A Clinical Trial of Acamprosate for Treatment of Methamphetamine Addiction
AcampMet
A Placebo-controlled, Double Blind, Randomized Trial of Acamprosate for the Treatment of Methamphetamine Dependence
1 other identifier
interventional
72
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 10, 2007
CompletedFirst Posted
Study publicly available on registry
December 12, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2008
CompletedResults Posted
Study results publicly available
April 6, 2016
CompletedMarch 24, 2017
March 1, 2017
1.3 years
December 10, 2007
February 5, 2016
March 23, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Methamphetamine Abstinence
7 day
Secondary Outcomes (1)
Craving
7 day
Study Arms (2)
Acamprosate
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Methamphetamine dependence
- Treatment seeking
- Urine sample (+) for methamphetamine
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NYU Langone Healthlead
- Forest Laboratoriescollaborator
Study Sites (1)
VA New York Harbor Healthcare System, MHAD clinic
New York, New York, 10010, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Sadly, the PI of this study passed away on 4/20/2010. Data was not analyzed and is unavailable.
Results Point of Contact
- Title
- The Office of Clinical Trials
- Organization
- NYU Langone Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Malcolm Reid, PhD
NYU Langone Health
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 10, 2007
First Posted
December 12, 2007
Study Start
July 1, 2007
Primary Completion
November 1, 2008
Study Completion
November 1, 2008
Last Updated
March 24, 2017
Results First Posted
April 6, 2016
Record last verified: 2017-03