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

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.

Study Overview

• Status: Completed
• Conditions: Alcohol Dependence
• Intervention / Treatment: Drug: ALKS33 (RDC-0313) (1 mg); Drug: ALKS33 (RDC-0313) (2.5 mg); Drug: ALKS33 (RDC-0313) (10 mg); Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 406
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85712
      • Alkermes Investigational Site
  • California
    • Cerritos, California, United States, 90703
      • Alkermes Investigational Site
    • Oceanside, California, United States, 92056
      • Alkermes Investigational Site
    • Pico Rivera, California, United States, 90660
      • Alkermes Investigational Site
    • San Diego, California, United States, 92102
      • Alkermes Investigational Site
  • Florida
    • Jacksonville, Florida, United States, 32216
      • Alkermes Investigational Site
    • Maitland, Florida, United States, 32751
      • Alkermes Investigational Site
    • Orlando, Florida, United States, 32806
      • Alkermes Investigational Site
    • South Miami, Florida, United States, 33143
      • Alkermes Investigational Site
    • West Palm Beach, Florida, United States, 33407
      • Alkermes Investigational Site
  • Georgia
    • Atlanta, Georgia, United States, 30320
      • Alkermes Investigational Site
    • Atlanta, Georgia, United States, 30328
      • Alkermes Investigational Site
    • Roswell, Georgia, United States, 30076
      • Alkermes Investigational Site
  • Indiana
    • Lafayette, Indiana, United States, 47905
      • Alkermes Investigational Site
  • Massachusetts
    • Fall River, Massachusetts, United States, 02720
      • Alkermes Investigational Site
  • Nevada
    • Las Vegas, Nevada, United States, 89146
      • Alkermes Investigational Site
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Alkermes Investigational Site
  • New York
    • Brooklyn, New York, United States, 11235
      • Alkermes Investigational Site
    • New York, New York, United States, 10010
      • Alkermes Investigational Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28209
      • Alkermes Investigational Site
    • Hickory, North Carolina, United States, 28601
      • Alkermes Investigational Site
    • New Bern, North Carolina, United States, 28562
      • Alkermes Investigational Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • Alkermes Investigational Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19118
      • Alkermes Investigational Site
  • Texas
    • Houston, Texas, United States, 77090
      • Alkermes Investigational Site
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Alkermes Investigational Site
  • Wisconsin
    • Middleton, Wisconsin, United States, 53562
      • Alkermes Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ALKS33 (RDC-0313) (1 mg); 1 mg ALKS33 (RDC-0313) provided as capsules for daily oral administration	Drug: ALKS33 (RDC-0313) (1 mg); 1 mg ALKS33 (RDC-0313) taken once daily for 12 weeks
Experimental: ALKS33 (RDC-0313) (2.5 mg); 2.5 mg ALKS33 (RDC-0313) provided as capsules for daily oral administration	Drug: ALKS33 (RDC-0313) (2.5 mg); 2.5 mg ALKS33 (RDC-0313) taken once daily for 12 weeks
Experimental: ALKS33 (RDC-0313) (10 mg); 10 mg ALKS33 (RDC-0313) provided as capsules for daily oral administration	Drug: ALKS33 (RDC-0313) (10 mg); 10 mg ALKS33 (RDC-0313) taken once daily for 12 weeks
Placebo Comparator: Placebo; Matching placebo (capsules without active study drug) provided for daily oral administration	Drug: Placebo; Matching placebo taken once daily for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent of subjects abstinent from heavy drinking	12 Weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Alkermes, Inc.

Publications and helpful links

General Publications

• O'Malley SS, Todtenkopf MS, Du Y, Ehrich E, Silverman BL. Effects of the Opioid System Modulator, Samidorphan, on Measures of Alcohol Consumption and Patient-Reported Outcomes in Adults with Alcohol Dependence. Alcohol Clin Exp Res. 2018 Oct;42(10):2011-2021. doi: 10.1111/acer.13849. Epub 2018 Aug 13.

Study record dates

Study Major Dates

• Study Start: October 1, 2009
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: September 21, 2009
• First Submitted That Met QC Criteria: September 21, 2009
• First Posted (Estimate): September 22, 2009

Study Record Updates

• Last Update Posted (Estimate): August 23, 2011
• Last Update Submitted That Met QC Criteria: August 19, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Alcoholism; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Narcotic Antagonists; ALKS-33
• Other Study ID Numbers: ALK33-005