Study of Naltrexone for Methamphetamine Addiction

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
John Mendelson, MD, California Pacific Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT00984360
First received: September 14, 2009
Last updated: May 29, 2013
Last verified: May 2013
  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 2

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:


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 ]

Enrollment: 22
Study Start Date: September 2009
Study Completion Date: September 2012
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: John Mendelson, MD, Senior Scientist, 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: May 29, 2013
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
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 July 23, 2014