A Placebo-Controlled Study of Mixed Amphetamine Salts and Topiramate for the Treatment of Cocaine… (NCT00421603) | Clinical Trial Compass
CompletedPhase 2
A Placebo-Controlled Study of Mixed Amphetamine Salts and Topiramate for the Treatment of Cocaine Dependence
United States81 participantsStarted 2007-02
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexALL
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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 \< 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 criteria
✕. Meets DSM-IV-TR criteria for bipolar disorder, Schizophrenia, or any psychotic disorder other than transient psychosis due to drug abuse
What they're measuring
1
Three Weeks of Continuous Cocaine Abstinence as Measured by Urine Toxicology and Self Report Based on Time Line Follow Back
Timeframe: 3 weeks of abstinence during 14 weeks of trial or for length of participation
✕. 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.