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Trial record 16 of 186 for:    BUPRENORPHINE AND NALOXONE

Long Acting Buprenorphine Injection Compared to Sublingual Buprenorphine/Naloxone Films

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ClinicalTrials.gov Identifier: NCT03744663
Recruitment Status : Not yet recruiting
First Posted : November 16, 2018
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Brief Summary:
While substance use disorders have been found to have relapse rates on part with other chronic illnesses such as hypertension and asthma long term abstinence remains elusive for many. The FDA has recently approve a long acting subcutaneous injectable formulation of buprenorphine. This study aims to determine the feasibility of enrolling and randomizing patients seeking treatment at an outpatient substance abuse clinic to buprenorphine/naloxone films which dissolve under the tongue vs. long acting buprenorphine injection with all other treatment aspects held constant. The study also aims to determine the effectiveness of monthly injections of Sublocade® compared to daily oral Suboxone® SL therapy in the treatment of moderate to severe opioid use disorder after twenty-four weeks of treatment.

Condition or disease Intervention/treatment Phase
Opioid Use Drug: Suboxone® SL Drug: Sublocade® Phase 2

Detailed Description:
While substance use disorders have been found to have relapse rates on part with other chronic illnesses such as hypertension and asthma long term abstinence remains elusive for many. Fortunately, the FDA has recently approved a long acting subcutaneous injectable formulation of buprenorphine. While this drug has proven effective in retaining patients in care and decreasing drug cravings as compared to placebo, this drug has not been tested in a real world clinic setting and no studies exist comparing it to the current formulations of buprenorphine. The objective of this study is to perform a randomized pilot study directly comparing sublingual buprenorphine/naloxone to long acting buprenorphine subdermal injection in a standard Office-Based Opioid Agonist Treatment (OBOT) clinic. The study team will compare patient retention, percentage of negative urinary drug screens, and withdrawal scores between the two groups. The findings will provide insight for US providers seeking more effective and efficient ways to treat Opioid use disorder (OUD) in the outpatient setting.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients admitted to the WFBMC Medication-Assisted-Therapy (MAT) clinic with a diagnosis of moderate/severe Opioid-Use Disorders (OUD) who are more than 18 years old will be approached for enrollment in this study. Because of the nature of a pilot study, it's proposed a total of 30 patients, 15 in each group. Subjects will be started and titrated to optimal Suboxone® SL dose for 14 days. After the 14 day, the subject will be started on the treatment to which they are randomized, either Suboxone® SL or Sublocade®. Control group -Suboxone®SL: Patients assigned to this group will continue with their already established dose of Suboxone ®SL films for 24 weeks along with weekly therapy. Study drug-Sublocade® group: Patients assigned to this group will receive the study drug (subcutaneously) every 4 weeks for a total of 6 doses along with weekly therapy. At the end of the 24-weeks subjects will continue the medication of their choice within the constraints of their insurance provider.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Pilot Study of Long Acting Buprenorphine Injection Compared to Sublingual Buprenorphine/Naloxone Films
Estimated Study Start Date : November 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Suboxone® SL
Patients assigned to this group will continue with their already established dose of Suboxone ® SL films for 24 weeks along with weekly therapy.
Drug: Suboxone® SL
Subjects will be started and titrated to optimal Suboxone® SL dose for 14 days. After the 14 day induction phase, the subject will be started on the treatment to which they were randomized to two groups one of which will be Suboxone® SL.
Other Names:
  • Suboxone® SL films
  • buprenorphine naloxone

Experimental: Sublocade®
Patients assigned to the Sublocade® group will receive the study drug (300 mg subcutaneously) every 4 weeks for a total of 6 doses along with weekly therapy.
Drug: Sublocade®
Subjects will be started and titrated to optimal Suboxone® SL dose for 14 days. After the 14 day induction phase, the subject will be started on the treatment to which they were randomized, either Suboxone® SL or Sublocade®. Subjects with significant opioid craving (> 20 mm on the Opioid Craving Visual Analog Scale) or withdrawal (a score of > 12 on the Clinical Opiate Withdrawal Scale) after 14 days of treatment will be started on Sublocade® only at the consensus of the research team. Otherwise they will undergo an additional 7 day titration period. Study drug with Sublocade® group: Patients assigned to this group will receive the study drug (300 mg subcutaneously) every 4 weeks for a total of 6 doses along with weekly therapy. The location and specifications of its application will follow the recommendations by the FDA previously published.
Other Name: buprenorphine extended-release




Primary Outcome Measures :
  1. Number of Weeks patients continued in treatment during trial period [ Time Frame: 26 weeks ]
    Retention in weeks

  2. Number of Participants that Dropout during the first 28 days of Treatment [ Time Frame: first 28 days ]
    Number of participants that leave the study

  3. Number of participants that complete of the treatment phase [ Time Frame: 26 weeks ]
    Number of participants that complete the study

  4. Number of participants who did not complete the trial in their assigned group [ Time Frame: 26 weeks ]
    Total number of participants that changed arms

  5. Percentage of negative urinary drug screens [ Time Frame: 26 weeks ]
    percentage of participants that have a negative drug screen

  6. Liver enzyme values - ALP, AST, ALT [ Time Frame: 26 weeks ]
    Values of liver enzymes will be measured: Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT). Values will be reported in IU/L

  7. Liver enzyme values- Total Bilirubin [ Time Frame: 26 weeks ]
    Values of liver enzymes will be measured: Total Bilirubin. Values will be reported in mg/dL

  8. Clinical Opiate Withdrawal Scale (COWS) scores trends [ Time Frame: 26 weeks ]
    Withdrawal symptoms scale- total score 0-48 with a lower score denoting no symptoms (better Outcomes) and higher score denoting more withdrawal symptoms

  9. Subjective Opiate Withdrawal Scale (SOWS) score trends [ Time Frame: 26 weeks ]
    Participant survey for how they are feeling during withdrawal period, score range from 0 to 64. Low score denotes no/less perceived symptoms (better outcomes) and higher score denotes high/ more personal perceived symptoms.

  10. Number or patients still in medication assisted therapy (MAT) clinic 6 months after trial period ends. [ Time Frame: 6 months ]
    Number of patients still in MAT clinics at 6 months

  11. Number of participants death [ Time Frame: 6 months ]
    Number of Participants deaths 6 months after initial participant consent is given.as measured by Vital Statistics database



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:

  • Subjects who present to the WFBMC Medication-Assisted-Therapy (MAT) clinic seeking OBOT.

Exclusion Criteria:

  • Those patients who have:
  • history of cirrhosis, >= CKD stage 3
  • congenital long QT syndrome
  • those on antiarrhythmic medications
  • liver enzymes more than 2 times the upper normal value at baseline assessment
  • elevated bilirubin
  • chronic pulmonary condition
  • current unstable and untreated psychiatry comorbid disorder
  • pregnant
  • use of benzodiazepines/other CNS depressant medications

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): NCT03744663


Contacts
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Contact: Ernesto L. Aranda-Aguirre, MD 3367162700 earandaa@wakehealth.edu
Contact: Erin W. Barnes, MD 3367167420 ewbarnes@wakehealth.edu

Locations
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United States, North Carolina
Wake Forest Baptist Medical Center Not yet recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Ernesto Aranda-Aguirre, MD       earandaa@wakehealth.edu   
Sponsors and Collaborators
Wake Forest University Health Sciences
Investigators
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Principal Investigator: Erin Barnes, MD Wake Forest University Health Sciences

Publications:
Prevention CfDCa. Heroin Overdose Data. US Department of Health and Human Services. https://www.cdc.gov/drugoverdose/data/heroin.html. Published Jan 2017. Updated 2018-08-31T12:47:34Z. Accessed September 3 2018.
Winchell C. Cross-Discipline Team Leader Review and Summary Basis for Approval. In: Administration FD, ed: Federal Drug Administration; 2017.
(2017) USFDA. Press Announcements - FDA approves first once-monthly buprenorphine injection, a medication-assisted treatment option for opioid use disorder. 2018.
Surgeon General's Report: Facing Addiction in America. In: Services USDoHaH, ed. 200 Independence Avenue SW Washington DC 20201: U.S. Department of Health and Human Services; 2017.
Park-Lee E, Lipari RN, Hedden SL, Kroutil LA, Porter JD. Receipt of Services for Substance Use and Mental Health Issues Among Adults: Results from the 2016 National Survey on Drug Use and Health. In: CBHSQ Data Review. Rockville (MD): Substance Abuse and Mental Health Services Administration (US); September 2017:1-35.

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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03744663     History of Changes
Other Study ID Numbers: IRB00054516
First Posted: November 16, 2018    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Wake Forest University Health Sciences:
opioid
Opioid Agonist Treatment
buprenorphine
substance abuse
drug
abstinence
Additional relevant MeSH terms:
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Buprenorphine
Buprenorphine, Naloxone Drug Combination
Naloxone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists