Clinical trial NCT00345371: Topiramate for the Treatment of Methamphetamine Dependence - 1
Official title: Phase 2, Double-Blind, Placebo-Controlled Trial of Topiramate for the Treatment of Methamphetamine Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Methamphetamine
Keywords: methamphetamine addiction
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2006-06-28
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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:

* Please contact the site for more information

Primary outcomes:
measure: Abstinence (Weeks 6 - 12)
timeFrame: weeks 6 through 12
Secondary outcomes:
measure: Abstinence (Weeks 1 - 12)
timeFrame: Weeks 1 through 12
Other outcomes:
Locations:
city: Costa Mesa
country: United States
facility: Matrix Institute on Addictions
state: California
city: San Diego
country: United States
facility: South Bay Treatment Center
state: California
city: Torrance
country: United States
facility: Torrance Site
state: California
city: Honolulu
country: United States
facility: John A. Burns School of Medicine
state: Hawaii
city: Des Moines
country: United States
facility: Powell Chemical Dependency Center
state: Iowa
city: Kansas City
country: United States
facility: University of Missouri - Kansas City
state: Missouri
city: Salt Lake City
country: United States
facility: Salt Lake City VA Medical Center
state: Utah
city: Charlottesville
country: United States
facility: UVA CARE
state: Virginia
Study officials:
affiliation: VA Medical Center
name: Bankole Johnson
role: PRINCIPAL_INVESTIGATOR
References:
citation: Elkashef A, Kahn R, Yu E, Iturriaga E, Li SH, Anderson A, Chiang N, Ait-Daoud N, Weiss D, McSherry F, Serpi T, Rawson R, Hrymoc M, Weis D, McCann M, Pham T, Stock C, Dickinson R, Campbell J, Gorodetzky C, Haning W, Carlton B, Mawhinney J, Li MD, Johnson BA. Topiramate for the treatment of methamphetamine addiction: a multi-center placebo-controlled trial. Addiction. 2012 Jul;107(7):1297-306. doi: 10.1111/j.1360-0443.2011.03771.x. Epub 2012 Feb 28.
citation: Li MD, Wang J, Niu T, Ma JZ, Seneviratne C, Ait-Daoud N, Saadvandi J, Morris R, Weiss D, Campbell J, Haning W, Mawhinney DJ, Weis D, McCann M, Stock C, Kahn R, Iturriaga E, Yu E, Elkashef A, Johnson BA. Transcriptome profiling and pathway analysis of genes expressed differentially in participants with or without a positive response to topiramate treatment for methamphetamine addiction. BMC Med Genomics. 2014 Dec 12;7:65. doi: 10.1186/s12920-014-0065-x.