A Placebo-Controlled Study of Mixed Amphetamine Salts and Topiramate for the Treatment of Cocaine Dependence
Information source: New York State Psychiatric Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Cocaine Dependence
Intervention: Adderall-XR and Topiramate (Drug); Placebo (Drug)
Phase: Phase 2
Sponsored by: New York State Psychiatric Institute
Official(s) and/or principal investigator(s):
Frances R Levin, M.D., Principal Investigator, Affiliation: Columbia University
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.
Official title: A Randomized, Double-Blind, Placebo-Controlled Study of Mixed Amphetamine Salts (Adderall-XR) and Topiramate for the Treatment of Cocaine Dependence
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Three Weeks of Continuous Cocaine Abstinence as Measured by Urine Toxicology and Self Report
Pattern of Cocaine Use as Measured by the TimeLine Followback
Specific Aim 1: To determine the efficacy of ER-MAS and topiramate in promoting cocaine
abstinence among cocaine-dependent patients.
Primary Hypothesis: The proportion of participants achieving sustained cocaine abstinence
(via urine toxicology) for three consecutive weeks during the study will be significantly
greater for the combined pharmacotherapies group compared to the placebo group.
Hypothesis 2: The proportion of urine samples negative for cocaine metabolites will be
greater in the combined pharmacotherapies group compared to the placebo group.
Hypothesis 3: The pattern of cocaine use (amount of cocaine used per day in dollars and the
number of using days per week), as measured by the time-line follow-back method, will show a
greater reduction in use for the combined pharmacotherapies group compared to the placebo
Specific Aim 2: To determine the effect of ER-MAS and topiramate on cocaine craving among
Hypothesis 4: Cocaine craving symptoms will be reduced to a greater degree in the combined
pharmacotherapies group compared to the placebo group.
Specific Aim 3: To explore a set of related secondary outcomes (treatment retention, global
functioning, HIV risk behavior) as well as moderators and mediators potentially reflective
of mechanism of action.
Minimum age: 18 Years.
Maximum age: 60 Years.
1. Men and women between the ages of 18-60 who meet DSM-IV criteria for current cocaine
2. Used cocaine at least four days in the past month, with at least weekly cocaine use.
3. Must have a Body Mass Index (BMI) > 18 kg/m2
4. Alcohol Breathalyzer (BraC) at consent of < 0. 04%
5. Individuals must be capable of giving informed consent and capable of complying with
6. Women of child bearing age will be included in the study
provided that they are not pregnant, based on the results of a blood pregnancy test
drawn at the time of screening. They must also agree to use a method of
contraception with proven efficacy and agree not to become pregnant during the study.
To confirm this, blood pregnancy tests will be repeated monthly. Women will be
provided a full explanation of the potential dangers of pregnancy while on the study
medication. If a woman becomes pregnant, the study medication will be discontinued.
1. Meets DSM-IV-TR criteria for bipolar disorder, Schizophrenia, or any psychotic
disorder other than transient psychosis due to drug abuse
2. Individuals with any current Axis I psychiatric disorder as defined by DSM-IV-TR
supported by the SCID-I/P that in the investigator's judgment are unstable or would
be disrupted by study medication or are likely to require pharmacotherapy during the
3. Individuals with current major depressive disorder.
4. Individuals physiologically dependent on any other drugs (excluding nicotine or
cannabis) which require medical intervention.
5. Individuals with current psycho stimulant abuse or dependence.
6. Individuals with current suicidal risk.
7. Individuals with coronary vascular disease as indicated by history or suspected by
abnormal ECG or history of cardiac symptoms.
8. Unstable physical disorders which might make participation hazardous such as
uncontrolled hypertension (SBP > 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.
9. Individuals with a history of seizures
10. History of allergic reaction to candidate medication (amphetamine and/or ER-MAS or
11. Women who are pregnant or nursing.
12. Use of carbonic anhydrase inhibitors*
13. History of glaucoma, kidney stones*
14. History of failure to respond to a previous Adequate trial of either candidate
medication for Cocaine dependence
15. Currently being prescribed psychotropic medication by another physician (other than
16. Individuals who are legally mandated (e. g., to avoid incarceration, monetary or other
penalties, etc.) to participate in substance abuse treatment program -
Locations and Contacts
STARS, New York, New York 10032, United States
Substance Treatment and Research Service of Columbia University
Starting date: February 2007
Last updated: January 23, 2013