Study of Naltrexone for Methamphetamine Addiction

This study is currently recruiting participants.

Verified by California Pacific Medical Center Research Institute, September 2009

First Received: September 14, 2009 Last Updated: September 24, 2009 History of Changes

Sponsor:	California Pacific Medical Center Research Institute
Information provided by:	California Pacific Medical Center Research Institute
ClinicalTrials.gov Identifier:	NCT00984360

Purpose

The purpose of this study is to determine whether methamphetamine-dependent individuals will use less methamphetamine when treated with naltrexone. The study will also investigate whether individuals with the mu opioid receptor gene variant A118G will use less methamphetamine than individuals without A118G.

Condition	Intervention	Phase
Methamphetamine Dependence	Drug: Naltrexone	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Official Title:	A Pilot Trial of Naltrexone for Methamphetamine Addiction - Role of the A118G SNP

Resource links provided by NLM:

MedlinePlus related topics: Methamphetamine

Drug Information available for: Methamphetamine hydrochloride Naltrexone Naltrexone hydrochloride Amphetamine Methamphetamine

U.S. FDA Resources

Further study details as provided by California Pacific Medical Center Research Institute:

Primary Outcome Measures:

MA (-) Urine Samples [ Time Frame: Twice weekly for 5 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	September 2009
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A118G: Experimental	Drug: Naltrexone 380mg extended-release, given once by intramuscular gluteal injection
Wild-type: Experimental	Drug: Naltrexone 380mg extended-release, given once by intramuscular gluteal injection

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age between 18 and 50 years
Patient is agreeable to conditions of study and signs consent form

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00984360

Contacts

Contact: Jayme Mulkey

415-641-3370

MulkeyJ@cpmcri.org

Locations

United States, California
Addiction & Pharmacology Research Laboratory	Recruiting
San Francisco, California, United States, 94110
Contact: Jayme Mulkey 415-641-3370 MulkeyJ@cpmcri.org
Principal Investigator: E. Keith Flower, MD

Sponsors and Collaborators

California Pacific Medical Center Research Institute

Investigators

Principal Investigator:

E. Keith Flower, MD

California Pacific Medical Center

More Information

No publications provided

Responsible Party:	California Pacific Medical Center Research Institute ( E. Keith Flower, MD )
Study ID Numbers:	1R01DA027161-01
Study First Received:	September 14, 2009
Last Updated:	September 24, 2009
ClinicalTrials.gov Identifier:	NCT00984360 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by California Pacific Medical Center Research Institute:

Meth
Methamphetamine Addiction
Methamphetamine Treatment
Naltrexone

Vivitrol
A118G
OPRM1

Additional relevant MeSH terms:

Amphetamine
Methamphetamine
Naltrexone
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Sympathomimetics

Narcotic Antagonists
Physiological Effects of Drugs
Central Nervous System Stimulants
Pharmacologic Actions
Sensory System Agents
Autonomic Agents
Therapeutic Uses
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010