Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Alkermes, Inc.
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).
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
