A Randomized Pilot Study of Long Acting Buprenorphine Injection Compared to Sublingual Buprenorphine/Naloxone Films

NCT03744663 Phase 2 WITHDRAWN

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.

Details

Lead sponsor	Wake Forest University Health Sciences
Phase	Phase 2
Status	WITHDRAWN
Start date	2022-06
Completion	2022-12

Conditions

• Opioid Use

Interventions

• Suboxone® SL
• Sublocade®

Primary outcomes

• Number of Weeks patients continued in treatment during trial period — 26 weeks
  Retention in weeks
• Number of Participants that Dropout during the first 28 days of Treatment — first 28 days
  Number of participants that leave the study
• Number of participants that complete of the treatment phase — 26 weeks
  Number of participants that complete the study
• Number of participants who did not complete the trial in their assigned group — 26 weeks
  Total number of participants that changed arms
• Percentage of negative urinary drug screens — 26 weeks
  percentage of participants that have a negative drug screen
• Liver enzyme values - ALP, AST, ALT — 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