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NCT00984360 Clinical Trial

Study of Naltrexone for Methamphetamine Addiction

Methamphetamine Dependence Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00984360
Other study ID # 1R01DA027161-01
Secondary ID
Status Completed
Phase Phase 2
First received September 14, 2009
Last updated May 29, 2013
Start date September 2009
Est. completion date September 2012

Study information
Verified date May 2013
Source California Pacific Medical Center Research Institute
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 22
Est. completion date September 2012
Est. primary completion date July 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

- Age between 18 and 50 years

- Patient is agreeable to conditions of study and signs consent form

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Naltrexone
380mg extended-release, given once by intramuscular gluteal injection

Locations
Country Name City State
United States Addiction & Pharmacology Research Laboratory San Francisco California

Sponsors (1)
Lead Sponsor Collaborator
California Pacific Medical Center Research Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary MA (-) Urine Samples Twice weekly for 5 weeks No
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