Long Acting Buprenorphine Injection Compared to Sublingual Buprenorphine/Naloxone Films

• Status: Suspended
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wake Forest University Health Sciences
• Treatments: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone

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