NCT01366001

ALK33BUP-101: Safety and Pharmacodynamic Effects of ALKS 33-BUP Administered Alone and When Co-administered With Cocaine

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Alkermes, Inc. · Industry
• Sex: All
• Age: 21 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety and tolerability of ALKS33-BUP when administered to opioid-experienced cocaine abusers.

Detailed description

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.

Conditions

• Cocaine Abuse

Interventions

Type	Name	Description
DRUG	ALKS 33-BUP	Sublingual administration, ALKS 33 + buprenorphine, administered once daily for 10 consecutive days.
DRUG	ALKS 33	Sublingual administration, ALKS 33 administered once daily for 10 consecutive days.
DRUG	Placebo	Sublingual administration, Placebo administered once daily for 10 consecutive days.

Timeline

• Start date: 2011-08-01
• Primary completion: 2012-02-01
• Completion: 2012-02-01
• First posted: 2011-06-03
• Last updated: 2012-03-09

Locations

1 site across 1 country: United States