Alcohol Self Administration Laboratory - Full Text View

Sponsored by:	Boston University
Information provided by:	Boston University
ClinicalTrials.gov Identifier:	NCT00398918

Purpose

This is a pilot study in which our intent is to establish an alcohol administration laboratory in which we will be able to test the effect of the anticonvulsant medication zonisamide as compared to placebo on alcohol self administration and on cognitive functioning in non treatment seeking heavy users of alcohol. Our first goal is to establish the safety of zonisamide when used together with alcohol. Our second goal is to test the effect of an acute dose of zonisamide on alcohol consumption and show that it may reduce the consumption of alcohol. To achieve this goal we seek subjects with a history of heavy drinking to be tested on the self-administration procedures described below in two sessions with either zonisamide or placebo. These procedures will involve first, the administration of a challenge dose of ethanol to evaluate the effect of alcohol on performance on neuropsychological tests. This initial challenge will be followed by a period of alcohol self-administration in which the research subject can choose to select either ethanol or another reinforcer, money. Secondary objectives of this study are to establish that our method of prediction of alcohol level is accurate and that assessments can be done within our timeline.

Condition	Intervention
Alcoholism	Drug: zonisamide

MedlinePlus related topics: Alcoholism

Drug Information available for: Zonisamide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Non-Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Alcohol Self Administration Laboratory

Further study details as provided by Boston University:

Primary Outcome Measures:

Our first goal is to establish the safety of zonisamide when used together with alcohol. [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Secondary objectives of this study are to establish that our method of prediction of alcohol level is accurate and that assessments can be done within our timeline. [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Estimated Enrollment:	10
Study Start Date:	November 2006
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Zonisamide: Experimental	Drug: zonisamide zonisamide (100 mg)one time

Detailed Description:

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 decreased alcohol consumption in a limited access model in the C57BL/B6 mouse. These results suggest that zonisamide might be useful as a medication for the treatment of alcohol dependence.

Topiramate and zonisamide have some structural similarities with a sulfamate or methane-sulfonamide containing chain respectively attached to cyclic structure. These structural similarities may explain some of their pharmacological similarities including blockade of voltage sensitive sodium channels and low potency inhibition of carbonic anhydrase (Taverna et al., 1999; Dodgson et al., 2000; Schaf et al., 1987; Masudaet al., 1993). Both topiramate and zonisamide promote weight loss (McElroy et al., 2003; McElroy et al., 2004; Gadde et al., 2003). This effect may be a result of neuromodulation of the regulation of alcohol and food shared by these drugs.

Eligibility

Ages Eligible for Study:	21 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Non treatment seeking subjects ages 21-55 must indicate no treatment for alcohol dependence in the preceding 6 months.
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
Subjects must be able to provide IC
BAC must be 0.000 at the time of consent
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:

Subject meeting DSM-IV-TR criteria for axis I diagnosis that require pharmacological treatment.
Subject meeting substance dependence criteria for any substance other than alcohol or nicotine .
Positive urine toxicology screen for opioids, cocaine, amphetamines, PCP, THC (may repeat THC if positive).
History of severe alcohol withdrawals.
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.
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
Subjects on psychoactive medications must be on a stable dose more than 3 months
Female subjects who are pregnant or nursing.
Subject is facing future imprisonment.
A known allergy to zonisamide or sulfa.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00398918

Locations

United States, Massachusetts
Boston University Medical Campus
Boston, Massachusetts, United States, 02118

Sponsors and Collaborators

Boston University

Investigators

Principal Investigator:

Ofra Sarid-Segal, MD

Boston University

More Information

No publications provided

Responsible Party:	Boston University ( Ofra Sarid-Segal, MD )
Study ID Numbers:	H-25360
Study First Received:	November 13, 2006
Last Updated:	March 25, 2009
ClinicalTrials.gov Identifier:	NCT00398918 History of Changes
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Antioxidants
Mental Disorders
Zonisamide
Alcoholism
Substance-Related Disorders

Disorders of Environmental Origin
Alcohol-Related Disorders
Anticonvulsants
Ethanol

Additional relevant MeSH terms:

Antioxidants
Molecular Mechanisms of Pharmacological Action
Zonisamide
Physiological Effects of Drugs
Disorders of Environmental Origin
Protective Agents
Pharmacologic Actions

Mental Disorders
Therapeutic Uses
Alcoholism
Substance-Related Disorders
Alcohol-Related Disorders
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on May 07, 2009