A Phase 2 interventional study of Suboxone® SL and Sublocade® in Opioid Use, sponsored by Wake Forest University Health Sciences. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-06.
Sponsored by Wake Forest University Health Sciences · Phase 2, Interventional, and Treatment
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.
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.
Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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.
Drug: Sublocade®
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.
Also known as: Suboxone® SL films, buprenorphine naloxone
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.
Also known as: buprenorphine extended-release
Number of Weeks patients continued in treatment during trial period
Retention in weeks
Time frame: 26 weeks
Number of Participants that Dropout during the first 28 days of Treatment
Number of participants that leave the study
Time frame: first 28 days
Number of participants that complete of the treatment phase
Number of participants that complete the study
Time frame: 26 weeks
Number of participants who did not complete the trial in their assigned group
Total number of participants that changed arms
Time frame: 26 weeks
Percentage of negative urinary drug screens
percentage of participants that have a negative drug screen
Time frame: 26 weeks
Liver enzyme values - ALP, AST, ALT
Values of liver enzymes will be measured: Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT). Values will be reported in IU/L
Time frame: 26 weeks
Liver enzyme values- Total Bilirubin
Values of liver enzymes will be measured: Total Bilirubin. Values will be reported in mg/dL
Time frame: 26 weeks
Clinical Opiate Withdrawal Scale (COWS) scores trends
Withdrawal symptoms scale- total score 0-48 with a lower score denoting no symptoms (better Outcomes) and higher score denoting more withdrawal symptoms
Time frame: 26 weeks
Subjective Opiate Withdrawal Scale (SOWS) score trends
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.
Time frame: 26 weeks
Number or patients still in medication assisted therapy (MAT) clinic 6 months after trial period ends.
Number of patients still in MAT clinics at 6 months
Time frame: 6 months
Number of participants death
Number of Participants deaths 6 months after initial participant consent is given.as measured by Vital Statistics database
Time frame: 6 months
No study locations are listed for this record.
Plan to share: No
This study is withdrawn, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Wake Forest University Health Sciences