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

Study Overview
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Brief Summary
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Cocaine dependence is a major public health problem; an effective primary treatment for cocaine dependent individuals has yet to be found. The purpose of this study is to determine the safety and effects of vanoxerine (GBR 12909) in treating cocaine dependent individuals.

Detailed Description
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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.

Official Title
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Phase 1, Double-blind, Placebo-controlled Assessment of Interactions Between 2 Doses of Cocaine and Three Doses of Escalating Vanoxerine (GBR 12909) in Cocaine Using Volunteers

Conditions
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Cocaine Abuse, Cocaine-Related Disorders

Intervention / Treatment
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* Drug: GBR 12909
* Drug: GBR 12909
* Drug: GBR 12909


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>50 mg of GBR 12909 | Drug: GBR 12909<br>* 50mg GBR 12909 over 12 days<br>|
| Experimental: 2<br>75 mg of GBR 12909 | Drug: GBR 12909<br>* GBR 12909 75 mg over 12 day period<br>|
| Experimental: 3<br>100 mg of GBR 12909 | Drug: GBR 12909<br>* GBR 12909 100 mg over 12 day period<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication effects, including frequency of adverse events |  | 12 days of trial |