A Clinical Trial of Acamprosate for Treatment of Methamphetamine Addiction

NCT ID: NCT00571922

Last Updated: 2017-03-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2008-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Methamphetamine Dependence, Treatment Seeking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Acamprosate

Group Type ACTIVE_COMPARATOR

Acamprosate

Intervention Type DRUG

2 gr/day (333 mg, TID)

Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

matching placebo

Interventions

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Acamprosate

2 gr/day (333 mg, TID)

Intervention Type DRUG

placebo

matching placebo

Intervention Type DRUG

Other Intervention Names

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Campral

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Forest Laboratories

INDUSTRY

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Malcolm Reid, PhD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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VA New York Harbor Healthcare System, MHAD clinic

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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06-632

Identifier Type: -

Identifier Source: org_study_id

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