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

Completed · Phase 1 · Has a placebo group

Conditions studied: Alcoholism

In brief

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.

Key facts

Study ID

NCT00769158

Run by

Bankole Johnson

People needed

4

Starts

2008-10-01

Expected to finish

2010-12-01

Last updated by the study team

2012-02-07

Who can join

Age: 21 and older, up to 45. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• UVA CARE — Charlottesville, Virginia, United States
• UVA CARE Richmond — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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