Assessment of GVG for the Treatment of Methamphetamine Dependence

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. Identifier: NCT00506935
Recruitment Status : Completed
First Posted : July 25, 2007
Last Update Posted : July 13, 2017
University of California, Los Angeles
Information provided by (Responsible Party):
Thomas Newton, Baylor College of Medicine

Brief Summary:
The purpose of this study is to find out if GVG can reduce drug use and determine safety and effects of GVG when used together with methamphetamine. This study involves staying in the hospital for 21 days. Participants will receive either placebo or GVG, and a limited amount if methamphetamine will be injected on some study days. This study will enroll people that use methamphetamine. Participants will be compensated.

Condition or disease Intervention/treatment Phase
Methamphetamine Addiction Drug: GVG Drug: placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Phase 1 Study of Vigabatrin (GVG) for Methamphetamine Dependence
Study Start Date : July 2006
Actual Primary Completion Date : April 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Methamphetamine
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
Drug: GVG
5 grams GVG
Other Name: vigabatrin
Placebo Comparator: 2
Drug: placebo

Information from the National Library of Medicine

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 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Be English-speaking volunteers who are not seeking treatment at the time of the study;
  2. Be between 18-55 years of age;
  3. Meet DSM-IV TR criteria for MA abuse or dependence;
  4. Have a self-reported history of using MA by the smoked or IV route, for at least 2 years.
  5. Have vital signs as follows: resting pulse between 50 and 90 bpm, blood pressures between 85-150mm Hg systolic and 45-90mm Hg diastolic; this criterion must be met within 2 days of admission.
  6. Have hematology and chemistry laboratory tests that are within normal (+/- 10%) limits with the following exceptions: a) liver function tests (total bilirubin, ALT, AST, and alkaline phosphatase) < 3 x the upper limit of normal, and b) kidney function tests (creatinine and BUN) < 2 x the upper limit of normal;
  7. Have a baseline ECG that demonstrates normal sinus rhythm, normal conduction, and no clinically significant arrhythmias;
  8. Be able to fully cooperate with visual field testing to the point that a valid test is obtained during screening/baseline.
  9. In the judgment of the study ophthalmologist, have visual fields within normal limits for age during the screening/baseline measurements;
  10. Have acceptable ERG results for initiation of treatment with GVG (in the judgment of Drs. Nusinowitz and Newton, with ophthalmologic consultation as needed) , including having a value of the 30 Hz Flicker a-b amplitude as measured during the screening/baseline electroretinogram evaluations of 52 μV or above;
  11. Have a medical history and brief physical examination demonstrating no clinically significant contraindications for study participation, in the judgment of the admitting physician and the principal investigator.

Exclusion Criteria:

  1. Have any history or evidence suggestive of seizure disorder or brain injury;
  2. Have any previous medically adverse reaction to MA, including loss of consciousness, chest pain, or epileptic seizure;
  3. Have neurological or psychiatric disorders, such as:

    • psychosis, bipolar illness or major depression as assessed by the MINI;
    • organic brain disease or dementia assessed by clinical interview;
    • history of any psychiatric disorder which would require ongoing treatment or which would make study compliance difficult;
    • history of suicide attempts within the past three months assessed by the MINI and/or current suicidal ideation/plan as assessed by the MINI;
  4. Have evidence of clinically significant heart disease or hypertension, as determined by the PI;
  5. Have a family history in first-degree relatives of early cardiovascular morbidity or mortality, as determined by the PI;
  6. Have any ophthalmologic disorder (e.g., glaucoma, cataracts, optic nerve disease, fixation problems, etc.) which, in the judgment of the study ophthalmologist, would:

    • make it difficult to obtain valid ophthalmologic perimetry, or electroretinography (ERG) assessments, or
    • increase the risks of visual side effects associated with VGB.
  7. Have evidence of untreated or unstable medical illness including: neuroendocrine, autoimmune, renal, hepatic, or active infectious disease;
  8. Have HIV and are currently symptomatic, have a diagnosis of AIDS, or are receiving antiretroviral medication;
  9. Be pregnant or nursing. Other females must either be unable to conceive (i.e., surgically sterilized, sterile, or post-menopausal) or be using a reliable form of contraception (e.g., abstinence, birth control pills, intrauterine device, condoms, or spermicide). All females must provide negative pregnancy urine tests before study entry, upon hospital admission, and at the end of study participation;
  10. Have any history of asthma, chronic coughing and wheezing, or other respiratory illnesses;
  11. Currently use alpha or beta agonists, theophylline, or other sympathomimetics;
  12. Have any other illness, condition, or use of medications, which in the opinion of the PI and/or the admitting physician would preclude safe and/or successful completion of the study.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00506935

United States, California
Los Angeles, California, United States, 90024
Sponsors and Collaborators
Baylor College of Medicine
University of California, Los Angeles

Responsible Party: Thomas Newton, Professor, Baylor College of Medicine Identifier: NCT00506935     History of Changes
Other Study ID Numbers: #05-10-091-01
First Posted: July 25, 2007    Key Record Dates
Last Update Posted: July 13, 2017
Last Verified: July 2017

Keywords provided by Thomas Newton, Baylor College of Medicine:

Additional relevant MeSH terms:
Central Nervous System Stimulants
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Uptake Inhibitors
Enzyme Inhibitors
GABA Agents