Phase 2 N=81 Randomized Triple-blind Treatment

A Placebo-Controlled Study of Mixed Amphetamine Salts and Topiramate for the Treatment of Cocaine Dependence

Cocaine Dependence

Bottom Line

View on ClinicalTrials.gov: NCT00421603 ↗

Enrolled (actual)

Serious AEs

2.5%

Results posted

Feb 2013

Primary outcome: Primary: Three Weeks of Continuous Cocaine Abstinence as Measured by Urine Toxicology and Self Report Based on Time Line Follow Back — 13; 7 participants — p==.05

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Adderall-XR and Topiramate (Drug); Placebo (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: New York State Psychiatric Institute
Primary completion: May 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Three Weeks of Continuous Cocaine Abstinence as Measured by Urine Toxicology and Self Report Based on Time Line Follow Back	13; 7	=.05

Summary

The proposed protocol is a double-blind, placebo-controlled outpatient study of the safety and efficacy of Adderall-XR (ER-MAS) and topiramate in the treatment of cocaine dependence. Since both of these medications have independently shown promise in helping with cocaine abuse we are proposing that together they may be even more successful in the treatment of cocaine abuse. We plan to enroll 120 subjects in a 14-week trial. The primary objective of the study is to determine the efficacy of ER-MAS and topiramate in promoting cocaine abstinence among cocaine-dependent patients. This study includes free treatment for cocaine dependence that includes medication.

Eligibility Criteria

Inclusion Criteria

Men and women between the ages of 18-60 who meet DSM-IV criteria for current cocaine dependence (DSM-IV-TR).
Used cocaine at least four days in the past month, with at least weekly cocaine use.
Must have a Body Mass Index (BMI) > 18 kg/m2
Alcohol Breathalyzer (BraC) at consent of 150, DBP> 90, or HR > 100 when sitting quietly), acute hepatitis (patients with chronic mildly elevated transaminases < 3x upper limit of normal are acceptable), or uncontrolled diabetes.
Individuals with a history of seizures
History of allergic reaction to candidate medication (amphetamine and/or ER-MAS or topiramate).
Women who are pregnant or nursing.
Use of carbonic anhydrase inhibitors*
History of glaucoma, kidney stones*
History of failure to respond to a previous Adequate trial of either candidate medication for Cocaine dependence
Currently being prescribed psychotropic medication by another physician (other than sleep medication)
Individuals who are legally mandated (e.g., to avoid incarceration, monetary or other penalties, etc.) to participate in substance abuse treatment program -

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Data sourced from ClinicalTrials.gov (NCT00421603). 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.