Status:

COMPLETED

Chronic Alcohol, Stress Inflammatory Response and Relapse Risk

Lead Sponsor:

Yale University

Conditions:

Alcohol Dependence

Depressive Symptomatology

Eligibility:

All Genders

18-50 years

Phase:

NA

Brief Summary

The purpose of this study is to examine potential stress and immune systems adaptations underlying craving and relapse vulnerability in alcohol dependent (AD) individuals and social drinkers (SDs) wit...

Eligibility Criteria

Inclusion

  • ADs: Male and females, aged 18-50 years, meeting current DSM-IV criteria for alcohol dependence consuming more than 25 drinks / week.
  • SDs: Male and females, aged 18-50 years. Must not meet either current or lifetime DSM-IV criteria for alcohol/drug abuse. They must have demonstrated weekly alcohol use over the past year but no more than 25 drinks / month with no occasion of binge drinking (5 or more drinks-men; 4 or more -women).
  • ADs and SDs must self-report depression ratings at levels to match one of the two following groups: a) a score of 20 or above in the Center for Epidemiologic Studies - Depression Scale (CES-D), or b) a score between 3 -20 on the CES-D
  • Weekly alcohol use as documented by positive urine toxicology screens (AD only).
  • Good health as verified by screening examinations and medical and screening
  • Able to read English and complete study evaluations.
  • All participants must voluntarily provide informed consent and sign the informed consent document.

Exclusion

  • Meeting current criteria for dependence on another psychoactive substance, excluding nicotine.
  • Having any current Axis I psychiatric disorders and requiring treatment/medication for these conditions.
  • Having significant underlying medical conditions requiring medication.
  • Women who are pregnant or nursing.

Key Trial Info

Start Date :

September 1 2011

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2015

Estimated Enrollment :

116 Patients enrolled

Trial Details

Trial ID

NCT02193204

Start Date

September 1 2011

End Date

July 1 2015

Last Update

March 6 2020

Active Locations (1)

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CT Mental Health Center

New Haven, Connecticut, United States, 06519