Phase 2 N=140 Randomized Triple-blind Treatment

Topiramate for the Treatment of Methamphetamine Dependence - 1

Methamphetamine

Bottom Line

View on ClinicalTrials.gov: NCT00345371 ↗

Enrolled (actual)

140

Serious AEs

7.9%

Results posted

Feb 2017

Primary outcome: Primary: Abstinence (Weeks 6 - 12) — 49; 49; 43; 48 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Topiramate (Drug); Placebo Oral Tablet (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: National Institute on Drug Abuse (NIDA)
Primary completion: Aug 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Abstinence (Weeks 6 - 12)	49; 49; 43; 48; 46; 45	—
SECONDARY Abstinence (Weeks 1 - 12)	58; 53; 56; 50; 55; 50	—

Summary

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.

Eligibility Criteria

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

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Data sourced from ClinicalTrials.gov (NCT00345371). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.