Long Acting Buprenorphine Injection Compared to Sublingual Buprenorphine/Naloxone Films

Wake Forest University (WFU)

Status and phase: Withdrawn; Phase 2

Conditions: Opioid Use

Treatments: Drug: Sublocade®; Drug: Suboxone® SL

Study type: Interventional

Funder types: Other

Identifiers

NCT03744663

IRB00054516

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

0 participants in 2 patient groups

Suboxone® SL

Active Comparator group

Description:

Patients assigned to this group will continue with their already established dose of Suboxone ® SL films for 24 weeks along with weekly therapy.

Treatment:

Drug: Suboxone® SL

Sublocade®

Experimental group

Description:

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.

Treatment:

Drug: Sublocade®