Interaction Between Vanoxerine (GBR 12909) and Cocaine in Cocaine Dependent Individuals
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00218049 |
Recruitment Status :
Terminated
(Issue of priority of resources)
First Posted : September 22, 2005
Last Update Posted : January 12, 2017
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cocaine Abuse Cocaine-Related Disorders | Drug: GBR 12909 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
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 : | December 2004 |
Actual Primary Completion Date : | July 2005 |
Actual Study Completion Date : | July 2005 |
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 |
- Medication effects, including frequency of adverse events [ Time Frame: 12 days of trial ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00218049
United States, Texas | |
University of Texas Health Science Center | |
Houston, Texas, United States, 77030 |
Principal Investigator: | John Grabowski, PhD | University of Texas |
Responsible Party: | F. Gerard Moeller, M.D., University of Texas Medical School at Houston |
ClinicalTrials.gov Identifier: | NCT00218049 |
Other Study ID Numbers: |
NIDA-09262-10 P50-09262-10 DPMC |
First Posted: | September 22, 2005 Key Record Dates |
Last Update Posted: | January 12, 2017 |
Last Verified: | August 2008 |
Cocaine-Related Disorders Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Vanoxerine Dopamine Uptake Inhibitors |
Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Dopamine Agents Neurotransmitter Agents Physiological Effects of Drugs |