Study of Naltrexone for Methamphetamine Addiction

NCT ID: NCT00984360

Last Updated: 2013-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2012-09-30

Brief Summary

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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

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Conditions

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Methamphetamine Dependence

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A118G

Group Type EXPERIMENTAL

Naltrexone

Intervention Type DRUG

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

Wild-type

Group Type EXPERIMENTAL

Naltrexone

Intervention Type DRUG

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

Interventions

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Naltrexone

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

Intervention Type DRUG

Other Intervention Names

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Vivitrol Vivitrex

Eligibility Criteria

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Inclusion Criteria

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

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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California Pacific Medical Center Research Institute

OTHER

Sponsor Role lead

Responsible Party

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John Mendelson, MD

Senior Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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John Mendelson, MD

Role: PRINCIPAL_INVESTIGATOR

California Pacific Medical Center

Locations

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Addiction & Pharmacology Research Laboratory

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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1R01DA027161-01

Identifier Type: NIH

Identifier Source: org_study_id

View Link

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