Status:
COMPLETED
ALK33-005: A Study of ALKS33 (RDC-0313) in Adults With Alcohol Dependence
Lead Sponsor:
Alkermes, Inc.
Conditions:
Alcohol Dependence
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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. ...
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 (...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
406 Patients enrolled
Trial Details
Trial ID
NCT00981617
Start Date
October 1 2009
End Date
August 1 2010
Last Update
August 23 2011
Active Locations (27)
Enter a location and click search to find clinical trials sorted by distance.
1
Alkermes Investigational Site
Tucson, Arizona, United States, 85712
2
Alkermes Investigational Site
Cerritos, California, United States, 90703
3
Alkermes Investigational Site
Oceanside, California, United States, 92056
4
Alkermes Investigational Site
Pico Rivera, California, United States, 90660