Dose Response of Mirtazapine to Methamphetamine Induced Interest, Mood Elevation and Reward

This is an interventional treatment trial for Amphetamine Dependence focused on measuring Human volunteers, amphetamine dependence Read More

Inclusion Criteria:

• 18 -45 years old
• healthy human volunteers
• no history of pre-existing physical (including cardiovascular) illness
• no history of drug abuse or dependence (defined below)
• ability to read and write

Exclusion Criteria:

• pregnant
• any psychotropic medication

• criteria for active substance abuse or dependence based on the DSM-IV: For substance abuse: A maladaptive pattern of substance use leading to clinically significant impairment or distress, as manifested by one (or more) of the following, occurring within a 12-month period:

  1. recurrent substance use resulting in a failure to fulfill major role obligations at work, school, home (e.g., repeated absences or poor work performance related to substance use; substance-related absences, suspensions, or expulsions from school; neglect of children or household)
  2. recurrent substance use in situations in which it is physically hazardous (e.g., driving an automobile or operating a machine when impaired by substance use)
  3. recurrent substance-related legal problems (e.g., arrests for substance-related disorderly conduct)
  4. continued substance use despite having persistent or recurrent social or interpersonal problems caused or exacerbated by the effects of the substance (e.g., arguments with spouse about consequences of intoxication, physical fights)
• The symptoms have never met the criteria for Substance Dependence for this class of substances.

• For substance dependence: A maladaptive pattern of substance use, leading to clinically significant impairment or distress, as manifested by three (or more) of the following, occurring at any time in the same 12-month period:

  1. tolerance, as defined by either of the following:

     1. a need for markedly increased amounts of the substance to achieve intoxication or desired effect
     2. markedly diminished effect with continued use of the same amount of substance

  2. withdrawal, as manifested by either of the following:

     1. the characteristic withdrawal syndrome for the substance
     2. the same (or a closely related) substance is taken to relieve or avoid withdrawal symptoms
  3. the substance is often taken in larger amounts or over a longer period than was intended
  4. there is a persistent desire or unsuccessful efforts to cut down or control substance use
  5. a great deal of time is spent in activities to obtain the substance, use the substance, or recover from its effects
  6. important social, occupational or recreational activities are given up or reduced because of substance use

  7. the substance use is continued despite knowledge of having a persistent or recurrent physical or psychological problem that is likely to have been caused or exacerbated by the substance (e.g., continued drinking despite recognition that an ulcer was made worse by alcohol consumption) on any stimulant medication including:

     • Amphetamine (Adderall®, Adderall XR®)
     • Dextroamphetamine (Dexedrine®)
     • Methamphetamine (Desoxyn®)
     • Dexmethylphenidate (Focalin®, Focalin® XR)
     • Diethylpropion (Tenuate®, Tenuate Dospan®)
     • Methylphenidate (Metadate CD®, Ritalin LA®, Methylin®, Ritalin®, Metadate ER®, Ritalin SR®, Methylin ER®, Daytrana®, Concerta®)
     • Pemoline (Cylert®)
     • Benzphetamine (Didrex®)
     • Phendimetrazine (Adipost®, Bontril®, Melfiat®, Prelu-2®, X-Trozine LA®, Bontril PDM®, Obezine®, Obezine caplets) ®
     • Phentermine (Ionamin®, Phentride®, Teramine®, Adipex-P®)
     • Sibutramine (Meridia®)
     • Caffeine (No Doz®, Quick-Pep®, Vivarin®, Caffedrine®,Caffeine and sodium benzoate inj, Cafcit®)
     • Doxapram (Dopram®)
     • Modafinil (Provigil®)
     • Cocaine
     • MDMA (Ecstasy)
     • MDA
• history of hypertension (BP > 140/90 mm Hg) or systolic hypotension (BP <90/75 mm Hg).
• Subjects with resting pulse rate >90/min.
• any active medical illness
• Subjects known to have clinically significant medical conditions, as determined by complete physical examination, or, a past or current history of the following conditions (including but not limited to):
• cerebrovascular accident or transient ischemic attack;
• ischemic heart disease or myocardial infarction;
• symptomatic coronary artery disease or peripheral vascular disease;
• malignancy or history of malignancy within the past 5 years (except basal cell carcinoma);
• renal disease and/or impaired renal function as defined by subjects with a creatinine clearance of £60 ml/min/24hrs;
• diseases of the gastrointestinal system including active liver disease or current active hepatitis;
• subjects with AST and/or ALT >2 times the upper limit of the normal range and/or an increased serum bilirubin >2 times the upper limit of normal at screening;
• pulmonary disorders
• endocrinological disorders including thyroid disorders;
• gross neurological disorders including subjects with seizure disorders and subjects with progressive or degenerative neurological disorders (e.g., multiple sclerosis)