Long Acting Buprenorphine Injection Compared to Sublingual Buprenorphine/Naloxone Films

NCT ID: NCT03744663

Last Updated: 2022-06-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-30
• Study Completion Date: 2022-12-31

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.

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.

Conditions

Opioid Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Suboxone® SL

Intervention Type: DRUG

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.

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.

Group Type: EXPERIMENTAL

Sublocade®

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Suboxone® SL films; buprenorphine naloxone; buprenorphine extended-release

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erin Barnes, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

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Other Identifiers

IRB00054516

Identifier Type: -

Identifier Source: org_study_id