Combining Medications for the Treatment of Alcohol Dependence: An Inpatient Preliminary Study
Overview
- Phase
- Phase 1
- Intervention
- Topiramate and Naltrexone
- Conditions
- Alcoholism
- Sponsor
- Bankole Johnson
- Enrollment
- 4
- Locations
- 2
- Primary Endpoint
- 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.
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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.
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.
Investigators
Bankole Johnson
Chair of Psychiatry and Neurobehavioral Sciences
University of Virginia
Eligibility Criteria
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
Arms & Interventions
Topiramate + Naltrexone
Combination of Topiramate and Naltrexone
Intervention: Topiramate and Naltrexone
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
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