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

Phase 2

Completed

• Conditions: Alcohol Dependence
• Interventions: Drug: ALKS33 (RDC-0313) (1 mg); Drug: ALKS33 (RDC-0313) (2.5 mg); Drug: ALKS33 (RDC-0313) (10 mg); Drug: Placebo

• Registration Number: NCT00981617
• Lead Sponsor: Alkermes, Inc.

Brief 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).

Study Timeline

• Study First Submitted: 2009-09-21
• Study First Submitted QC: 2009-09-21
• Study First Posted: 2009-09-22
• Study Start: 2009-10
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2011-08
• Disposition First Submitted: 2011-08-19
• Disposition First Submitted QC: 2011-08-19
• Last Update Submitted: 2011-08-19
• Disposition First Posted: 2011-08-23
• Last Update Posted: 2011-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 406

Inclusion Criteria

• 18 years of age or older
• Current diagnosis of alcohol dependence, with recent heavy drinking (eg, 5 drinks per day for men and 4 drinks per day for women)
• A noncustodial stable residence and a telephone
• Women having reproductive potential must agree to use an approved method of contraception for the duration of the study
• Ability to stop drinking prior to receiving study drug

Exclusion Criteria

• Pregnancy and/or current breastfeeding
• Past or present history of an AIDS-indicator disease
• Current dependence on any drugs (exclusive of nicotine, caffeine, or alcohol)
• Positive urine drug screen for benzodiazepines (unless used for a short-term basis during alcohol detoxification), opioids, amphetamines/ methamphetamines or cocaine at Visits 1 and 2
• Clinically significant medical condition
• Current or anticipated need for prescribed opioid medication during the study period
• Use of naltrexone within 60 days prior to screening
• Current need for antidepressants (within 30 days prior to entry)
• Participation in a clinical trial of a pharmacological agent within 30 days prior to screening
• Parole or probation or pending legal proceedings that have the potential for incarceration during the study period

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ALKS33 (RDC-0313) (1 mg)	ALKS33 (RDC-0313) (1 mg)	1 mg ALKS33 (RDC-0313) provided as capsules for daily oral administration
ALKS33 (RDC-0313) (2.5 mg)	ALKS33 (RDC-0313) (2.5 mg)	2.5 mg ALKS33 (RDC-0313) provided as capsules for daily oral administration
ALKS33 (RDC-0313) (10 mg)	ALKS33 (RDC-0313) (10 mg)	10 mg ALKS33 (RDC-0313) provided as capsules for daily oral administration
Placebo	Placebo	Matching placebo (capsules without active study drug) provided for daily oral administration

Primary Outcome Measures

Name	Time	Method
Percent of subjects abstinent from heavy drinking	12 Weeks

Secondary Outcome Measures

Name	Time	Method
Percent of subjects abstinent from any drinking	12 Weeks
Percent of days abstinent from heavy drinking	12 Weeks
Percent of days abstinent from any alcohol	12 Weeks
Number of drinks per drinking day	12 Weeks
Days to relapse to first heavy drinking day	12 Weeks
Incidence of Adverse Events	12 Weeks

Trial Locations

Locations (2)

Alkermes Investigational Site; 🇺🇸 Middleton, Wisconsin, United States

Alkermes Investigational site; 🇺🇸 Hickory, North Carolina, United States