Clinical trial NCT03744663: Long Acting Buprenorphine Injection Compared to Sublingual Buprenorphine/Naloxone Films
Official title: A Randomized Pilot Study of Long Acting Buprenorphine Injection Compared to Sublingual Buprenorphine/Naloxone Films
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Opioid Use
Keywords: opioid
Opioid Agonist Treatment
buprenorphine
substance abuse
drug
abstinence
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2018-11-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Subjects who present to the WFBMC Medication-Assisted-Therapy (MAT) clinic seeking OBOT.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of Weeks patients continued in treatment during trial period
timeFrame: 26 weeks
measure: Number of Participants that Dropout during the first 28 days of Treatment
timeFrame: first 28 days
measure: Number of participants that complete of the treatment phase
timeFrame: 26 weeks
measure: Number of participants who did not complete the trial in their assigned group
timeFrame: 26 weeks
measure: Percentage of negative urinary drug screens
timeFrame: 26 weeks
measure: Liver enzyme values - ALP, AST, ALT
timeFrame: 26 weeks
measure: Liver enzyme values- Total Bilirubin
timeFrame: 26 weeks
measure: Clinical Opiate Withdrawal Scale (COWS) scores trends
timeFrame: 26 weeks
measure: Subjective Opiate Withdrawal Scale (SOWS) score trends
timeFrame: 26 weeks
measure: Number or patients still in medication assisted therapy (MAT) clinic 6 months after trial period ends.
timeFrame: 6 months
measure: Number of participants death
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wake Forest University Health Sciences
name: Erin Barnes, MD
role: PRINCIPAL_INVESTIGATOR
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