Long Acting Buprenorphine Injection Compared to Sublingual Buprenorphine/Naloxone Films
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|ClinicalTrials.gov Identifier: NCT03744663|
Recruitment Status : Not yet recruiting
First Posted : November 16, 2018
Last Update Posted : October 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Opioid Use||Drug: Suboxone® SL Drug: Sublocade®||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Patients admitted to the WFBMC Medication-Assisted-Therapy (MAT) clinic with a diagnosis of moderate/severe Opioid-Use Disorders (OUD) who are more than 18 years old will be approached for enrollment in this study. Because of the nature of a pilot study, it's proposed a total of 30 patients, 15 in each group. Subjects will be started and titrated to optimal Suboxone® SL dose for 14 days. After the 14 day, the subject will be started on the treatment to which they are randomized, either Suboxone® SL or Sublocade®. Control group -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. Study drug-Sublocade® group: Patients assigned to this group will receive the study drug (subcutaneously) every 4 weeks for a total of 6 doses along with weekly therapy. At the end of the 24-weeks subjects will continue the medication of their choice within the constraints of their insurance provider.|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Pilot Study of Long Acting Buprenorphine Injection Compared to Sublingual Buprenorphine/Naloxone Films|
|Estimated Study Start Date :||November 2019|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||March 2020|
Active Comparator: 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.
Drug: Suboxone® SL
Subjects will be started and titrated to optimal Suboxone® SL dose for 14 days. After the 14 day induction phase, the subject will be started on the treatment to which they were randomized to two groups one of which will be Suboxone® SL.
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.
Subjects will be started and titrated to optimal Suboxone® SL dose for 14 days. After the 14 day induction phase, the subject will be started on the treatment to which they were randomized, either Suboxone® SL or Sublocade®. Subjects with significant opioid craving (> 20 mm on the Opioid Craving Visual Analog Scale) or withdrawal (a score of > 12 on the Clinical Opiate Withdrawal Scale) after 14 days of treatment will be started on Sublocade® only at the consensus of the research team. Otherwise they will undergo an additional 7 day titration period. Study drug with Sublocade® group: Patients assigned to this group will receive the study drug (300 mg subcutaneously) every 4 weeks for a total of 6 doses along with weekly therapy. The location and specifications of its application will follow the recommendations by the FDA previously published.
Other Name: buprenorphine extended-release
- Number of Weeks patients continued in treatment during trial period [ Time Frame: 26 weeks ]Retention in weeks
- Number of Participants that Dropout during the first 28 days of Treatment [ Time Frame: first 28 days ]Number of participants that leave the study
- Number of participants that complete of the treatment phase [ Time Frame: 26 weeks ]Number of participants that complete the study
- Number of participants who did not complete the trial in their assigned group [ Time Frame: 26 weeks ]Total number of participants that changed arms
- Percentage of negative urinary drug screens [ Time Frame: 26 weeks ]percentage of participants that have a negative drug screen
- Liver enzyme values - ALP, AST, ALT [ Time Frame: 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
- Liver enzyme values- Total Bilirubin [ Time Frame: 26 weeks ]Values of liver enzymes will be measured: Total Bilirubin. Values will be reported in mg/dL
- Clinical Opiate Withdrawal Scale (COWS) scores trends [ Time Frame: 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 [ Time Frame: 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 or patients still in medication assisted therapy (MAT) clinic 6 months after trial period ends. [ Time Frame: 6 months ]Number of patients still in MAT clinics at 6 months
- Number of participants death [ Time Frame: 6 months ]Number of Participants deaths 6 months after initial participant consent is given.as measured by Vital Statistics database
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03744663
|Contact: Ernesto L. Aranda-Aguirre, MDemail@example.com|
|Contact: Erin W. Barnes, MDfirstname.lastname@example.org|
|United States, North Carolina|
|Wake Forest Baptist Medical Center||Not yet recruiting|
|Winston-Salem, North Carolina, United States, 27157|
|Contact: Ernesto Aranda-Aguirre, MD email@example.com|
|Principal Investigator:||Erin Barnes, MD||Wake Forest University Health Sciences|