Long-Term Safety Study of Naltrexone Long Acting Injection in Alcohol or Opiate Dependent Adults. - Full Text View

Sponsored by:	Alkermes
Information provided by:	Alkermes
ClinicalTrials.gov Identifier:	NCT00156936

Purpose

This is a multi-center extension of Alkermes study ALK21-006 to further assess the long-term safety of repeat monthly doses of naltrexone long acting injection.

Condition	Intervention	Phase
Alcoholism Opiate Dependence	Drug: Naltrexone long acting injection	Phase III

MedlinePlus related topics: Alcoholism

Drug Information available for: Naltrexone Naltrexone hydrochloride Ethanol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	An Open-Label Multi-Center Study to Evaluate the Long-Term Safety of Naltrexone Long Acting Injection (Extension of Study ALK21-006)

Further study details as provided by Alkermes:

Primary Outcome Measures:

Long-term safety

Secondary Outcome Measures:

Measures related to social functioning and healthcare utilization and drinking behavior

Enrollment:	108
Study Start Date:	August 2004
Study Completion Date:	January 2007
Primary Completion Date:	January 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Medisorb Naltrexone 380mg	Drug: Naltrexone long acting injection IM monthly injection

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Has satisfactorily completed study ALK21-006 or other qualifying naltrexone long acting injection clinical trial
Is willing and able to return for scheduled clinic visits and study assessments
Has a stable address
If female and of childbearing potential, must agree to use an approved method of contraception for the duration of the study and for 1 month following the last dose
Provides written informed consent for this study

Exclusion Criteria:

Is pregnant or currently breastfeeding
Terminated early from study drug in a previous naltrexone long acting injection clinical trial
Has any finding that in the view of the Principal Investigator would compromise the subject's ability to fulfill the protocol visit schedule and/or visit requirements

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00156936

Locations

United States, Massachusetts
Alkermes Clinical Development
Cambridge, Massachusetts, United States, 02139

Sponsors and Collaborators

Alkermes

More Information

Study ID Numbers:	ALK21-006EXT
Study First Received:	September 7, 2005
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00156936
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Mental Disorders
Naltrexone
Alcoholism
Substance-Related Disorders

Disorders of Environmental Origin
Alcohol-Related Disorders
Opioid-Related Disorders
Ethanol

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Narcotic Antagonists

Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009