Long Acting Buprenorphine Injection Compared to Sublingual Buprenorphine/Naloxone Films
- Registration Number
- NCT03744663
- Lead Sponsor
- Wake Forest University Health Sciences
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Subjects who present to the WFBMC Medication-Assisted-Therapy (MAT) clinic seeking OBOT.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Suboxone® SL 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. Sublocade® 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.
- Primary Outcome Measures
Name Time Method Number of Participants that Dropout during the first 28 days of Treatment first 28 days Number of participants that leave the study
Clinical Opiate Withdrawal Scale (COWS) scores trends 26 weeks Withdrawal symptoms scale- total score 0-48 with a lower score denoting no symptoms (better Outcomes) and higher score denoting more withdrawal symptoms
Subjective Opiate Withdrawal Scale (SOWS) score trends 26 weeks Participant survey for how they are feeling during withdrawal period, score range from 0 to 64. Low score denotes no/less perceived symptoms (better outcomes) and higher score denotes high/ more personal perceived symptoms.
Number of Weeks patients continued in treatment during trial period 26 weeks Retention in weeks
Number of participants that complete of the treatment phase 26 weeks Number of participants that complete the study
Percentage of negative urinary drug screens 26 weeks percentage of participants that have a negative drug screen
Liver enzyme values- Total Bilirubin 26 weeks Values of liver enzymes will be measured: Total Bilirubin. Values will be reported in mg/dL
Number of participants who did not complete the trial in their assigned group 26 weeks Total number of participants that changed arms
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
Number or patients still in medication assisted therapy (MAT) clinic 6 months after trial period ends. 6 months Number of patients still in MAT clinics at 6 months
Number of participants death 6 months Number of Participants deaths 6 months after initial participant consent is given.as measured by Vital Statistics database
- Secondary Outcome Measures
Name Time Method