Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1
INTERVENTIONAL
2008-01-31
2008-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
QUADRUPLE
Study Groups
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Placebo
Matching oral placebo capsules as control.
Placebo
Matching oral placebo capsules as control.
Varenicline
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Varenicline
Varenicline (oral capsule): 0.5 mg once daily for 3 days; 0.5 mg twice daily for 2 days; 1 mg twice daily for one day; 1 mg once daily for one day.
Interventions
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Varenicline
Varenicline (oral capsule): 0.5 mg once daily for 3 days; 0.5 mg twice daily for 2 days; 1 mg twice daily for one day; 1 mg once daily for one day.
Placebo
Matching oral placebo capsules as control.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
55 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Baylor College of Medicine
OTHER
Responsible Party
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Richard De La Garza
Associate Professor
Principal Investigators
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Richard De La Garza, II, PhD
Role: PRINCIPAL_INVESTIGATOR
Baylor College of Medicine
Countries
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Other Identifiers
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