Study of Naltrexone for Methamphetamine Addiction

This study is ongoing, but not recruiting participants.

First Received on September 14, 2009. Last Updated on June 21, 2011 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:	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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 Study Completion Date:	July 2011
Estimated Primary Completion Date:	July 2011 (Final data collection date for primary outcome measure)

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

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

Locations

United States, California
Addiction & Pharmacology Research Laboratory
San Francisco, California, United States, 94110

Sponsors and Collaborators

California Pacific Medical Center Research Institute

Investigators

Principal Investigator:

John Mendelson, MD

California Pacific Medical Center

More Information

No publications provided

Responsible Party:	E. Keith Flower, MD, California Pacific Medical Center Research Institute
ClinicalTrials.gov Identifier:	NCT00984360 History of Changes
Other Study ID Numbers:	1R01DA027161-01
Study First Received:	September 14, 2009
Last Updated:	June 21, 2011
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:

Behavior, Addictive
Compulsive Behavior
Impulsive Behavior
Naltrexone
Methamphetamine
Amphetamine
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents

Therapeutic Uses
Sympathomimetics
Autonomic Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Dopamine Uptake Inhibitors

ClinicalTrials.gov processed this record on February 09, 2012