Alcohol Self Administration Laboratory

NCT ID: NCT00398918

Last Updated: 2017-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2009-03-31

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.

Conditions

Alcoholism

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Zonisamide

Group Type: EXPERIMENTAL

zonisamide

Intervention Type: DRUG

zonisamide (100 mg)one time

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo Comparator

Interventions

zonisamide

zonisamide (100 mg)one time

Intervention Type: DRUG

Placebo

Placebo Comparator

Intervention Type: DRUG

Other Intervention Names

zonegran

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Boston University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ofra Sarid-Segal, MD

Role: PRINCIPAL_INVESTIGATOR

Boston University

Locations

Boston University Medical Campus

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

H-25360

Identifier Type: -

Identifier Source: org_study_id