Clinical trial NCT02193204: Chronic Alcohol, Stress Inflammatory Response and Relapse Risk
Official title: Chronic Alcohol, Stress Inflammatory Response and Relapse Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Dependence
Depressive Symptomatology
Keywords: Alcohol dependence
Stress
Cytokines
Depressive Symptomatology
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2014-07-17
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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) with and without high levels of depressive symptomatology (+dep / - dep). Using the investigators experimentally validated guided imagery procedure, the investigators propose to examine the response of brain stress and immune systems to personalized guided stressful imagery using subjective, physiological and neurobiological assessments in 60 healthy controls and 60 alcoholic dependent individuals with and without depressive symptomatology.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: cytokine levels
timeFrame: Day 1 and 2, (-25, -5, +5, +15, +30, +45)
Secondary outcomes:
measure: Alcohol Craving
timeFrame: Day 14, Day 30 and Day 90
measure: Anxiety and Negative Mood
timeFrame: Day 14, Day 30 and Day 90
measure: Alcohol Relapse
timeFrame: 14, 30 and 90 day follow-ups
Other outcomes:
Locations:
city: New Haven
country: United States
facility: CT Mental Health Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Helen Fox, PhD
role: PRINCIPAL_INVESTIGATOR
References: