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

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: NCT00769158
Recruitment Status : Completed
First Posted : October 8, 2008
Last Update Posted : February 7, 2012
Information provided by (Responsible Party):
Bankole Johnson, University of Virginia

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Alcoholism Drug: Topiramate and Naltrexone Other: Placebo Phase 1

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  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Combining Medications for the Treatment of Alcohol Dependence: An Inpatient Preliminary Study
Study Start Date : October 2008
Actual Primary Completion Date : October 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Topiramate + Naltrexone
Combination of Topiramate and Naltrexone
Drug: Topiramate and Naltrexone
Topiramate 200 mg and Naltrexone 50 mg
Other Name: Topamax and Revia
Placebo Comparator: Placebo Other: Placebo
Placebo Comparator
Other Name: Sugar Pill

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT00769158

United States, Virginia
Charlottesville, Virginia, United States, 22911
UVA CARE Richmond
Richmond, Virginia, United States, 23294
Sponsors and Collaborators
Bankole Johnson
Principal Investigator: Bankole Johnson, DSc,MD.PhD University of Virginia

Responsible Party: Bankole Johnson, Chair of Psychiatry and Neurobehavioral Sciences, University of Virginia Identifier: NCT00769158     History of Changes
Other Study ID Numbers: 13521
First Posted: October 8, 2008    Key Record Dates
Last Update Posted: February 7, 2012
Last Verified: February 2012

Keywords provided by Bankole Johnson, University of Virginia:
Alcohol Dependence

Additional relevant MeSH terms:
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Narcotic Antagonists
Sensory System Agents
Peripheral Nervous System Agents
Neuroprotective Agents
Protective Agents
Anti-Obesity Agents