Interaction Between Vanoxerine (GBR 12909) and Cocaine in Cocaine Dependent Individuals

Cocaine is a strong central nervous system stimulant that is widely abused throughout the
United Sates. Due to its widespread use, it is important to develop an effective treatment
for cocaine dependence. Dopamine transporters (DAT) play an important role in the addictive
nature of cocaine; the use of compounds that target DAT may be effective in treating cocaine
dependent individuals. Research shows that GBR 12909 has a strong affinity for DAT. The
purpose of this study is to determine the safety and potential interaction of GBR 12909 and
cocaine in cocaine dependent individuals.

Inclusion Criteria:

- Meets DSM-IV criteria for current cocaine dependence

- Not currently seeking treatment for cocaine dependence

- Currently uses cocaine, as determined by a self-report and a positive urine test for
cocaine, within 30 days prior to study entry

- Within 20 % of ideal body weight, and weighs at least 100 lbs

- Good general health

- Normal electrocardiogram

- Willing to use acceptable methods of contraception for the duration of the study

Exclusion Criteria:

- Current or history of a major psychiatric illness, other than drug dependence or
disorders secondary to drug abuse

- Meets DSM-IV criteria for dependence on any drugs other than cocaine, marijuana,
nicotine, or alcohol

- Physiologically dependent on alcohol and requires medical detoxification

- Use of prescription drugs within 14 days prior to study entry

- Use of non-prescription drugs within 7 days prior to study entry

- If female, used an oral contraceptive, Depo-Provera, Norplant, or intrauterine
progesterone contraceptive system, within 30 days prior to study entry

- Pregnant or breastfeeding

- History of liver disease

- Current elevated aspartate aminotransferase or alanine aminotransferase levels

- Donated a unit of blood within 4 weeks prior to study entry

- Participated in any other clinical investigation within 4 weeks prior to study entry

- History of any illness or behavior that, in the opinion of the investigator, might
interfere with the study

- Family history of early significant cardiovascular disease

- Exhibits Hepatitis B surface antigen or Hepatitis C antibody

- HIV infected

- Syphilis

- Active tuberculosis

- Adult asthma

- Chronic obstructive pulmonary disease

- Unable to distinguish between 20 mg and 40 mg of intravenous cocaine