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

NCT00769158 | Completed Phase 1 DMC

• 1 other identifier: 13521
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

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.

Conditions

Alcoholism

Keywords

Alcohol; Alcoholism; Alcohol Dependence

Outcome Measures

Primary Outcomes (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.

  Throughout the study

Study Arms (2)

Topiramate + Naltrexone

EXPERIMENTAL

Combination of Topiramate and Naltrexone

Drug: Topiramate and Naltrexone

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

Topiramate and Naltrexone DRUG

Topiramate 200 mg and Naltrexone 50 mg

Also known as: Topamax and Revia

Topiramate + Naltrexone

Placebo OTHER

Placebo Comparator

Also known as: Sugar Pill

Placebo

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Bankole Johnson: lead

Study Sites (2)

UVA CARE

Charlottesville, Virginia, 22911, United States

Location

UVA CARE Richmond

Richmond, Virginia, 23294, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Topiramate; Naltrexone; Sugars

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Carbohydrates; Ketoses; Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Bankole Johnson, DSc,MD.PhD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chair of Psychiatry and Neurobehavioral Sciences

Study Record Dates

• First Submitted: October 6, 2008
• First Posted: October 8, 2008
• Study Start: October 1, 2008
• Primary Completion: October 1, 2010
• Study Completion: December 1, 2010
• Last Updated: February 7, 2012

Record last verified: 2012-02

Locations

US (2)