Chronic Alcohol, Stress Inflammatory Response and Relapse Risk

Yale University

Status: Completed

Conditions: Depressive Symptomatology; Alcohol Dependence

Treatments: Behavioral: Neutral Imagery; Behavioral: Personal Stress Imagery

Study type: Interventional

Funder types: Other

Identifiers

NCT02193204

1R01AA02009501A (Other Identifier)

1111009349

Details and patient eligibility

About

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.

Enrollment: 116 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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116 participants in 4 patient groups

Social Drinkers Depressive Symptoms

Experimental group

Description:

30 non-dependent light socially drinking (SD) smokers with depressive symptoms will be recruited to participate in two laboratory sessions (Stress and Neutral / Relaxing). This arm will be exposed to both the personal stress imagery and neutral imagery interventions.

Treatment:

Behavioral: Neutral Imagery

Behavioral: Personal Stress Imagery

Social Drinkers No Depressive Symptoms

Experimental group

Description:

30 non-dependent light socially drinking (SD) smokers without depressive symptoms will be recruited to participate in two laboratory sessions (Stress and Neutral / Relaxing). This arm will be exposed to both the personal stress imagery and neutral imagery interventions.

Treatment:

Behavioral: Neutral Imagery

Behavioral: Personal Stress Imagery

Alcohol Dependent, Non-Depressive

Experimental group

Description:

30 treatment-engaged 28-day abstinent, alcohol dependent (AD) smokers, without Depressive symptoms. All AD subjects will either be admitted to the Clinical Neuroscience Research Unit (CNRU) of the Connecticut Mental Health Center for five weeks of inpatient stay and study participation (inpatient), or they will be scheduled for a two night stay on the CNRU following 3 weeks of abstinence (outpatient). This arm will be exposed to both the personal stress imagery and neutral imagery interventions.

Treatment:

Behavioral: Neutral Imagery

Behavioral: Personal Stress Imagery

Alchohol Dependent Depressive Symptoms

Experimental group

Description:

30 treatment-engaged 28-day abstinent, alcohol dependent smokers with depressive symptoms. All AD subjects will either be admitted to the Clinical Neuroscience Research Unit (CNRU) of the Connecticut Mental Health Center for five weeks of inpatient stay and study participation (inpatient), or they will be scheduled for a two night stay on the CNRU following 3 weeks of abstinence (outpatient). This arm will be exposed to both the personal stress imagery and neutral imagery interventions.

Treatment:

Behavioral: Neutral Imagery

Behavioral: Personal Stress Imagery