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

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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00218049

Enrollment

Registered

2005-09-22

Start date

2004-12-31

Completion date

2005-07-31

Last updated

2017-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cocaine Abuse, Cocaine-Related Disorders

Brief summary

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

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.

Interventions

DRUGGBR 12909

50mg GBR 12909 over 12 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Medication effects, including frequency of adverse events	12 days of trial

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026