Cocaine Abuse Clinical Trial
Official title:
A Phase 1, Multiple-dose, Parallel Group Study to Evaluate the Safety and Pharmacodynamic Effects of RDC-0313-buprenorphine (ALKS 33-BUP) Administered Alone and Co-administered With Cocaine to Opioid-experienced Cocaine Abusers
The purpose of this study is to assess the safety and tolerability of ALKS33-BUP when administered to opioid-experienced cocaine abusers.
There are no currently available pharmacologic treatments for cocaine abuse and/or
dependence and the unmet medical need is growing. In collaboration with the National
Institute on Drug Abuse (NIDA), Alkermes, Inc. is investigating a fixed-dose combination
product consisting of ALKS 33 (also referred to as RDC-0313) and buprenorphine (ALKS 33-BUP)
for the treatment of cocaine abuse and/or dependence (Grant Number R01DA031000).
This is a randomized, double-blind, placebo-controlled, parallel design inpatient study.
Eligibility will be established which includes responses to cocaine infusions at baseline,
prior to study drug administration. Approximately 30 opioid-experienced cocaine abusers will
be randomized 1:1:1 to receive study drug. Study drug will be administered once daily for 10
consecutive days. Pharmacodynamic assessments and drug-drug interactions will be closely
monitored during the study. Following study drug administration, subjects will receive
cocaine infusions to evaluate the effect of treatment on the subjective effects and the
PK/PD of cocaine. Subjects will be discharged from the clinical research unit 2 days after
the last infusion of cocaine. Subjects will return for follow-up between 7 and 14 days after
discharge. The full study will take subjects approximately 28 days, with 17 days of
inpatient stay.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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