- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02438254
Texas Family Health Patterns: A Study Across Generations
Oklahoma Family Health Patterns: A Study Across Generations
The researchers are studying factors that may increase the risk for alcohol and drug use in individuals who do not have any problems with these substances. This study will be looking at health behaviors in young adults compared to their family's health behaviors and lifestyle.
The investigators plan to study genetic differences in people with and without a family history of alcoholism. The researchers hope to learn how a family history of alcoholism, early life adversity and different genotypes shape personal characteristics associated with a risk for alcoholism.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Texas
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San Antonio, Texas, United States, 78229
- University of Texas Health Science Center at San Antonio
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Male or female sex
- Age 18-29 years
- Normal health based on routine history and physical
- Willingness to provide a DNA sample
- No required CNS-acting medications, history of neurological impairment, or diabetes mellitus
- Normal color vision
- Normal intelligence based on Shipley Institute of Living verbal scale score ≥ 20 (John & Rattan, 1992)
- Negative urine drug screen at entry and each lab visit (icup, Alcopro, Knoxville, TN) and alcohol breath test (AlcoMate CA2000, KHN Solutions, San Francisco)
- Volunteers must have been raised by at least one biological parent and have knowledge of and contact with same
Exclusion Criteria:
- Pregnancy
- Any failure to meet inclusion criteria
- Rearing by other than a biological parent
- Suspected maternal alcoholism during pregnancy with proband, determined by interview with subject or parent
- AUDIT score > 12
- Inability of parent to provide credible report of family alcohol use patterns for two generations
- Current Axis I disorder by DIS-IV, excepting past depression or abuse of alcohol or drugs (all > 60 days)
- Axis II disorder in Clusters A or C by SCID II. AXIS II symptoms in Cluster B are not exclusionary because antisocial and behavioral undercontrol variables related to substance use disorders overlap with Cluster B symptoms. Past abuse of alcohol and other substances is not exclusionary in order to allow a wide range of intake while still avoiding severe consequences of intake history.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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FH+
Young adults with at least one parent with an alcohol or other drug use disorder history.
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FH-
Young adults with no histories of alcohol or other drug use disorders in any parents or grandparents.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Assess behavioral risk factors in young adults with and without family histories of alcohol and other drug use disorders
Time Frame: Participants will be assessed on 3 laboratory visits lasting a few hours each. All 3 visits will typically be competed within 3-4 weeks.
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Participants will be assessed on 3 laboratory visits lasting a few hours each. All 3 visits will typically be competed within 3-4 weeks.
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Collect physiological measures of stress reactivity in young adults with and without family histories of alcohol and other drug use disorders
Time Frame: Participants will be assessed on 3 laboratory visits lasting a few hours each. All 3 visits will typically be competed within 3-4 weeks.
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Participants will be assessed on 3 laboratory visits lasting a few hours each. All 3 visits will typically be competed within 3-4 weeks.
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Collect DNA in young adults with and without family histories of alcohol and other drug use disorders
Time Frame: DNA will be collected once during one of the participants' 3 laboratory visits lasting a few hours each. All 3 visits will typically be competed within 3-4 weeks. .
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DNA will be collected once during one of the participants' 3 laboratory visits lasting a few hours each. All 3 visits will typically be competed within 3-4 weeks. .
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Maintain DNA repository for DNA analyses
Time Frame: The DNA repository will be maintained over the 5 year study duration.
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The DNA repository will be maintained over the 5 year study duration.
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-410H
- 2R01AA012207-11 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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