NCT00156936View on ClinicalTrials.gov

ALK21-006EXT: Long-term Safety of Medisorb® Naltrexone (VIVITROL®) in Alcohol- or Opioid-dependent Adults (Extension of Study ALK21-006 [NCT01218997])

PHASE3TerminatedINTERVENTIONAL
Enrollment

108

Participants

Timeline

Start Date

August 31, 2004

Primary Completion Date

January 31, 2007

Study Completion Date

January 31, 2007

Conditions
AlcoholismOpiate Dependence
Interventions
DRUG

Medisorb naltrexone 380 mg

Administered via intramuscular (IM) injection once every 4 weeks. Subjects in this dosing group also received this treatment throughout the base study.

DRUG

Oral naltrexone to Medisorb naltrexone 380 mg

Subjects in this dosing group received oral naltrexone 50 mg in the base study, but received only Medisorb naltrexone 380 mg in this extension study, administered via IM injection once every 4 weeks.

Sponsors

Lead Sponsor

Alkermes, Inc.
All Listed Sponsors
lead

Alkermes, Inc.

INDUSTRY