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A Randomized, Double-Blind, Placebo-Controlled Study of Mixed Amphetamine Salts (Adderall-XR) for the Treatment of Adult Attention Deficit Hyperactivity Disorder (ADHD) and Cocaine Dependence

This study is currently Recruiting

October 2011 By New York State Psychiatric Institute

First Recieved on November 2, 2007

Last Updated on October 13, 2011

Sponsor: New York State Psychiatric Institute
Collaborators: National Institute on Drug Abuse (NIDA)
Information provided by: New York State Psychiatric Institute
Identifier: NCT00553319

Purpose

The proposed protocol is a 3 group double-blind, placebo-controlled outpatient study of the safety and efficacy of Adderall-XR (ER-MAS) in the treatment of comorbid ADHD and cocaine dependence. Since this medication has independently shown promise in helping with ADHD and cocaine abuse, we are proposing that it may be successful in the treatment of comorbid ADHD and cocaine abuse. We plan to enroll 75 subjects in a 14-week trial. The primary objectives of the study are to determine the efficacy of ER-MAS in promoting cocaine abstinence and improvement in ADHD symptomology among cocaine-dependent patients with comorbid ADHD.

Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Eligibility

Ages Eligible for Study:18 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No
Criteria

Inclusion Criteria: 1. Men and women between the ages of 18-60 who meet DSM-IV criteria for current cocaine dependence and adult ADHD (DSM-IV-TR). 2. Used cocaine at least eleven days in the past month 3. Must have a Body Mass Index (BMI) > 18 kg/m2 4. Alcohol Breathalyzer (BraC) at consent of < 0.04% 5. Must have a positive benzoylecognine urine screen during evaluation 6. Individuals must be capable of giving informed consent and capable of complying with study procedures. 7. 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: 1. Meets DSM-IV-TR criteria for other SUD (nicotine excepted), 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 study period. 3. Individuals with current major depressive disorder. 4. Individuals physiologically dependent on any other drugs (excluding nicotine) which require medical intervention. 5. Individuals with current suicidal risk. 6. Individuals with coronary vascular disease as indicated by history or suspected by abnormal ECG, cardiac symptoms, fainting, open-heart surgery and/or arrhythmia, and family history of ventricular tachycardia/sudden death. 7. Unstable physical disorders which might make participation hazardous such as uncontrolled hypertension (SBP > 140, 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. 8. Individuals with a history of seizures 9. History of allergic reaction to candidate medication (amphetamine and/or ER-MAS). 10. Women who are pregnant or nursing. 11. History of failure to respond to a previous adequate trial of the candidate medication for cocaine dependence 12. Currently being prescribed psychotropic medication by another physician (other than sleep medication) 13. Individuals who are legally mandated (e.g., to avoid incarceration, monetary or other penalties, etc.) to participate in substance abuse treatment program

Investigators

  • Investigator: Frances R Levin, MD - Principal Investigator - Columbia University
  • Investigator: John Grabowski - Principal Investigator - University of Minnesota - Clinical and Translational Science Institute

Locations

  • Ambulatory Research Center/Fairview University Psychiatry Dept

    Minneapolis, Minnesota 55454 United States

  • STARS

    New York, New York 10032 United States

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