NCT00981617

ALK33-005: A Study of ALKS33 (RDC-0313) in Adults With Alcohol Dependence

A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Adaptive Study of the Safety and Efficacy of RDC-0313 in Adults With Alcohol Dependence

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 406 (actual)
• Sponsor: Alkermes, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the safety and efficacy of ALKS33 (RDC-0313) compared with placebo in adults with alcohol dependence. There will be 11 study visits conducted over a period of about 4 months. The study period includes a screening visit, a 12-week treatment period, and a follow-up visit.

Detailed description

This is a multi-center, randomized, double-blind, placebo-controlled study. A 3-stage adaptive design will be used. Following screening, eligible subjects will be randomized equally to 1 of 4 groups (ALKS33 \[RDC-0313\] \[1, 2.5, OR 10 mg\], or matching placebo).

Conditions

• Alcohol Dependence

Interventions

Type	Name	Description
DRUG	ALKS33 (RDC-0313) (1 mg)	1 mg ALKS33 (RDC-0313) taken once daily for 12 weeks
DRUG	ALKS33 (RDC-0313) (2.5 mg)	2.5 mg ALKS33 (RDC-0313) taken once daily for 12 weeks
DRUG	ALKS33 (RDC-0313) (10 mg)	10 mg ALKS33 (RDC-0313) taken once daily for 12 weeks
DRUG	Placebo	Matching placebo taken once daily for 12 weeks

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2009-09-22
• Last updated: 2011-08-23

Locations

27 sites across 1 country: United States