Pilot Study of Lisdexamfetamine for Treatment of Cocaine Dependence

Evaluate ideal dose or lisdexamfetamine and tolerability, plus reduction in cocaine use and
craving as determined by self-report and cocaine-positive urine samples.

.Inclusion Criteria:

1. Men and women between the ages of 18-65 who meet DSM-IV criteria for current cocaine
dependence

2. Used cocaine at least four days in the past month

3. Individuals must be in good general health

4. Individuals must be capable of giving informed consent and capable of complying with
study procedures

5. Women of child-bearing age must agree to use a method of contraception with proven
efficacy, consisting of one of the following: 1) Any form of hormonal contraception;
2) Intra-uterine device; 3) Sterilization; 4) Double-barrier contraception which is a
combination of two of the following: condoms, spermicide, diaphragm. Pregnancy tests
will be performed monthly and if a woman becomes pregnant, the study medication will
be discontinued.

Exclusion Criteria:

1. Individuals who meet DSM-IV-TR criteria for bipolar disorder, schizophrenia, or any
psychotic disorder other than transient psychosis due to drug abuse

2. Individuals with any other current Axis I psychiatric disorder as defined by
DSM-IV-TR 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 physiologically dependent on any other drugs (excluding nicotine or
cannabis) which require medical intervention

4. Individuals with current psychostimulant abuse or dependence (other than cocaine
dependence)

5. Individuals with current suicidal risk

6. Individuals with coronary vascular disease as indicated by history or suspected by
abnormal ECG or history of cardiac symptoms

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, hyperthyroidism and/or glaucoma

9. History of allergic reaction to study medication

10. Women who are pregnant or nursing

11. Currently being prescribed psychotropic medication by another physician (other than
sleep medication)

12. Individuals who are legally mandated (e.g., to avoid incarceration) to participate in
substance abuse treatment program