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

Completed · Phase 2 · Has a placebo group

Conditions studied: Alcohol Dependence

In brief

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.

Key facts

Study ID

NCT00981617

Run by

Alkermes, Inc.

People needed

406

Starts

2009-10-01

Expected to finish

2010-08-01

Last updated by the study team

2011-08-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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