Trial record 7 of 179 for:    Open Studies | "Alcoholism"

Pharmacogenetic Treatments for Alcoholism

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2012 by University of Virginia
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Bankole Johnson, University of Virginia
ClinicalTrials.gov Identifier:
NCT01591291
First received: April 17, 2012
Last updated: May 2, 2012
Last verified: May 2012
  Purpose

Heavy drinking can cause serious health, family, and economic problems. Finding treatments that are effective in decreasing heavy drinking among alcohol-dependent individuals is, therefore, an important scientific and health goal. A novel and important strategy to enhance alcoholism treatment efforts uses a personalized medicine approach to optimize treatment effects by selecting the "right" patient therapeutically and potentially with a minimum of adverse events, for a specific medication.

This study will extend findings from a randomized double-blind clinical trial of ondansetron, in which the medication was found to reduce drinking among individuals with certain genotypes (i.e., forms of DNA, the material that controls the inheritance of characteristics). The proposed study will address a number of limitations in the prior work, including testing the medication in both European-American and African-American samples.


Condition Intervention Phase
Alcoholism
Drug: Ondansetron + Brief Behavioral Enhancement Treatment
Drug: Placebo + Brief Behavioral Enhancement Treatment
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 1/2 - Pharmacogenetic Treatments for Alcoholism

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Primary Outcome Measures:
  • Percent heavy drinking days [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
    The timeline follow-back (TLFB) method of measuring alcohol consumption will be used to get the percent heavy drinking days.


Secondary Outcome Measures:
  • Drinks per drinking day [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
    From the TLFB data, other measures of drinking such as drinking intensity (drinks per drinking day; DDD) will be derived.

  • Percentage of days abstinent [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
    From the TLFB data, other measures of drinking such as the percentage of days abstinent (PDA) will be derived.

  • Percentage of subjects with no heavy drinking days [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
    The TLFB will also be used for other experimental measures that we have validated in previous studies, such as the percentage of subjects with no heavy drinking.

  • Measures of quality of life [ Time Frame: Various time points in the study (screen, weeks 1, 4, 8, 12, 16, 20, 24) ] [ Designated as safety issue: No ]
    Quality of life will be assessed using the Quality of Life Enjoyment and Satisfaction Questionnaire and Short Index of Problems.

  • Objective measure of treatment measure and adverse event using RNA [ Time Frame: We will collect RNA on screen, weeks 4, 8, 12, 16, 20, 24 ] [ Designated as safety issue: No ]
    We will collect RNA samples and using genome-wide expression studies of total RNA, we will compare 15 of the most responsive and 15 of the most least responsive on percent heavy drinking days and 15 with the most and 15 with the fewest adverse events, we will identify changes that mediate ondansetron's efficacy and adverse event profile, respestively.


Estimated Enrollment: 256
Study Start Date: June 2012
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ondansetron Drug: Ondansetron + Brief Behavioral Enhancement Treatment
Ondansetron 4ug/kg twice daily
Other Name: Zofran
Placebo Comparator: Placebo Drug: Placebo + Brief Behavioral Enhancement Treatment
Placebo twice daily
Other Name: Sugar Pill

Detailed Description:

This study is a 24 week clinical trial. During the 24 weeks participants will receive either ondansetron or placebo. Participants will also receive Brief Behavioral Compliance enhancement Treatment (BBCET) as their psychosocial adjuct weekly in weeks 1 to 12, and then every 2 weeks in weeks 12 to 24. We will enroll two separate population groups (i.e., African-Americans and European-Americans), each with 128 treatment-seeking, alcohol-dependent individuals in a 24-week clinical trial. Subjects in each of these two population groups (N=128/group) will be randomized into 4 cells (N=32/cell) in a 2 (TT vs. TG or GG) × 2 (ondansetron 4 μg/kg twice daily vs. placebo) factorial design. Group assignment will be achieved using a block randomization procedure that balances the treatment groups on PHDD, age, and gender.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females who have given written informed consent
  • Between the ages of 18 and 65 years and weighing within 30% of ideal body weight. Also, patients must weigh at least 40 kg and no more than 155 kg.
  • Good physical health as determined by a complete physical examination, an electrocardiogram (EKG) within normal limits, and laboratory screening tests within acceptable parameters.
  • Current DSM-IV diagnosis of alcohol dependence
  • AUDIT score of ≥8
  • Currently drinking ≥14 alcohol units/week for women and ≥21 alcohol units/week for men in the last 30 days, and have met this criteria prior to randomization
  • Provide evidence of stable residence in the last month prior to enrollment in the study, and have no plans to move in the next 9 months.
  • Literate in English and able to read, understand, and complete the rating scales and questionnaires accurately, follow instructions, and make use of the behavioral treatments
  • Expressed a wish to reduce or stop drinking
  • Willingness to participate in behavioral treatments for alcoholism

Exclusion Criteria:

  • Please contact site for additional information
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01591291

Contacts
Contact: Mindy Borszich 1-888-882-2345 mcb3x@virginia.edu

Locations
United States, Virginia
University of Virginia Center for Addiction Research and Education Not yet recruiting
Charlottesville, Virginia, United States, 22911
Contact: Mindy Borszich    888-882-2345    mcb3x@virginia.edu   
Contact: Eva Jenkins-Mendoza    (434)243-0562    emj9c@virginia.edu   
Principal Investigator: Bankole Johnson, DSc, MD, PhD         
Sub-Investigator: Nassima Ait-Daoud Tiouririne, MD         
University of Virginia Center for Addiction Research and Education Not yet recruiting
Richmond, Virginia, United States, 23294
Contact: Mindy Borszich    888-882-2345    mcb3x@virginia.edu   
Contact: Eva Jenkins-Mendoza    (434)243-0562    emj9c@virginia.edu   
Principal Investigator: Bankole Johnson, DSc, MD, PhD         
Sub-Investigator: Nassima Ait-Daoud Tiouririne, MD         
Sponsors and Collaborators
Bankole Johnson
Investigators
Principal Investigator: Bankole Johnson, DSc, MD, PhD University of Virginia
  More Information

No publications provided

Responsible Party: Bankole Johnson, Chair of Psychiatry and Neurobehavioral Sciences, University of Virginia
ClinicalTrials.gov Identifier: NCT01591291     History of Changes
Other Study ID Numbers: G15991
Study First Received: April 17, 2012
Last Updated: May 2, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Virginia:
alcohol dependence
alcohol addiction

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Ondansetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents

ClinicalTrials.gov processed this record on August 01, 2014