ALK21-003: Study of Medisorb® Naltrexone (VIVITROL®) in Alcohol-Dependent Adults

PHASE3CompletedINTERVENTIONAL
Enrollment

624

Participants

Timeline

Start Date

February 28, 2002

Primary Completion Date

September 30, 2003

Study Completion Date

September 30, 2003

Conditions
Alcoholism
Interventions
DRUG

Medisorb naltrexone 190 mg

Intramuscular (IM) injection once every 4 weeks for a total of 6 administrations.

DRUG

Medisorb naltrexone 380 mg

IM injection once every 4 weeks for a total of 6 administrations.

DRUG

Placebo matching Medisorb naltrexone 190 mg

IM injection once every 4 weeks for a total of 6 administrations.

DRUG

Placebo matching Medisorb naltrexone 380 mg

IM injection once every 4 weeks for a total of 6 administrations.

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Alkermes, Inc.

INDUSTRY