Long Acting Buprenorphine Injection Compared to Sublingual Buprenorphine/Naloxone Films
| Status: | Not yet recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/8/2019 |
| Start Date: | March 2019 |
| End Date: | November 2019 |
| Contact: | Ernesto L. Aranda-Aguirre, MD |
| Email: | earandaa@wakehealth.edu |
| Phone: | 3367162700 |
A Randomized Pilot Study of Long Acting Buprenorphine Injection Compared to Sublingual Buprenorphine/Naloxone Films
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.
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.
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.
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
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