Alcohol Dependence
Conditions
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. The study period includes a screening visit, a 12-week treatment period, and a follow-up visit.
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 (ALKS33 \[RDC-0313\] \[1, 2.5, OR 10 mg\], or matching placebo).
Interventions
DRUGALKS33 (RDC-0313) (1 mg)
1 mg ALKS33 (RDC-0313) taken once daily for 12 weeks
DRUGALKS33 (RDC-0313) (2.5 mg)
2.5 mg ALKS33 (RDC-0313) taken once daily for 12 weeks
DRUGALKS33 (RDC-0313) (10 mg)
10 mg ALKS33 (RDC-0313) taken once daily for 12 weeks
DRUGPlacebo
Matching placebo taken once daily for 12 weeks
Sponsors
Alkermes, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent of subjects abstinent from heavy drinking | 12 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| Percent of days abstinent from heavy drinking | 12 Weeks |
| Percent of days abstinent from any alcohol | 12 Weeks |
| Percent of subjects abstinent from any drinking | 12 Weeks |
| Days to relapse to first heavy drinking day | 12 Weeks |
| Incidence of Adverse Events | 12 Weeks |
| Number of drinks per drinking day | 12 Weeks |
Countries
United States
Outcome results
None listed