TraumaARC5NCT01363180
Stress-induced Drinking in Emerging Adults: the Role of Trauma History
An observational study of Trauma and Posttraumatic Stress Disorder, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Trauma, Posttraumatic Stress Disorder
- What is being tested?
- Trier Social Stress Test (TSST) and No stress condition
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 197 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2011to 1 Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 21-30 year olds
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
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.
Read the 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.
- Conditions
- Trauma, Posttraumatic Stress Disorder
- Being tested
- Trier Social Stress Test (TSST), No stress condition
- Medical subject headings
- Wounds and Injuries, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trier Social Stress Test (TSST)Behavioural
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.
No stress conditionOther
| Study group | Role | What they receive |
|---|---|---|
| Control | Not described Receives: Behavioral: Trier Social Stress Test (TSST); Other: No stress condition | |
| Trauma-exposed without PTSD | Not described Receives: Behavioral: Trier Social Stress Test (TSST); Other: No stress condition | |
| Trauma-exposed with PTSD | Not described Receives: Behavioral: Trier Social Stress Test (TSST); Other: No stress condition |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2011 (estimated)
- Study start1 Jan 2011
- Primary completion31 Dec 2015
- Study completion1 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carla K Danielson, Ph.D., Principal investigator, Medical University of South CarolinaSuzanne Thomas, Ph.D., Study director, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01363180
- Sponsor's protocol ID
- P50AA010761-16
- Acronym
- ARC5
- Status last verified
- May 2018
- First submitted
- 27 May 2011
- Last updated
- 18 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress-induced Drinking in Emerging Adults: the Role of Trauma History
- ClinicalTrials.gov ID
- NCT01363180
- Acronym / sponsor ID
- ARC5 / P50AA010761-16
- Conditions
- Trauma, Posttraumatic Stress Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 1 Jun 2016 (actual)
- First posted
- 1 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | – | Behavioral: Trier Social Stress Test (TSST), Other: No stress condition |
| Trauma-exposed without PTSD | – | Behavioral: Trier Social Stress Test (TSST), Other: No stress condition |
| Trauma-exposed with PTSD | – | Behavioral: Trier Social Stress Test (TSST), Other: No stress condition |
Who may qualify
- Ages
- 21 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 21-30 year olds
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Control, Trauma-exposed with PTSD, Trauma-exposed without PTSD |
| No stress condition | Other | Control, Trauma-exposed with PTSD, Trauma-exposed without PTSD |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2018.
- MUSC Clinical Trials RegistryLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carla K Danielson, Ph.D. principal investigator
Medical University of South Carolina
Suzanne Thomas, Ph.D. study director
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma and Posttraumatic Stress Disorder, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2018.