NCT00984360

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2009

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2009

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 25, 2009

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

May 31, 2013

Status Verified

May 1, 2013

Enrollment Period

1.8 years

First QC Date

September 14, 2009

Last Update Submit

May 29, 2013

Conditions

Methamphetamine Dependence

Keywords

MethMethamphetamine AddictionMethamphetamine TreatmentNaltrexoneVivitrolA118GOPRM1

Outcome Measures

Primary Outcomes (1)

  • MA (-) Urine Samples

    Twice weekly for 5 weeks

Study Arms (2)

A118G

EXPERIMENTAL
Drug: Naltrexone

Wild-type

EXPERIMENTAL
Drug: Naltrexone

Interventions

NaltrexoneDRUG

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

Also known as: Vivitrol, Vivitrex
A118GWild-type

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Addiction & Pharmacology Research Laboratory

San Francisco, California, 94110, United States

Location

MeSH Terms

Interventions

Naltrexonevivitrol

Intervention Hierarchy (Ancestors)

NaloxoneMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • John Mendelson, MD

    California Pacific Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientist

Study Record Dates

First Submitted

September 14, 2009

First Posted

September 25, 2009

Study Start

September 1, 2009

Primary Completion

July 1, 2011

Study Completion

September 1, 2012

Last Updated

May 31, 2013

Record last verified: 2013-05

Locations

US(1)