hours after buprenorphine initiation

Secondary Outcomes (3)

• Change in the Number of Acute Care Visits Per Subject in the 6 Months Prior to Buprenorphine (BUP) Induction and in the 6 Months Post to BUP Induction

  6 months pre BUP induction, 6 months post BUP induction

• Change in Severity of Opiate Withdrawal, Based on the Clinical Opiate Withdrawal Scale (COWS) Score

  COWS score at BUP induction, COWS score at the end of the first day of induction

• Number of Participants Continuing Buprenorphine Therapy After 6 Months of Induction

  6 months after induction

Study Arms (1)

Buprenorphine Arm

EXPERIMENTAL

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

Interventions

buprenorphine DRUG

Patients in this study will receive dosages to be determined by a physician that are specific to each patient.

Also known as: Zubsolv, Suboxone, Buprenorphine Sublingual (SL)

Buprenorphine Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21205, United States

Location

Related Publications (4)

• Daitch D, Daitch J, Novinson D, Frey M, Mitnick C, Pergolizzi J Jr. Conversion from high-dose full-opioid agonists to sublingual buprenorphine reduces pain scores and improves quality of life for chronic pain patients. Pain Med. 2014 Dec;15(12):2087-94. doi: 10.1111/pme.12520. Epub 2014 Sep 12.

  PMID: 25220043 BACKGROUND

• Carroll CP, Lanzkron S, Haywood C Jr, Kiley K, Pejsa M, Moscou-Jackson G, Haythornthwaite JA, Campbell CM. Chronic Opioid Therapy and Central Sensitization in Sickle Cell Disease. Am J Prev Med. 2016 Jul;51(1 Suppl 1):S69-77. doi: 10.1016/j.amepre.2016.02.012.

  PMID: 27320469 BACKGROUND

• Platt OS, Thorington BD, Brambilla DJ, Milner PF, Rosse WF, Vichinsky E, Kinney TR. Pain in sickle cell disease. Rates and risk factors. N Engl J Med. 1991 Jul 4;325(1):11-6. doi: 10.1056/NEJM199107043250103.

  PMID: 1710777 BACKGROUND

• Wesson DR, Ling W. The Clinical Opiate Withdrawal Scale (COWS). J Psychoactive Drugs. 2003 Apr-Jun;35(2):253-9. doi: 10.1080/02791072.2003.10400007.

  PMID: 12924748 BACKGROUND

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Buprenorphine; Buprenorphine, Naloxone Drug Combination

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Naloxone; Drug Combinations; Pharmaceutical Preparations

Limitations and Caveats

The study was not randomized nor controlled. The participant pool was limited to those patients who consented to have their data reported; and among those prospectively enrolled, to those who accepted induction. In addition, not all inductions followed the same procedure. In particular, those that were performed inpatient might have a number of biases in patient selection and capacity to detect adverse events.

Results Point of Contact

• Title: Dr. Sophie Lanzkron
• Organization: Johns Hopkins University School of Medicine

slanzkr@jhmi.edu

4105028642

Study Officials

• Sophie Lanzkron, MD, MHS

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2018
• First Posted: April 10, 2018
• Study Start: August 1, 2018
• Primary Completion: September 23, 2019
• Study Completion: February 28, 2022
• Last Updated: April 25, 2022
• Results First Posted: October 1, 2020

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)