Study of Adderall-XR for the Treatment of Adult Attention Deficit Hyperactivity Disorder and Cocaine Dependence

Launched by NEW YORK STATE PSYCHIATRIC INSTITUTE · Nov 2, 2007

Keywords

ClinConnect Summary

Specific Aim 1: To determine the efficacy of ER-MAS in promoting cocaine abstinence and ADHD improvement among comorbid ADHD and cocaine-dependent patients.

Primary Hypothesis: benzoylecgonine positive urine screens will decrease with greatest to least reductions from 80mg\>60mg\>PBO (placebo).

Hypothesis 2: ADHD-Rating Scale will decrease with greatest to least reductions from 80mg\>60mg\>PBO.

Specific Aim 2: To determine the effect of ER-MAS on improving general functioning and impulsivity among comorbid ADHD and cocaine-dependent patients.

Hypothesis 4: There will be greater improved...

Gender

ALL

Eligibility 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 four 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. Individuals must be capable of giving informed consent and capable of complying with study procedures.
• • 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.
• Exclusion Criteria:
• • 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 study period.
• • 3. Individuals with current major depressive disorder.However,individuals who are currently stable on a psychotropic medication for three months with a HAM-D \<14 may be included.
• • 4. Individuals physiologically dependent on any other drugs (excluding nicotine or cannabis) 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. Individuals who are legally mandated (e.g., to avoid incarceration, monetary or other penalties, etc.) to participate in substance abuse treatment program
• • 13. History of glaucoma
• • 14. Individuals who report use of MAOI within 14 days of study start