Combination of Dronabinol and Clonidine for Cannabis Dependence in Patients With Schizophrenia

Exclusion Criteria

• •1. Current diagnosis of other drug or alcohol dependence (excluding nicotine)
• •2. significant cardiac disease as indicated by history or suspected by abnormal ECG or history of cardiac symptoms
• •3. Positive and Negative Syndrome Scale (PANSS) subscale for positive symptoms of psychosis item \> 3 (moderate) at baseline evaluation
• •4. current medical condition that could prevent regular study attendance
• •5. liver function tests \>3 times the upper limit of normal range
• •6. history of seizure disorder or history of head trauma or CNS insult that could predispose the subject to seizures
• •7. taking clozapine
• •8. current suicidal risk
• •9. bradycardia less than or equal to 50 bpm, supine blood pressure of less than or equal to 100/65, a seated blood pressure of less than or equal to 90/60, or orthostatic change of \>20 systolic or \>10 diastolic on standing, at screening or any pre-dose assessment, or symptoms attributable to low BP (i.e. lightheadedness or dizziness on standing)
• •10. mental retardation or organic mental disorder
• •11. currently in a residential treatment setting in which substance use is monitored and restricted, since the restricted access to drugs could represent an important confounding variable
• •12. pregnant, nursing, or, if a woman of childbearing potential, not using a form of birth control judged by the investigator to be effective
• •13. concomitant treatment with opioid analgesics, sedative hypnotics, or other known CNS depressants
• •14. known hypersensitivity to cannabinoids or sesame oil or clonidine
• •15. disease of the gastrointestinal system, liver, or kidneys that may impede metabolism or excretion of dronabinol
• •16. inability to read or write in English that would hinder their ability to follow study procedures
• •17. history of seizures or a family history of seizures.