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Pharmacogenetic Treatments for Alcoholism

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ClinicalTrials.gov Identifier: NCT01591291
Recruitment Status : Unknown
Verified May 2012 by Bankole Johnson, University of Virginia.
Recruitment status was:  Not yet recruiting
First Posted : May 3, 2012
Last Update Posted : May 3, 2012
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Bankole Johnson, University of Virginia

Tracking Information
First Submitted Date  ICMJE April 17, 2012
First Posted Date  ICMJE May 3, 2012
Last Update Posted Date May 3, 2012
Study Start Date  ICMJE June 2012
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 2, 2012)
Percent heavy drinking days [ Time Frame: up to 24 weeks ]
The timeline follow-back (TLFB) method of measuring alcohol consumption will be used to get the percent heavy drinking days.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 2, 2012)
  • Drinks per drinking day [ Time Frame: up to 24 weeks ]
    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 ]
    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 ]
    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) ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pharmacogenetic Treatments for Alcoholism
Official Title  ICMJE 1/2 - Pharmacogenetic Treatments for Alcoholism
Brief Summary

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.

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alcoholism
Intervention  ICMJE
  • Drug: Ondansetron + Brief Behavioral Enhancement Treatment
    Ondansetron 4ug/kg twice daily
    Other Name: Zofran
  • Drug: Placebo + Brief Behavioral Enhancement Treatment
    Placebo twice daily
    Other Name: Sugar Pill
Study Arms  ICMJE
  • Experimental: Ondansetron
    Intervention: Drug: Ondansetron + Brief Behavioral Enhancement Treatment
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo + Brief Behavioral Enhancement Treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 2, 2012)
256
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2018
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01591291
Other Study ID Numbers  ICMJE G15991
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bankole Johnson, University of Virginia
Study Sponsor  ICMJE Bankole Johnson
Collaborators  ICMJE National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators  ICMJE
Principal Investigator: Bankole Johnson, DSc, MD, PhD University of Virginia
PRS Account University of Virginia
Verification Date May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP