NCT01363180

Brief Summary

This project is the first to use a clinical laboratory method in emerging adults to test the hypothesis that a trauma history with or without concommitant posttraumatic stress disorder (PTSD) alters response to a stressor and promotes drinking compared to normal controls. The study will be the first to explore whether trauma-exposed (TE) and PTSD groups differ on these outcomes. It will also examine the relationship between stress reactivity and subsequent stress-induced drinking in these samples. The goal of this program is to better understand the relationship between stress and factors related to the development and maintenance of alcohol problems in early adults, so that ultimately, better treatments may be developed that reduce the incidence and severity of alcohol related problems.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
197

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 1, 2011

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

June 18, 2018

Status Verified

May 1, 2018

Enrollment Period

5 years

First QC Date

May 27, 2011

Last Update Submit

June 15, 2018

Conditions

Study Arms (3)

Control

Behavioral: Trier Social Stress Test (TSST)Other: No stress condition

Trauma-exposed without PTSD

Behavioral: Trier Social Stress Test (TSST)Other: No stress condition

Trauma-exposed with PTSD

Behavioral: Trier Social Stress Test (TSST)Other: No stress condition

Interventions

The TSST is a standardized psychological stress challenge where a participant performs a speech and mental math task in front of 3 unfamiliar individuals, in order to evoke an HPA axis stress response in a laboratory setting.

ControlTrauma-exposed with PTSDTrauma-exposed without PTSD
ControlTrauma-exposed with PTSDTrauma-exposed without PTSD

Eligibility Criteria

Age21 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

21-30 year olds

You may qualify if:

  • Age: 21-30 years old.
  • Must drink alcohol on at least 4 days in the past month.
  • Must drink beer (thought not necessarily exclusively)
  • Must be able to read and provide informed consent.
  • Trauma history group criteria:
  • To be eligible for Control group, participants must not have a history of Criteria A traumatic event(s), as defined by the DSM-IV.
  • To be eligible for the Trauma-Exposed group (TE), participants must have a history of a Criteria A traumatic event that involves interpersonal violence, but not meet DSM-IV criteria for PTSD (current or lifetime)as defined by the MINI, and a PCL score 20 or below.
  • To be eligible for the PTSD group, participants must have a history of exposure to a Criteria A traumatic event that involves interpersonal violence, currently meet criteria for PTSD (defined by DSM-IV) and a PCL score of 30 or above.

You may not qualify if:

  • Currently taking psychoactive medication, antihistamines, or medication that alters HPA axis functioning.
  • Severe obesity (BMI \> 40)
  • Current alcohol dependence.
  • Current abuse or dependence on illicit substances (with the exceptions of caffeine and nicotine)
  • Smokers who cannot abstain from smoking for at least 4 hours.
  • Current major depression.
  • Current or lifetime psychosis.
  • Any medical condition that impacts HPA axis functioning.
  • Any blood clotting disorder.
  • Pregnant or nursing women, or women who suspect that may be pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Links

MeSH Terms

Conditions

Wounds and InjuriesStress Disorders, Post-Traumatic

Interventions

Psychological Tests

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

  • Carla K Danielson, Ph.D.

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR
  • Suzanne Thomas, Ph.D.

    Medical University of South Carolina

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2011

First Posted

June 1, 2011

Study Start

January 1, 2011

Primary Completion

December 31, 2015

Study Completion

June 1, 2016

Last Updated

June 18, 2018

Record last verified: 2018-05

Locations