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

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ClinicalTrials.gov Identifier: NCT00571922
Recruitment Status : Completed
First Posted : December 12, 2007
Results First Posted : April 6, 2016
Last Update Posted : March 24, 2017
Sponsor:
Collaborator:
Forest Laboratories
Information provided by (Responsible Party):
New York University School of Medicine

Brief 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.

Condition or disease Intervention/treatment Phase
Methamphetamine Dependence, Treatment Seeking Drug: Acamprosate Drug: placebo Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Placebo-controlled, Double Blind, Randomized Trial of Acamprosate for the Treatment of Methamphetamine Dependence
Study Start Date : July 2007
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Methamphetamine
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Acamprosate Drug: Acamprosate
2 gr/day (333 mg, TID)
Other Name: Campral
Placebo Comparator: Placebo Drug: placebo
matching placebo



Primary Outcome Measures :
  1. Methamphetamine Abstinence [ Time Frame: 7 day ]

Secondary Outcome Measures :
  1. Craving [ Time Frame: 7 day ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00571922     History of Changes
Other Study ID Numbers: 06-632
First Posted: December 12, 2007    Key Record Dates
Results First Posted: April 6, 2016
Last Update Posted: March 24, 2017
Last Verified: March 2017

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