Stress-induced Drinking in Emerging Adults: the Role of Trauma History
ARC5
1 other identifier
observational
197
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2011
Longer than P75 for all trials
1 active site
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
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 27, 2011
CompletedFirst Posted
Study publicly available on registry
June 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedJune 18, 2018
May 1, 2018
5 years
May 27, 2011
June 15, 2018
Conditions
Study Arms (3)
Control
Trauma-exposed without PTSD
Trauma-exposed with PTSD
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.
Eligibility Criteria
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
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carla K Danielson, Ph.D.
Medical University of South Carolina
- STUDY DIRECTOR
Suzanne Thomas, Ph.D.
Medical University of South Carolina
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