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

Sponsor

National Institute on Drug Abuse (NIDA) (NIH)

Overall Status

Terminated

CT.gov ID

NCT00218049

Collaborator

University of Texas (Other)

Enrollment

Location

Arms

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cocaine Abuse Cocaine-Related Disorders	Drug: GBR 12909 Drug: GBR 12909 Drug: GBR 12909	Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

3 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Dec 1, 2004

Actual Primary Completion Date :

Jul 1, 2005

Actual Study Completion Date :

Jul 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 50 mg of GBR 12909	Drug: GBR 12909 50mg GBR 12909 over 12 days
Experimental: 2 75 mg of GBR 12909	Drug: GBR 12909 GBR 12909 75 mg over 12 day period
Experimental: 3 100 mg of GBR 12909	Drug: GBR 12909 GBR 12909 100 mg over 12 day period

Arm

Intervention/Treatment

Experimental: 1

50 mg of GBR 12909

Drug: GBR 12909

50mg GBR 12909 over 12 days

Experimental: 2

75 mg of GBR 12909

Drug: GBR 12909

GBR 12909 75 mg over 12 day period

Experimental: 3

100 mg of GBR 12909

Drug: GBR 12909

GBR 12909 100 mg over 12 day period

Outcome Measures

Primary Outcome Measures

Medication effects, including frequency of adverse events [12 days of trial]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Texas Health Science Center	Houston	Texas	United States	77030

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)
University of Texas

Investigators

Principal Investigator: John Grabowski, PhD, University of Texas

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00218049

Other Study ID Numbers:

NIDA-09262-10
P50-09262-10
DPMC

First Posted:

Sep 22, 2005

Last Update Posted:

Jan 12, 2017

Last Verified:

Aug 1, 2008

Additional relevant MeSH terms:

Cocaine-Related Disorders

Vanoxerine

Study Results

No Results Posted as of Jan 12, 2017