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

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ClinicalTrials.gov Identifier: NCT01363180
Recruitment Status : Completed
First Posted : June 1, 2011
Last Update Posted : June 18, 2018
Sponsor:
Information provided by (Responsible Party):
Medical University of South Carolina

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.

Condition or disease Intervention/treatment
Trauma Posttraumatic Stress Disorder Behavioral: Trier Social Stress Test (TSST) Other: No stress condition

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
Actual Enrollment : 197 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Stress-induced Drinking in Emerging Adults: the Role of Trauma History
Actual Study Start Date : January 1, 2011
Actual Primary Completion Date : December 31, 2015
Actual Study Completion Date : June 1, 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Control Behavioral: Trier Social Stress Test (TSST)
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.

Other: No stress condition
Trauma-exposed without PTSD Behavioral: Trier Social Stress Test (TSST)
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.

Other: No stress condition
Trauma-exposed with PTSD Behavioral: Trier Social Stress Test (TSST)
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.

Other: No stress condition




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Ages Eligible for Study:   21 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
21-30 year olds
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01363180


Locations
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Carla K Danielson, Ph.D. Medical University of South Carolina
Study Director: Suzanne Thomas, Ph.D. Medical University of South Carolina

Additional Information:
Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01363180     History of Changes
Other Study ID Numbers: P50AA010761-16 ( U.S. NIH Grant/Contract )
First Posted: June 1, 2011    Key Record Dates
Last Update Posted: June 18, 2018
Last Verified: May 2018

Additional relevant MeSH terms:
Wounds and Injuries
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders