Study of Naltrexone for Methamphetamine Addiction

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by:

California Pacific Medical Center Research Institute

ClinicalTrials.gov Identifier:

NCT00984360

First received: September 14, 2009

Last updated: June 21, 2011

Last verified: June 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

September 14, 2009

Last Updated Date

June 21, 2011

Start Date ^ICMJE

September 2009

Estimated Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00984360 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study of Naltrexone for Methamphetamine Addiction

Official Title ^ICMJE

A Pilot Trial of Naltrexone for Methamphetamine Addiction - Role of the A118G SNP

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Methamphetamine Dependence

Intervention ^ICMJE

Drug: Naltrexone

380mg extended-release, given once by intramuscular gluteal injection

Other Names:

Vivitrol
Vivitrex

Study Arm (s)

Experimental: A118G
Intervention: Drug: Naltrexone
Experimental: Wild-type
Intervention: Drug: Naltrexone

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2011

Estimated Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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

Gender

Both

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00984360

Other Study ID Numbers ^ICMJE

1R01DA027161-01

Has Data Monitoring Committee

Yes

Responsible Party

E. Keith Flower, MD, California Pacific Medical Center Research Institute

Study Sponsor ^ICMJE

California Pacific Medical Center Research Institute

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

John Mendelson, MD

California Pacific Medical Center

Information Provided By

California Pacific Medical Center Research Institute

Verification Date

June 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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