A Clinical Trial of Acamprosate for Treatment of Methamphetamine Addiction

Methamphetamine Dependence, Treatment Seeking Clinical Trial

— AcampMet  

Official title:

A Placebo-controlled, Double Blind, Randomized Trial of Acamprosate for the Treatment of Methamphetamine Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00571922
• Other study ID #: 06-632
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 10, 2007
• Last updated: March 23, 2017
• Start date: July 2007
• Est. completion date: November 2008

Study information

• Verified date: March 2017
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This clinical trial will compare 10 week treatment with acamprosate (2 gr/day) versus placebo, combined with weekly abstinence oriented individual counseling, in methamphetamine dependent patients, 72 subjects will be enrolled, with an interim analysis scheduled after 36 enrolled. Primary outcome is methamphetamine absitience over the 10 week treatment period, and the last 2 weeks of treatment. Abstinence is defined on a weekly basis as no urine positive of methamphetamine (or amphetamine) and self-report of not use for the 7 day period. Secondary measures include treatment retention, drug craving, mood, and safety.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Methamphetamine dependence

• Treatment seeking

• Urine sample (+) for methamphetamine

Exclusion Criteria:

• Pregnancy

• Dependence on other drugs (except nicotine)

• DSM-IV axis I disorder unrelated to drug abuse

• Serious medical condition in clinicians opinion.

• AIDs

• Untreated syphilis

• Allergy to acamprosate

• Methadone, or other ORP, maintenance

Related Conditions & MeSH terms

• Methamphetamine Dependence, Treatment Seeking

Intervention

Drug:
• Acamprosate
2 gr/day (333 mg, TID)
• placebo
matching placebo

Locations

Country	Name	City	State
United States	VA New York Harbor Healthcare System, MHAD clinic	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York University School of Medicine	Forest Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Methamphetamine Abstinence		7 day
Secondary	Craving		7 day