Texas Family Health Patterns: A Study Across Generations

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Completed

Conditions

Alcohol and Other Drug Use Disorders

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT02438254
2R01AA012207-11 (U.S. NIH Grant/Contract)
14-410H

Details and patient eligibility

About

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.

Full 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.

Enrollment

139 patients

Sex

All

Ages

18 to 30 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

139 participants in 2 patient groups

FH+
Description:
Young adults with at least one parent with an alcohol or other drug use disorder history.
FH-
Description:
Young adults with no histories of alcohol or other drug use disorders in any parents or grandparents.

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems