XRB vs. SLB in Jail and at Re-entry: Pilot, Proof of Concept
Not yet recruiting
New York University School of Medicine
This is a pilot proof-of-concept randomized controlled trial, open-label and unblinded,
examining the feasibility and acceptability of Buprenorphine extended-release vs. daily
sublingual buprenorphine-naloxone for the treatment of opioid use disorder in jail and at
Long Acting Buprenorphine Injection Compared to Sublingual Buprenorphine/Naloxone Films
Not yet recruiting
Wake Forest University Health Sciences
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.
This is a Phase 3b, open-label study in patients that present to the ED for an opioid OD and
receive treatment with an opioid antagonist. The study is designed to determine effect of
SUBLOCADE on repeat overdose and death compared to historical control data.
The study will assess subjects that receive acute administration of SUBOXONE sublingual film
in the Emergency Department (ED) followed by SUBLOCADE administration in the ED and referral
to an affiliated outpatient treatment clinic, compared to historical control data from
electronic health records.
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