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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2011 by Medical University of South Carolina
Sponsor:
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01363180
First received: May 27, 2011
Last updated: November 15, 2012
Last verified: May 2011
  Purpose

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 Intervention
Trauma
Posttraumatic Stress Disorder
Behavioral: Trier Social Stress Test (TSST)
Other: No stress condition

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Stress-induced Drinking in Emerging Adults: the Role of Trauma History

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Estimated Enrollment: 240
Study Start Date: June 2011
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   21 Years to 30 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01363180

Contacts
Contact: Arden Lowndes, BA 8437921841 lowndesa@musc.edu
Contact: Danna Lewsky, BS 8437921841 lewsky@musc.edu

Locations
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Elizabeth McGuan    843-792-5550    mcguan@musc.edu   
Contact: Emily Hartwell    8437921841    hartwele@musc.edu   
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Carla Danielson, Ph.D. MUSC
Study Director: Suzanne Thomas, Ph.D. MUSC
Study Director: Sarah W Book, M.D. MUSC
Study Director: Patrick Randall, Ph.D. MUSC
  More Information

Additional Information:
No publications provided

Responsible Party: Carla Kmett Danielson, Ph.D., MUSC
ClinicalTrials.gov Identifier: NCT01363180     History of Changes
Other Study ID Numbers: P50AA010761-16
Study First Received: May 27, 2011
Last Updated: November 15, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Wounds and Injuries
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 28, 2014