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

NCT00981617 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 406

Last updated 2011-08-23

No results posted yet for this study

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.

Conditions

  • Alcohol Dependence

Interventions

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

Sponsors & Collaborators

  • Alkermes, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00981617 on ClinicalTrials.gov