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

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by:
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00571922
First received: December 10, 2007
Last updated: June 3, 2011
Last verified: June 2011
History of Changes

December 10, 2007
June 3, 2011
July 2007
Not Provided
methamphetamine abstinence [ Time Frame: 7 day ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00571922 on ClinicalTrials.gov Archive Site
craving [ Time Frame: 7 day ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Clinical Trial of Acamprosate for Treatment of Methamphetamine Addiction
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 ouitcome is methamphetamine nabsitience over the 10 week treatment period, and the last 2 weeks of treatment. Abstinence is defined on a weekly basis as no urines 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.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Methamphetamine Dependence, Treatment Seeking
  • Drug: Acamprosate
    2 gr/day (333 mg, TID)
    Other Name: Campral
  • Drug: placebo
    matching placebo
    Other Name: placebo
  • Active Comparator: 1
    Acamprosate
    Intervention: Drug: Acamprosate
  • Placebo Comparator: 2
    placebo medication
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
72
Not Provided
Not Provided

Inclusion Criteria:

  • Methamphetamine dependence
  • Treatment seeking
  • Urine sample (+) for methmamphetamine

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 syphyilis
  • Allergy to acamprosate
  • Methadone, or other ORP, maintenence
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00571922
AcamprosateMethamphetamine, CMP-MD-17
No
Malcolm S. Reid, Assistant Professor, New York University School of Medicine, Department of Psychiatry
New York University School of Medicine
Forest Laboratories
Principal Investigator: Malcolm Reid, PhD New York University School of Medicine
New York University School of Medicine
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP