Topiramate for Methamphetamine Dependence

Condition(s) targeted: Methamphetamine Dependence

Intervention: Topiramate (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Department of Veterans Affairs

This study seeks to evaluate the safety and the efficacy of the drug, topiramate, for the treatment of metamphetamine dependence.

This is a double-blind, placebo-controlled, randomized clinical trial. One hundred forty (140) males and females seeking treatment for methamphetamine dependence will be randomly assigned (based on site & methamphetamine use status) to one of two treatment conditions. Half of all participants will receive topiramate and half will receive a matched placebo for 91 days.

Analyses will be done after treatment to evaluate the efficacy of topiramate versus placebo for the treatment of methamphetamine dependence. The primary outcome measure is the weekly proportion of methamphetamine-free urine samples throughout treatment. Other measures of success will include: 1) the proportion of participants with 21 consecutive days of abstinence; 2) the proportion of self-reported methamphetamine non-use days; 3) the largest number of consecutive methamphetamine non-use days; and 4) reductions in use as compared to baseline.

Official title: CSP #1025 - Phase 2, Double-Blind, Placebo-Controlled Trial of Topiramate for the Treatment of Methamphetamine Dependence

Study design: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Detailed description: Addiction to methamphetamine is a growing public health concern. Currently, there are no medications approved for treating methamphetamine dependence. This study seeks to evaluate the safety and the efficacy of the drug, topiramate, for the treatment of metamphetamine dependence. Topiramate is a drug that has been approved for treating seizure disorder and preventing migraine headaches. In previous research, it has been found to be an effective treatment for alcohol and cocaine dependence.

This is a double-blind, placebo-controlled, randomized clinical trial. One hundred forty (140) males and females seeking treatment for methamphetamine dependence will participate in this study. Participants will be randomly assigned to one of two treatment conditions. Randomization will be based on clinical site and frequency of methamphetamine use (high vs. low). Half of all participants will receive the drug, topiramate, orally and half will receive a matched placebo. Treatment with either topiramate or placebo will last 91 days.

At screening and throughout treatment, routine medical and psychiatric assessments will be performed to evaluate the appropriateness and safety of all participants. These assessments will include: a structured clinical interview for DSM-IV Axis I disorders (SCID); Montgomery-Asberg Depression Rating Scale (MADRS); physical examination, vital signs & weight; a 12-lead electrocardiogram (ECG); blood chemistry & hematology; medical urinalysis, electrolytes, urine drug screen & pregnancy test (if female); a tuberculin skin test (PPD) or chest X-ray; prior & concomitant medications and adverse events.

Analyses will be done after treatment to evaluate the efficacy of topiramate versus placebo for the treatment of methamphetamine dependence. The primary outcome measure will be the weekly proportion of methamphetamine-free urine samples throughout treatment. Other measures of success will include: 1) the proportion of participants with 21 consecutive days of self-reported abstinence and methamphetamine-negative urine samples; 2) the proportion of self-reported methamphetamine non-use days; 3) the largest number of consecutive methamphetamine non-use days; and 4) reductions in use as compared to baseline.

Additional measures of treatment effect will include treatment retention, Addiction Severity Index (ASI)-Lite scores, Brief Substance Craving Scale (BSCS) scores, and Clinical Global Impression scores as assessed by the subjects (CGI-S) and an observer (CGI-O).

Minimum age: 18 Years. Gender(s): Both.

Criteria:

ELIGIBLE PARTICIPANTS MUST:

* Be at least 18 years-of-age.

* Have a diagnosis of current methamphetamine dependence.

* Be seeking treatment for methamphetamine dependence.

* Be able to provide written informed consent.

* Be willing and able to comply with study procedures.

* Have a Body Mass Index(BMI)greater than 18 kg/m2.

* Have a positive urine test for methamphetamine at screening.

* Have a negative urine pregnancy test (if female) at screening.

* Agree to use an approved method of birth control or be surgically sterile (if female).

PARTICIPANTS WILL BE EXCLUDED IF THEY:

* Have current dependence on any drug(s) other than methamphetamine, nicotine, or marijuana.

* Have dependence on alcohol or other sedatives that requires medical detoxification.

* Are clinically depressed and/or are suicidal.

* Test positive for benzodiazepines 7 days prior to treatment, or barbiturates or tricyclics 14 days prior top treatment.

* Have a psychiatric disorder(s) that requires ongoing medication and/or makes medication compliance difficult.

* Have had electroconvulsive therapy (ECT) within 90 days of enrollment.

* Have a history of Bipolar I Disorder.

* Have a current or past history of anorexia or bulimia.

* Have serious medical illnesses or neurological disorders that may compromise safety or study conduct.

* Have a history of kidney stones, kidney disease and/or impaired kidney function.

* Have diabetes with unstable blood glucose and an incidence of hypoglycemia in the year before enrollment.

* Have glaucoma.

* Are not expected to complete the study due to probable incarceration or relocation from the clinic area.

* Have AIDS, or abnormal T-lymphocyte (T-cell) blood counts.

* Are pregnant or lactating (if female).

* Have laboratory values outside of normal limits.

* Have participated in any study within 2 months prior to enrollment.

* Are suspected to have adult obstructive airway disease, or have asthma, COPD, or active tuberculosis.

* Have taken any drug with potential for damage to organs within 30 days prior to enrollment.

* Are receiving medication treatment for HIV.

* Are currently taking topiramate or any other medications that could interact adversely with topiramate.

* Are required to submit results of urine toxicology tests for court-mandated methamphetamine dependence treatment.

* Have experienced any side effects or reactions to previous treatment with topiramate.

UCLA Integrated Substance Abuse Program - Torrance, Torrance, California 90502, United States; Recruiting
Richard Rawson, Ph.D., Phone: 310-445-0874, Ext: 311, Email: rrawson@mednet.ucla.edu

South Bay Treatment Center, San Diego, California 92115, United States; Recruiting
Joseph Mawhinney, M.D., Phone: 858-581-5776, Email: jmawhin1@san.rr.com

Matrix Institute on Addictions, Costa Mesa, California 92627, United States; Recruiting
Michael McCann, M.A., Phone: 310-207-4322, Email: mickex@aol.com

John A. Burns School of Medicine, Honolulu, Hawaii 96813, United States; Recruiting
William F. Haning, M.D., Phone: 808-692-0877, Email: haning@hawaii.edu

Lutheran Hospital, Des Moines, Iowa 50309, United States; Recruiting
Dennis Weis, M.D., Phone: 515-263-2401, Email: WEISDA@ihs.org

University of Missouri - Kansas City, Dept. of Psychiatry, Kansas City, Missouri 64112, United States; Recruiting
Jan Campbell, M.D., Phone: 816-444-5455, Email: jcampbell@kc.rr.com

Salt Lake City VAMC, Salt Lake City, Utah 84148, United States; Recruiting
Christopher Stock, Pharm.D., Phone: 801- 582-1565 ext 1172, Ext: 1172, Email: christopher.stock@med.va.gov

University of Virginia Health System, Charlottesville, Virginia 22911, United States; Recruiting
Nassima Ait-Daoud Tiouririne, M.D., Phone: 434-243-0570, Email: NAT7B@hscmail.mcc.virginia.edu

Starting date: August 2006
Last updated: February 5, 2007