Alcohol Self Administration Laboratory

Launched by BOSTON UNIVERSITY · Nov 13, 2006

Keywords

ClinConnect Summary

In preclinical studies three novel anticonvulsants have been studied. The administration of tiagabine did not decrease ethanol consumption in rodents (Schmitt et al., 2002; Rimondini et al., 2002). In a study with alcohol preferring mice topiramate reduced alcohol consumption in a two bottle choice prolonged access model of drinking (Gabriel and Cunningham, 2005). In a study done at our laboratory both topiramate and zonisamide were found to have similar effects on reducing the consumption of ethanol in Wistar rat (Knapp et al., 2004). More recently we found that zonisamide administration d...

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Eligibility criteria

• Inclusion Criteria:
• • 1. Non treatment seeking subjects ages 21-55 must indicate no treatment for alcohol dependence in the preceding 6 months.
• • 2. Male subjects must drink no more than 40 standard drinks; female subjects no more than 35 standard drinks a week as determined by the TLFB
• • 3. Subjects must be able to provide IC
• • 4. BAC must be 0.000 at the time of consent
• • 5. Female subjects of a child bearing potential must use an acceptable method of contraception which includes a barrier and spermicide, levonorgestrel implant, medroxyprogesterone, intrauterine progesterone contraceptive system or complete abstinence or surgical sterilization. Women who are using oral contraceptives must agree to an additional barrier method.
• Exclusion Criteria:
• • 1. Subject meeting DSM-IV-TR criteria for axis I diagnosis that require pharmacological treatment.
• • 2. Subject meeting substance dependence criteria for any substance other than alcohol or nicotine .
• • 3. Positive urine toxicology screen for opioids, cocaine, amphetamines, PCP, THC (may repeat THC if positive).
• • 4. History of severe alcohol withdrawals.
• • 5. Any medical or psychological condition that in the opinion of the investigator will preclude safe participation in the trial. These include a history of kidney stones in the past 10 years, significant liver disease with AST and ALT more than 3 times the normal range.
• • 6. Concomitant medications that will alter the pharmacodynamic/pharmacokinetic properties of the study medication. Participant who are taking the following medications: Amprenavir; Atazanavir; Clarithromycin; Delavirdine; Diclofenac; Fosamprenavir; Imatinib; Indinavir; Isoniazid; Itraconazole; Ketoconazole; Miconazole; Nefazodone; Nelfinavir; NiCARdipine; Propofol; Quinidine; Ritonavir; Telithromycin; Phenytoin; carbamazepine and phenobarbital
• • 7. Subjects on psychoactive medications must be on a stable dose more than 3 months
• • 8. Female subjects who are pregnant or nursing.
• • 9. Subject is facing future imprisonment.
• • 10. A known allergy to zonisamide or sulfa.