CClinicalTrials.gg
CompletedNCT00744588Updated Jan 3, 2013

Stress, Hypothalamic-pituitary-adrenal (HPA) Dysfunction, and Relapse in Alcoholism

An observational study in Alcohol Dependence, sponsored by University of Texas Southwestern Medical Center. Completed at 1 site in United States. Open to male participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2013-01-03.

Sponsored by University of Texas Southwestern Medical Center · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
75
Ages
18 Years to 60 Years
Sex
Male
01

Study summary

This proposal is part of the INIA Stress Consortium. This study will

  1. explore the contributions of lifetime trauma, recent stress, and alcohol use on stress-hormone axis disruption in treatment seeking, one-month abstinent, alcohol-dependent subjects
  2. assess the combined contributions of stress-hormone axis disruption and episodic stress on the risk of prospective drinking following treatment
  3. determine the role of neurosteroids in alcohol use.
Read the detailed description

The hypothalamic-pituitary-adrenal (HPA) system is suggested as a key biologic link in stress-induced relapse. The HPA axis provides a regulatory feedback network between the brain and the body's behavioral and physiologic responses to stress, recovery, and adaptation. Both trauma and chronic alcohol use produce persistent disturbances in the HPA response to stress. The chronic use of alcohol may also impair the stress-induced release of neurosteroids, compounds that directly modulate central nervous system activity. Thus, altered cortisol and neurosteroid responsiveness during abstinence may impair the central nervous system's ability to mount an appropriate response to environmental stressors, heightening the probability of relapse. However, the relationship between stress, relapse, and HPA axis disturbances remains tentative. In the proposed study, the investigators will assess the contribution of trauma, stress, and alcohol use upon pituitary-adrenocortical functioning in alcohol dependence. The relative contribution of adrenocortical disruption and episodic stress to prospective drinking behaviors will then be determined.

Hypothesis: We hypothesize (1) that lifetime trauma, recent stress, and chronic alcohol use will additively contribute to HPA axis disruption, (2) alterations in glucocorticoid and neurosteroid release as well as episodic stress will predict a return to drinking.

Methods: One hundred treatment-seeking, one-month abstinent, alcohol-dependent subjects will be studied. Standardized assessments will be used to assess childhood and adult trauma as well as recent (six months) stress. Pituitary-adrenal (including ACTH (adrenocorticotropin), cortisol, and neurosteroids) responses to both neuroendocrine [ovine corticotropin releasing hormone (oCRH), cosyntropin, and dexamethasone] and experiential (public speaking) challenges will be measured. Drinking behavior and episodic stress will be prospectively assessed for six months following neuroendocrine assessment.

Significance: If our hypotheses are supported, a definitive connection between previous trauma, biological stress response mechanisms, and ongoing stress upon prospective drinking behavior will be demonstrated. The identification of a specific biologic mechanism that underlies this association will provide a fertile framework for the development of targeted pharmacological interventions to decrease relapse in this vulnerable population. In addition, elucidating the concurrent contributions of stress-response biologic systems and externals stressors will provide the therapist and patient with a constellation of specific risk factors for focused treatment.

02

Conditions studied

  • Alcohol Dependence

Keywords

  • substance abuse
  • alcohol dependence
  • hypothalamic-pituitary-adrenal (HPA) system
  • cosyntropin
  • corticotropin-releasing Hormone (CRH)
  • pituitary-adrenal system
  • stress
  • trauma
  • neurosteroids
  • cortisol
  • relapse
03

In context

Recurrence

4,279 studies on the registry are indexed under Recurrence; 988 are open to participants now.

This study's enrollment of 75 is below the median of 200 across 702 observational studies indexed under Recurrence.

Browse Recurrence studies →

Lead sponsor

University of Texas Southwestern Medical Center is the lead sponsor of 990 studies on the registry; 201 are open to participants now.

Of its 135 completed or terminated interventional studies of FDA-regulated products, 100 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Inpatient treatment facility for substance use disorders.

Inclusion criteria

  • Diagnosis of alcohol dependence

Exclusion criteria

Exclusion Criteria:

  • Medical or psychiatric disorders that may effect stress-hormone axis functioning.
  • Medications that may effect stress-hormone axis functioning.
  • English speaking.
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
75 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • alcohol dependence

    Alcohol-dependent subjects currently being treated in an inpatient treatment facility.

06

What researchers measure

Primary outcomes

  1. Examine the contributions of previous trauma, recent stress, and chronic alcohol use to the stress-hormone axis reactivity in one-month abstinent alcohol-dependent subjects.

    Time frame: one month

Secondary outcomes

  1. Assess the ability of stress-hormone axis reactivity and ongoing stress to predict subsequent drinking behavior following treatment discharge.

    Time frame: Six months

07

Study locations

1 site
  • UT Southwestern Medical Center at Dallas
    Dallas, Texas 75390-8564, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 3, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00744588
Lead sponsor
University of Texas Southwestern Medical Center
Collaborators
Dallas VA Medical Center, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Responsible party
Bryon H Adinoff (Professor, University of Texas Southwestern Medical Center) — Principal investigator
First posted
Sep 1, 2008
Start date
Aug 2007
Primary completion
Aug 2011
Completion
Mar 2012
Last update
Jan 3, 2013

Study contacts

Bryon Adinoff, MD
principal investigator · UT Southwestern Medical Center at Dallas and VA North Texas Health Care System

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion