Alcohol Self Administration Laboratory

NCT00398918 | Completed Results

• 1 other identifier: H-25360
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcoholism

Outcome Measures

Primary Outcomes (1)

• 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

  1 day

Secondary Outcomes (1)

• Score Digit Symbol Modalities Test

  40 minutes post alcohol ingestion

Study Arms (2)

Zonisamide

EXPERIMENTAL

Drug: zonisamide

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

zonisamide DRUG

zonisamide (100 mg)one time

Also known as: zonegran

Zonisamide

Placebo DRUG

Placebo Comparator

Placebo

Eligibility Criteria

• Age: 21 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston University: lead

Study Sites (1)

Boston University Medical Campus

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Zonisamide

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Ofra Sarid-Segal, MD
• Organization: Boston University

ofra.segal@bmc.org

617-414-1990

Study Officials

• Ofra Sarid-Segal, MD

  Boston University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2006
• First Posted: November 14, 2006
• Study Start: November 1, 2006
• Primary Completion: October 1, 2007
• Study Completion: March 1, 2009
• Last Updated: July 14, 2017
• Results First Posted: May 14, 2010

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)