A New Pharmacotherapy for Alcohol Dependence: Olanzapine - Full Text View

Sponsor:	University of New Mexico
Information provided by:	University of New Mexico
ClinicalTrials.gov Identifier:	NCT00746785

Purpose

Craving for alcohol has been related to loss of control drinking and is a major target of biological and behavioral interventions for alcohol dependence. Our previous research has demonstrated that olanzapine (a dopamine antagonist) attenuates craving for alcohol, that a variant in the gene that expresses D4 receptors influences craving for alcohol, and that olanzapine is particularly effective at reducing craving among individuals with this variant. Pilot data from a recent 12 week trial of olanzapine indicates that olanzapine is well tolerated and that olanzapine reduces drinking, particularly among individuals with the aforementioned genetic variant. The objective of the present application is to examine the effectiveness of olanzapine (5 mg/day), as compared to olanzapine (2.5 mg/day) and a placebo control, in terms of reducing craving and alcohol use behavior among treatment seeking alcoholics. Furthermore, the present application will examine whether the effects of olanzapine on drinking outcomes are mediated by its effects on a specific putative mechanism (i.e., cue-elicited craving for alcohol) and determine whether the DRD4 VNTR polymorphism is a marker for the effectiveness of olanzapine. To that end, 202 alcohol dependent subjects will be randomly assigned to medication group and receive 12 weeks of medication. Subjects will complete follow-up assessments at 3 and 6 months after the end of the treatment. It is expected that olanzapine will significantly reduce cue-elicited craving and alcohol use behavior in a dose dependent fashion over the course of the 12 week trial and follow-up period, as compared to the placebo condition. Furthermore, it is expected that the effects of olanzapine on alcohol use behavior will be mediated by the effect of olanzapine on cue-elicited craving and that the effects of olanzapine on cue-elicted craving and alcohol use behavior will be moderated by the DRD4 VNTR, such that olanzapine will be more effective among individuals with the 7 repeat allele. The successful completion of the proposed research is expected to advance a new medication for alcohol dependence and advance genetic markers that predict the effectiveness of this medication.

Condition	Intervention	Phase
Alcohol Dependence	Drug: olanzapine Drug: placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Pharmacodynamics Study
Official Title:	A New Pharmacotherapy for Alcohol Dependence: Olanzapine

Resource links provided by NLM:

MedlinePlus related topics: Alcohol Alcoholism

Drug Information available for: Olanzapine

U.S. FDA Resources

Further study details as provided by University of New Mexico:

Primary Outcome Measures:

Drinks per drinking day [ Time Frame: at each appointment ] [ Designated as safety issue: No ]

Estimated Enrollment:	192
Study Start Date:	September 2002
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental 2.5 mg Olanzapine	Drug: olanzapine 2.5 mg
B: Active Comparator 5 mg Olanzapine	Drug: olanzapine 5 mg
C: Placebo Comparator	Drug: placebo placebo

Show Detailed Description

Eligibility

Ages Eligible for Study:	21 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

21-55 years of age with
Alcohol Dependence

Exclusion Criteria:

Medical Contraindications

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00746785

Contacts

Contact: Sarah W Feldstein Ewing, Ph.D.	505-925-4743	sfeldstein@mrn.org
Contact: Jessie Otoski, B.S.	505-272-4444	jotoski@mrn.org

Locations

United States, New Mexico
The Mind Research Network	Recruiting
Albuquerque, New Mexico, United States, 87131
Principal Investigator: Kent E Hutchison, Ph.D.

Sponsors and Collaborators

University of New Mexico

Investigators

Principal Investigator:

Kent E Hutchison, Ph.D.

The Mind Research Network

More Information

No publications provided

Responsible Party:	The Mind Research Network ( Kent Hutchison, Ph.D.; Professor of Psychology and Neurosciences, University of New Mexico; Director of the Neurogenetics Core, The Mind Research Network )
Study ID Numbers:	5RO1AA014886
Study First Received:	September 2, 2008
Last Updated:	September 3, 2008
ClinicalTrials.gov Identifier:	NCT00746785 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of New Mexico:

Olanzapine

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Gastrointestinal Agents
Psychotropic Drugs
Olanzapine
Antiemetics
Disorders of Environmental Origin
Central Nervous System Depressants
Antipsychotic Agents

Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Agents
Autonomic Agents
Mental Disorders
Therapeutic Uses
Alcoholism
Substance-Related Disorders
Alcohol-Related Disorders
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010