Opioid Use Disorder Clinical Trial
Official title:
A Multicenter, Open-Label, Single Ascending-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Depot Buprenorphine (RBP-6000) in Opioid-Dependent Subjects
A multi-center, open-label, single ascending dose study to enroll opioid dependent treatment-seeking subjects. Subjects to be enrolled into 3 cohorts receiving low, medium and high doses of depot buprenorphine. A fourth cohort will be enrolled to evaluate the PK of RBP-6000 after receiving suboxone tablets for 7 days.
All subjects will undergo screening period of up to 7 days. Eligible subjects in Cohorts 1-3
will receive RBP-6000 doses on at the conclusion of screening. Subjects in Cohort 4 will
receive sublingual (SL) Suboxone for 7 days prior to receiving an injection of RBP-6000.
For all cohorts, subjects will be admitted to the clinic 2 days prior to beginning any
dosing, and will remain in the clinic through Day 21. Blood collection for hematology,
chemistry and serology analysis will be drawn at screening, and intermittently for safety
assessments during the study period. Subjects in Cohorts 1-3 will have a PK sample collected
pre-dose and serial PK collection post-dosing. Subjects in Cohort 4 will have daily PK
collections while admitted during Suboxone dosing and serially after RBP-6000
administration.
Subjects will return to the clinic for PK sample collection through Day 140 or until
buprenorphine concentrations fall below 100 pg/mL. Subjects will return to the clinic for
safety assessments through Day 150.
Subjects experiencing signs and symptoms of withdrawal prior to RBP-6000 during the
residential phase may receive non-opioid rescue medications. Subjects who experience signs
and symptoms of withdrawal may receive hydromorphone beginning on Day 11 if necessary.
Methadone dosing can begin, if clinically indicated, on Day 16 only for subjects who have
not been administered hydromorphone. Subjects will not be allowed to use buprenorphine at
any time during the study.
Subjects will also receive psychosocial and behavioral counseling as specified by the PI.
The End of Study visit will occur 1 week after Day 84 or 1 week after the monthly follow-up
visits after Day 84, given a subject's buprenorphine plasma concentration has fallen below
100 pg/mL. For subjects with plasma concentrations of buprenorphine above 100 pg/mL at Day
140, Day 150 will be the End of Study visit.
Subjects will not be enrolled into the next cohort until safety data for at least the first
6 subjects has been reviewed.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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