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

Alcohol Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00981617
• Other study ID #: ALK33-005
• Status: Completed
• Phase: Phase 2
• First received: September 21, 2009
• Last updated: August 19, 2011
• Start date: October 2009
• Est. completion date: August 2010

Study information

• Verified date: August 2011
• Source: Alkermes, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 406
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism

Intervention

Drug:
• ALKS33 (RDC-0313) (1 mg)
1 mg ALKS33 (RDC-0313) taken once daily for 12 weeks
• ALKS33 (RDC-0313) (2.5 mg)
2.5 mg ALKS33 (RDC-0313) taken once daily for 12 weeks
• ALKS33 (RDC-0313) (10 mg)
10 mg ALKS33 (RDC-0313) taken once daily for 12 weeks
• Placebo
Matching placebo taken once daily for 12 weeks

Locations

Country	Name	City	State
United States	Alkermes Investigational Site	Albuquerque	New Mexico
United States	Alkermes Investigational Site	Atlanta	Georgia
United States	Alkermes Investigational Site	Atlanta	Georgia
United States	Alkermes Investigational Site	Brooklyn	New York
United States	Alkermes Investigational Site	Cerritos	California
United States	Alkermes Investigational Site	Charlotte	North Carolina
United States	Alkermes Investigational Site	Fall River	Massachusetts
United States	Alkermes Investigational site	Hickory	North Carolina
United States	Alkermes Investigational Site	Houston	Texas
United States	Alkermes Investigational Site	Jacksonville	Florida
United States	Alkermes Investigational Site	Lafayette	Indiana
United States	Alkermes Investigational Site	Las Vegas	Nevada
United States	Alkermes Investigational Site	Maitland	Florida
United States	Alkermes Investigational Site	Middleton	Wisconsin
United States	Alkermes Investigational Site	New Bern	North Carolina
United States	Alkermes Investigational Site	New York	New York
United States	Alkermes Investigational Site	Oceanside	California
United States	Alkermes Investigational Site	Oklahoma City	Oklahoma
United States	Alkermes Investigational Site	Orlando	Florida
United States	Alkermes Investigational Site	Philadelphia	Pennsylvania
United States	Alkermes Investigational Site	Pico Rivera	California
United States	Alkermes Investigational Site	Roswell	Georgia
United States	Alkermes Investigational Site	Salt Lake City	Utah
United States	Alkermes Investigational Site	San Diego	California
United States	Alkermes Investigational Site	South Miami	Florida
United States	Alkermes Investigational Site	Tucson	Arizona
United States	Alkermes Investigational Site	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Alkermes, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of subjects abstinent from heavy drinking		12 Weeks	No
Secondary	Percent of subjects abstinent from any drinking		12 Weeks	No
Secondary	Percent of days abstinent from heavy drinking		12 Weeks	No
Secondary	Percent of days abstinent from any alcohol		12 Weeks	No
Secondary	Number of drinks per drinking day		12 Weeks	No
Secondary	Days to relapse to first heavy drinking day		12 Weeks	No
Secondary	Incidence of Adverse Events		12 Weeks	Yes