Stress-induced Drinking in Emerging Adults: the Role of Trauma History (ARC5)

June 15, 2018 updated by: Medical University of South Carolina
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.

Study Overview

Detailed Description

This study will be conducted with a 3 x 2 between subjects design. The between groups factors are (1) trauma group (3 levels: Control, Trauma Exposed with, and without PTSD) and (2) exposure to stress (2 levels: yes and no). To decrease intra-group variability, trauma type will be limited to interpersonal trauma. Potential participants will be screened over the phone. Those meeting basic eligibility criteria will complete an assessment at the MUSC Institute of Psychiatry, and those meeting final eligibility criteria will be scheduled for the laboratory session to be completed at the Clinical and Translational Research Center (CTRC).

Half of each trauma history group will receive the Trier Social Stress Test (TSST); the other half will receive a no-stress control condition. Baseline and post-stress objective and subjective measures of stress reactivity will be collected. Following the stress task, all participants will be given a priming dose and subsequently presented with an alcohol taste test. The primary analyses will examine the effect of trauma group membership on response to stress and subsequent voluntary drinking. Based on power analyses using preliminary data from similar samples, a sample size of 240 participants (40 per cell) is required.

Study Type

Observational

Enrollment (Actual)

197

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

    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina

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

Ages Eligible for Study

21 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

21-30 year olds

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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
Intervention / Treatment
Control
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.
Trauma-exposed without PTSD
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.
Trauma-exposed with PTSD
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.

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Carla K Danielson, Ph.D., Medical University of South Carolina
  • Study Director: Suzanne Thomas, Ph.D., Medical University of South Carolina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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 (Actual)

January 1, 2011

Primary Completion (Actual)

December 31, 2015

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

May 27, 2011

First Submitted That Met QC Criteria

May 31, 2011

First Posted (Estimate)

June 1, 2011

Study Record Updates

Last Update Posted (Actual)

June 18, 2018

Last Update Submitted That Met QC Criteria

June 15, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • P50AA010761-16 (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.

Clinical Trials on Trauma

Clinical Trials on Trier Social Stress Test (TSST)

Subscribe