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

NYU Langone Health

Status and phase: Completed; Phase 2; Phase 1

Conditions: Methamphetamine Dependence, Treatment Seeking

Treatments: Drug: Acamprosate; Drug: placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00571922

06-632

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 2 patient groups, including a placebo group

Acamprosate

Active Comparator group

Treatment:

Drug: Acamprosate

Placebo

Placebo Comparator group

Treatment:

Drug: placebo