Status:
COMPLETED
A Placebo-Controlled Study of Mixed Amphetamine Salts and Topiramate for the Treatment of Cocaine Dependence
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Cocaine Dependence
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief 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 the...
Detailed Description
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 susta...
Eligibility Criteria
Inclusion
- 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 \< 0.04%
- Individuals must be capable of giving informed consent and capable of complying with study procedures.
- 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.
Exclusion
- Meets DSM-IV-TR criteria for bipolar disorder, Schizophrenia, or any psychotic disorder other than transient psychosis due to drug abuse
- 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 study period.
- Individuals with current major depressive disorder.
- Individuals physiologically dependent on any other drugs (excluding nicotine or cannabis) which require medical intervention.
- Individuals with current psycho stimulant abuse or dependence.
- Individuals with current suicidal risk.
- Individuals with coronary vascular disease as indicated by history or suspected by abnormal ECG or history of cardiac symptoms.
- 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.
- 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 -
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT00421603
Start Date
February 1 2007
End Date
May 1 2010
Last Update
April 24 2019
Active Locations (1)
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1
STARS
New York, New York, United States, 10032