Clinical trial NCT01363180: Stress-induced Drinking in Emerging Adults: the Role of Trauma History
Official title: Stress-induced Drinking in Emerging Adults: the Role of Trauma History
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trauma
Posttraumatic Stress Disorder
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2011-06-01
Enrollment: 197
Sex: ALL
Minimum age (years): 21
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 21-30 year olds

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.

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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Carla K Danielson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of South Carolina
name: Suzanne Thomas, Ph.D.
role: STUDY_DIRECTOR
References: