- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01363180
Stress-induced Drinking in Emerging Adults: the Role of Trauma History (ARC5)
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Control
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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.
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|
Trauma-exposed without PTSD
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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
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
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
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.
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