Alcohol Self Administration Laboratory

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00398918
Recruitment Status : Completed
First Posted : November 14, 2006
Results First Posted : May 14, 2010
Last Update Posted : July 14, 2017
Information provided by (Responsible Party):
Boston University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Alcoholism Drug: zonisamide Drug: Placebo Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Alcohol Self Administration Laboratory
Study Start Date : November 2006
Actual Primary Completion Date : October 2007
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Zonisamide

Arm Intervention/treatment
Experimental: Zonisamide Drug: zonisamide
zonisamide (100 mg)one time
Other Name: zonegran

Placebo Comparator: Placebo Drug: Placebo
Placebo Comparator

Primary Outcome Measures :
  1. Grams Ethanol Consumed During Second Hour of the Alcohol Self-Administration Sessions [ Time Frame: 1 day ]
    Grams Ethanol Consumed During Second Hour of the Alcohol Self-Administration Sessions for Zonisamide and Placebo Conditions

Secondary Outcome Measures :
  1. Score Digit Symbol Modalities Test [ Time Frame: 40 minutes post alcohol ingestion ]
    Difference score between zonisamide and placebo treatment conditions for the Digit Symbol Modalities Test scores obtained 40 minutes after ingestion of a priming dose of ethanol.This test involves transcribing from a key in which numbers appear below a series of symbols to boxes below symbols matched to those in the key. This task must be completed in 90 nseconds. This test measures visuomotor speed and aspects of attention. Scoring is the total number of correctly transcribed numbers. The maximum score on this test 110 points.

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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00398918

United States, Massachusetts
Boston University Medical Campus
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
Boston University
Principal Investigator: Ofra Sarid-Segal, MD Boston University

Responsible Party: Boston University Identifier: NCT00398918     History of Changes
Other Study ID Numbers: H-25360
First Posted: November 14, 2006    Key Record Dates
Results First Posted: May 14, 2010
Last Update Posted: July 14, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs