Topiramate for the Treatment of Methamphetamine Dependence - 1

National Institutes of Health (NIH)

Status and phase: Completed; Phase 2

Conditions: Methamphetamine

Treatments: Drug: Topiramate; Drug: Placebo Oral Tablet

Study type: Interventional

Funder types: NIH

Identifiers

NCT00345371

NIDA-CSP-1025-1

Details and patient eligibility

About

The purpose of this study is to assess the efficacy and safety of topiramate as compared to placebo in reducing methamphetamine use in subjects with methamphetamine dependence.

Enrollment: 140 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Treatment seeking individuals as the time of the study
• Must be able to proved written informed consent
• Must have a body mass index greater than 18 kg/m(2)
• Must meet DSM-IV criteria for methamphetamine dependence
• Must currently be using methamphetamine as confirmed by a positive urine test over the past 14 days
• If female of child bearing potential, must agree to use birth control

Exclusion criteria

• Please contact the site for more information

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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140 participants in 2 patient groups, including a placebo group

Topiramate

Active Comparator group

Description:

Subjects will receive topiramate (in tablet form) up to 200 mg/day for 13 weeks.

Treatment:

Drug: Topiramate

Placebo Oral Tablet

Placebo Comparator group

Description:

After randomization subjects will receive topiramate matched placebo (in tablet form), up to 200 mg/day for 13 weeks.

Treatment:

Drug: Placebo Oral Tablet