ALK33-005: A Study of ALKS33 (RDC-0313) in Adults With Alcohol Dependence
NCT ID: NCT00981617
Last Updated: 2011-08-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
406 participants
INTERVENTIONAL
2009-10-31
2010-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ALKS33 (RDC-0313) (1 mg)
1 mg ALKS33 (RDC-0313) provided as capsules for daily oral administration
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) provided as capsules for daily oral administration
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) provided as capsules for daily oral administration
ALKS33 (RDC-0313) (10 mg)
10 mg ALKS33 (RDC-0313) taken once daily for 12 weeks
Placebo
Matching placebo (capsules without active study drug) provided for daily oral administration
Placebo
Matching placebo taken once daily for 12 weeks
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Alkermes, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Alkermes Investigational Site
Salt Lake City, Utah, United States
Alkermes Investigational Site
Middleton, Wisconsin, United States
Countries
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References
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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.
Other Identifiers
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ALK33-005
Identifier Type: -
Identifier Source: org_study_id
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