Rapid outpatient low-dose initiation of buprenorphine for individuals with OUD using fentanyl (ROLDI)
Brief description of study
If you are struggling with illicit fentanyl use, a new clinical research study is available for you. The purpose of this research study is to determine whether a new approach to starting buprenorphine ("Suboxone") has less withdrawal than the standard approach. This new approach is called rapid low dose initiation.
Another purpose of this study is to determine if participants continue opioid abstinence and medication treatment. Participants will be randomly assigned to the low dose group or the standard initiation group. They will receive buprenorphine over 2-day inpatient stay at HUP Cedar. We will measure withdrawal symptoms and follow up with patients 14 days later via phone call to see if patients continued buprenorphine treatment.
Detailed description of study
What medications are being used? In this clinical research study, you will receive buprenorphine either after at least 8 hours of abstinence (standard initiation) once moderate withdrawal symptoms set in, or as soon as you are admitted to the inpatient clinic (low dosing). The low-dosing approach does not require for a participant to be in withdrawal and participants will be started on a very small dose of buprenorphine that will be gradually increased over 10 hours to avoid precipitated withdrawal. Buprenorphine is an FDA approved medication used to treat opioid use disorder. Throughout the duration of the study, you will be under a doctor's care.
How long will I be involved? The duration for one participant is approximately 14 days. This consists of a screening visit (or 2), two days of inpatient detox at HUP Cedar, and a phone call 14 days after you've completed the treatment. During the screening phase you are asked to come to the Treatment Research Center go through a consent process, medical and psychiatric screening. During the detox phase, you are asked to stay at HUP Cedar for two days.
Will I have to pay for my participation? No! There is no charge for medical care, buprenorphine or laboratory services you will receive in this study. Other diagnostic or treatment services that you may decide to seek outside of the research study will not be covered by the research study or the University of Pennsylvania.
Will I receive compensation? Yes! You will be compensated for each visit that you attend and complete. Maximum compensation for completing the study is $135.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Buprenorphine,Opioid Use Disorder,Suboxone
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Age: 18 years - 99 years
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Gender: All
Inclusion Criteria:
- 18 or older
- Using fentanyl
- Interested in starting buprenorphine/Suboxone
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