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.
||Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
|Ages Eligible for Study:||18 Years|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
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
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.
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
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) 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
13. Individuals who are legally mandated (e.g., to avoid incarceration, monetary or other
penalties, etc.) to participate in substance abuse treatment program