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

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00571922
First received: December 10, 2007
Last updated: March 7, 2016
Last verified: March 2016
  Purpose
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.

Condition Intervention Phase
Methamphetamine Dependence, Treatment Seeking
Drug: Acamprosate
Drug: placebo
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Placebo-controlled, Double Blind, Randomized Trial of Acamprosate for the Treatment of Methamphetamine Dependence

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Methamphetamine Abstinence [ Time Frame: 7 day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Craving [ Time Frame: 7 day ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: July 2007
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Acamprosate Drug: Acamprosate
2 gr/day (333 mg, TID)
Other Name: Campral
Placebo Comparator: Placebo Drug: placebo
matching placebo

  Eligibility

Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00571922

Locations
United States, New York
VA New York Harbor Healthcare System, MHAD clinic
New York, New York, United States, 10010
Sponsors and Collaborators
New York University School of Medicine
Forest Laboratories
Investigators
Principal Investigator: Malcolm Reid, PhD New York University School of Medicine
  More Information

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00571922     History of Changes
Other Study ID Numbers: AcamprosateMethamphetamine 
Study First Received: December 10, 2007
Results First Received: February 5, 2016
Last Updated: March 7, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by New York University School of Medicine:
methamphetamine, crystal, treatment

Additional relevant MeSH terms:
Methamphetamine
Acamprosate
Central Nervous System Stimulants
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors
Alcohol Deterrents

ClinicalTrials.gov processed this record on August 29, 2016