NCT02438254

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
139

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 8, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

February 28, 2017

Status Verified

January 1, 2017

Enrollment Period

2 years

First QC Date

April 23, 2015

Last Update Submit

February 24, 2017

Conditions

Alcohol and Other Drug Use Disorders

Outcome Measures

Primary Outcomes (4)

  • Assess behavioral risk factors in young adults with and without family histories of alcohol and other drug use disorders

    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

    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

    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

    The DNA repository will be maintained over the 5 year study duration.

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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-).

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2015

First Posted

May 8, 2015

Study Start

September 1, 2014

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

February 28, 2017

Record last verified: 2017-01

Locations

US(1)