A Clinical Trial of Acamprosate for Treatment of Methamphetamine Addiction (AcampMet)

March 23, 2017 updated by: NYU Langone Health

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10010
        • VA New York Harbor Healthcare System, MHAD clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: placebo
matching placebo
Active Comparator: Acamprosate
Drug: Acamprosate
2 gr/day (333 mg, TID)
Other Names:
  • Campral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Methamphetamine Abstinence
Time Frame: 7 day
7 day

Secondary Outcome Measures

Outcome Measure
Time Frame
Craving
Time Frame: 7 day
7 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Collaborators

Forest Laboratories

Investigators

  • Principal Investigator: Malcolm Reid, PhD, NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

December 10, 2007

First Submitted That Met QC Criteria

December 11, 2007

First Posted (Estimate)

December 12, 2007

Study Record Updates

Last Update Posted (Actual)

March 24, 2017

Last Update Submitted That Met QC Criteria

March 23, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-632

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Methamphetamine Dependence, Treatment Seeking

Clinical Trials on placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belgium

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe