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Alcohol Self Administration Laboratory

Primary Purpose

Alcoholism

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

zonisamide

Placebo

About this trial

This is an interventional other trial for Alcoholism

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Boston University Medical Campus

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Zonisamide

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Grams Ethanol Consumed During Second Hour of the Alcohol Self-Administration Sessions

Grams Ethanol Consumed During Second Hour of the Alcohol Self-Administration Sessions for Zonisamide and Placebo Conditions

Secondary Outcome Measures

Score Digit Symbol Modalities Test

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.

Full Information

NCT ID

NCT00398918

First Posted

November 13, 2006

Last Updated

June 17, 2017

Sponsor

Boston University

1. Study Identification

Unique Protocol Identification Number

NCT00398918

Brief Title

Alcohol Self Administration Laboratory

Official Title

Alcohol Self Administration Laboratory

Study Type

Interventional

2. Study Status

Record Verification Date

June 2017

Overall Recruitment Status

Completed

Study Start Date

November 2006 (undefined)

Primary Completion Date

October 2007 (Actual)

Study Completion Date

March 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Boston University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alcoholism

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Non-Randomized

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Zonisamide

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

zonisamide

Other Intervention Name(s)

zonegran

Intervention Description

zonisamide (100 mg)one time

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo Comparator

Primary Outcome Measure Information:

Title

Grams Ethanol Consumed During Second Hour of the Alcohol Self-Administration Sessions

Description

Grams Ethanol Consumed During Second Hour of the Alcohol Self-Administration Sessions for Zonisamide and Placebo Conditions

Time Frame

1 day

Secondary Outcome Measure Information:

Title

Score Digit Symbol Modalities Test

Description

Time Frame

40 minutes post alcohol ingestion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ofra Sarid-Segal, MD

Organizational Affiliation

Boston University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Boston University Medical Campus

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02118

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Alcohol Self Administration Laboratory

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