Alcohol and Other Drug Use DisordersNCT02438254
Texas Family Health Patterns: A Study Across Generations
An observational study of Alcohol and Other Drug Use Disorders, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol and Other Drug Use Disorders
- How many people
- 139 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2014to Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
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-).
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
About this study
Official title: 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.
Read the 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.
- Conditions
- Alcohol and Other Drug Use Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Assess behavioral risk factors in young adults with and without family histories of alcohol and other drug use disorders
Measured: 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
Measured: 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
Measured: 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
Measured: The DNA repository will be maintained over the 5 year study duration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2015 (estimated)
- Study startSep 2014
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol and Other Drug Use DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02438254
- Sponsor's protocol ID
- 14-410H
- Other IDs
- 2R01AA012207-11
- Status last verified
- Jan 2017
- First submitted
- 23 Apr 2015
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oklahoma Family Health Patterns: A Study Across Generations
- ClinicalTrials.gov ID
- NCT02438254
- Acronym / sponsor ID
- 14-410H
- Conditions
- Alcohol and Other Drug Use Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Sep 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 8 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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-).
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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. .
Maintain DNA repository for DNA analyses
Time frame: The DNA repository will be maintained over the 5 year study duration.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcohol and Other Drug Use Disorders, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2017; AzTrials last refreshed its copy on 31 Oct 2026.