Combining Medications for the Treatment of Alcohol Dependence: An Inpatient Preliminary Study

February 3, 2012 updated by: Bankole Johnson
We propose to conduct an inpatient pilot study to test the safety and potential efficacy of topiramate and naltrexone in combination for the treatment of alcoholism.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Eight (n = 8) alcohol-dependent research volunteers, not seeking treatment, will complete a placebo-controlled, within-subject cross-over design in which alcohol-related and control cues are presented as stimuli to induce alcohol-seeking behavior under controlled laboratory conditions after repeated dose (chronic) treatment with double-blind doses of placebo or topiramate + naltrexone.Subjects will reside in an inpatient environment for two separate 9-day blocks interspersed by a 1-week washout period. During separate blocks, topiramate + naltrexone and placebo doses will be administered orally on a twice-daily regimen (08:00 h and 20:00 h) for 8 days.Doses will start the evening of day 1 and the last dose will be given the morning of day 8. No doses will be given the evening of day 8 or the morning of day 9. On Days 7 and 8 of the dosing regimen, subjects will receive alcohol and alcohol-related cues or the corresponding control cues.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • UVA CARE
      • Richmond, Virginia, United States, 23294
        • UVA CARE Richmond

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • DSM-IV-R diagnosis of alcohol dependence.
  • Currently drinking.
  • Good physical health as determined by a complete physical examination, electrocardiogram within normal limits
  • Negative pregnancy test at intake. Women of childbearing potential will be placed on oral contraceptives and also will be expected to use barrier and spermicide as an additional form of contraception if sexually active.
  • Literate in English language, and able to read, understand, and complete rating scales and questionnaires accurately.
  • Willingness to comply with study procedures and protocol including agreement to overnight stay at the human laboratory. Compliance with the alcohol, tobacco, and drug-free environment regulations at the human laboratory is also a condition of enrollment.
  • Written informed consent.

Exclusion Criteria:

  • Expression of desire for immediate treatment for alcohol or drug addiction.
  • History of mental illness that warrants treatment or would preclude safe participation in the protocol except nicotine dependence, as determined by mental status and psychiatric interview using the Structured Clinical Interview for DSM-IV.
  • Acute or chronic organic brain syndrome, schizophrenia, bipolar disorder, or any psychotic disorder.
  • Significant medical illness as determined by history and/or complete physical examination.
  • Uncontrolled uterine or cervical bleeding.
  • History of blood clots.
  • Past problems with oral contraceptive pills.
  • Gross neurological disease.
  • Mental retardation.
  • Neurocognitive functioning >1.5 standard deviation below expected range. If neurocognitive functioning test is >1.5 standard deviation below expected range
  • Clinically significant abnormalities on the electrocardiogram
  • History of ischemic heart disease or myocardial infarction.
  • History of glaucoma or uncontrolled symptomatic thyroid disease.
  • Current infective hepatitis as evidenced by clinical manifestations. If hepatitis is suspected, a hepatitis antibody/antigen screen will be done.
  • Positive pregnancy test.
  • Women 35 and above who smoke will be excluded from participating in this research study.
  • Participation in a human laboratory or clinical study within the last 30 days.
  • Clinically significant laboratory screening test (LST) results on hematology, chemistry, or urine analysis.
  • History of any severe or life-threatening reaction to topiramate or naltrexone
  • Past or current history of seizures disorder.
  • Past or current history of kidney stones.
  • Use of any carbonic anhydrase medication.
  • Being treated with any medication with potential interactions with alcohol or naltrexone.
  • Pending imprisonment.
  • For smokers, previous adverse reaction to nicotine patch
  • Reporting no experience of craving for alcohol
  • Postmenopausal women will not be recruited into this study.
  • Chronic use of NSAIDs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
Placebo Comparator
Other Names:
  • Sugar Pill
Experimental: Topiramate + Naltrexone
Combination of Topiramate and Naltrexone
Drug: Topiramate and Naltrexone
Topiramate 200 mg and Naltrexone 50 mg
Other Names:
  • Topamax and Revia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess the safety of this novel combination of topiramate and naltrexone. To evaluate the efficacy of topiramate and naltrexone in combination for the treatment of alcoholism.
Time Frame: Throughout the study
Throughout the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bankole Johnson

Investigators

  • Principal Investigator: Bankole Johnson, DSc,MD.PhD, University of Virginia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

October 6, 2008

First Submitted That Met QC Criteria

October 6, 2008

First Posted (Estimate)

October 8, 2008

Study Record Updates

Last Update Posted (Estimate)

February 7, 2012

Last Update Submitted That Met QC Criteria

February 3, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13521

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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