Assessment of GVG for the Treatment of Methamphetamine Dependence (NCT00506935) | Clinical Trial Compass
CompletedPhase 1
Assessment of GVG for the Treatment of Methamphetamine Dependence
United States17 participantsStarted 2006-07
Plain-language 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.
Who can participate
Age range18 Years ā 55 Years
SexALL
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Inclusion criteria
ā. Be English-speaking volunteers who are not seeking treatment at the time of the study;
ā. Be between 18-55 years of age;
ā. Meet DSM-IV TR criteria for MA abuse or dependence;
ā. Have a self-reported history of using MA by the smoked or IV route, for at least 2 years.
ā. 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.
ā. 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;
ā. Have a baseline ECG that demonstrates normal sinus rhythm, normal conduction, and no clinically significant arrhythmias;
ā. Be able to fully cooperate with visual field testing to the point that a valid test is obtained during screening/baseline.
Exclusion criteria
ā. Have any history or evidence suggestive of seizure disorder or brain injury;
ā. Have any previous medically adverse reaction to MA, including loss of consciousness, chest pain, or epileptic seizure;
ā. Have neurological or psychiatric disorders, such as:
ā. Have evidence of clinically significant heart disease or hypertension, as determined by the PI;
ā. Have a family history in first-degree relatives of early cardiovascular morbidity or mortality, as determined by the PI;
ā. Have any ophthalmologic disorder (e.g., glaucoma, cataracts, optic nerve disease, fixation problems, etc.) which, in the judgment of the study ophthalmologist, would:
ā. Have evidence of untreated or unstable medical illness including: neuroendocrine, autoimmune, renal, hepatic, or active infectious disease;
ā. Have HIV and are currently symptomatic, have a diagnosis of AIDS, or are receiving antiretroviral medication;