| Purpose: |
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The primary aim of the study is to determine the safety and tolerability of treatment with
Varenicline in methamphetamine-dependent volunteers. The investigators also seek to
determine the effects of treatment with Varenicline, as compared to placebo, on craving for
methamphetamine or cigarettes following exposure to methamphetamine and smoking cues,
respectively. The effects of treatment with Varenicline, as compared to placebo, on
subjective effects produced by administration of methamphetamine or placebo will be
attempted to be determined. Lastly, the investigators hope to determine the effects of
treatment with Varenicline, as compared to placebo, on reinforcing effects produced by
administration of methamphetamine or placebo.
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| Criteria: |
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Inclusion Criteria:
- English speaking volunteers who are not seeking treatment at the time of the study;
Be between 18-55 years of age; Meet DSM-IV criteria for MA dependence; Must be
cigarette smokers, defined as smoking 10 or more cigarettes per day by self-report;
Have a self-reported history of using MA by the smoked or IV route and provide at
least one MA-positive urine prior to admission; Have vital signs as follows: resting
pulse between 50 and 90 bpm, blood pressures between 105-150 mm Hg systolic and 45-90
mm HG diastolic; this criterion must be met within 2 days of admission; 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; Have a baseline EKG that
demonstrates normal sinus rhythm, normal conduction (including QTc), and no
clinically significant arrhythmias; Have a medical history and brief physical
examination demonstrating no clinically significant contradictions for study
participation, in the judgment of the admitting physician or nurse practitioner and
the principal investigator
Exclusion Criteria:
- Have any history or evidence suggestive of seizure disorder or brain injury; Have any
previous medically adverse reaction to MA, including loss of consciousness, chest
pain, or epileptic seizure; Have neurological or psychiatric disorders, such as:
•psychosis, bipolar illness or major depression as assessed by 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 MINI
and/or current suicidal ideation/plan as assessed by MINI; Have evidence of
clinically significant heart disease or hypertension, as determined by the PI;Have a
family history in first-degree relatives of early cardiovascular morbidity or
mortality, as determined by the PI; Have evidence of untreated or unstable medical
illness including: neuroendocrine, autoimmune, renal, hepatic, or active infectious
disease; Have HIV and are currently symptomatic, have a diagnosis of AIDS, or are
receiving antiretroviral medication; 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; Have asthma or currently use alpha or beta
agonists, theophylline, or other sympathomimetics; Have any other illness, condition,
or use of psychotropic medications, which in the opinion of the PI and/or the
admitting physician or nurse practitioner would preclude safe and/or successful
completion of the study. |