Texas Family Health Patterns: A Study Across Generations

February 24, 2017 updated by: The University of Texas Health Science Center at San Antonio

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

The Oklahoma Family Health Patterns project is an intensive study of psychological, behavioral, and stress reactivity characteristics in healthy young adults with a family history of alcoholism (FH+) with a goal of identifying characteristics that place these persons at elevated risk for the disorder. The investigators have recently identified early life adverse experience (ELA), including physical and sexual abuse and separation from parents, as occurring with disproportionate impact in FH+, and the investigators have shown that ELA accounts for diminished stress reactivity, behavioral impulsivity, and poor mood regulation, all of which are risk factors for alcohol and other substance use disorders. The impact of ELA in the FH+ population demands to be studied further in a Gene x Environment interaction given the known positive feedbacks between FH+ and ELA. The investigators' goal is to carry out a G x E interaction study by genotyping the investigators' FH x ELA and examining the impact of genotype on the broad range of personal characteristics currently under study in this project. Aim 1. Examine the differential impact of ELA on psychological and behavioral characteristics of FH+ vs. FH- groups using an expanded sample of volunteers. Aim 2. Use the investigators' larger sample to carry out a Gene x Environment analysis to test specific alleles that are strongly suspected of influencing activity in brain motivational systems, expanding on work the investigators initiated with NIAAA thanks to a supplement to this R01 (AA012207-S1). Aim 3. Test specific aspects of temperament as endophenotypes linking FH and ELA to behavioral, cognitive, and stress reactivity as aspects of the person's phenotype. Aim 4. Increase the investigators' recruitment base by screening and testing volunteers at a second site, the University of Texas HSC, San Antonio, where the investigators currently conduct our neuroimaging studies. Alcoholism is a costly burden to society, but risk factors for alcoholism are poorly understood. The vast majorities of studies focuses on alcoholic patients but are unable to disentangle preexisting influences from the effects of alcohol intake history. The investigators' high-risk study design can be of value by contrasting FH+ and FH- with regard to environmental contributors and genetic vulnerabilities that contribute to behavioral risk factors.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
139

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78229
        • University of Texas Health Science Center at San Antonio

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy young adults with at least one parent with an alcohol or other drug use disorder history (FH+) or no alcohol or other drug use disorders in any parents or grandparents (FH-).

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
FH+
Young adults with at least one parent with an alcohol or other drug use disorder history.
FH-
Young adults with no histories of alcohol or other drug use disorders in any parents or grandparents.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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.
Participants will be assessed on 3 laboratory visits lasting a few hours each. All 3 visits will typically be competed within 3-4 weeks.
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.
Participants will be assessed on 3 laboratory visits lasting a few hours each. All 3 visits will typically be competed within 3-4 weeks.
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. .
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. .
Maintain DNA repository for DNA analyses
Time Frame: The DNA repository will be maintained over the 5 year study duration.
The DNA repository will be maintained over the 5 year study duration.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The University of Texas Health Science Center at San Antonio

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 23, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 8, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 28, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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