Chronic Alcohol, Stress Inflammatory Response and Relapse Risk

Alcohol Dependence Clinical Trial

Official title:

Chronic Alcohol, Stress Inflammatory Response and Relapse Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02193204
• Other study ID #: 1111009349
• Secondary ID: 1R01AA02009501A
• Status: Completed
• Phase: N/A
• Start date: September 2011
• Est. completion date: July 2015

Study information

• Verified date: March 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Dependence
• Alcoholism
• Depressive Symptomatology

Intervention

Behavioral:
• Personal Stress Imagery
The stress imagery script will be based on participants' description of a recent personal event experienced as "most stressful", and determined as such by rating it above 8 on a 10-point stress scale. These may include breakup with a significant other or job-related stress. A 5-minute 'script' of each scenario will be written using Scene Construction Questionnaires where physiological, bodily sensations regarding the event will be obtained. Scripts will then be recorded onto audiotape for guided imagery in the laboratory sessions.
• Neutral Imagery
The neutral script will be developed from a personal non-alcohol-related relaxing situation. A 5-minute 'script' of each scenario will be written using Scene Construction Questionnaires where physiological, bodily sensations regarding the event will be obtained. Scripts will then be recorded onto audiotape for guided imagery in the laboratory sessions.

Locations

Country	Name	City	State
United States	CT Mental Health Center	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cytokine levels	At each of the six time-points (-25, -5, +5, +15, +30, +45), serum cytokine concentrations of IL-6, TNFa, TNFR1, IL-10, IL1-ra, IL-4, IL1beta, and IL-12 will be collected. Levels will be determined by enzyme-linked immuno-sorbent assays using the DuoSet ELISA Development Kit from R&D systems (Minneapolis, MN, USA). Plasma Cortisol and ACTH levels will also be colected and assays will be measured using standard radioimmunoassay procedures.	Day 1 and 2, (-25, -5, +5, +15, +30, +45)
Secondary	Alcohol Craving	Participants will rate their desire to have an alcoholic drink as well as how anxious they feel at that moment using a10-point visual analog scale (VAS).	Day 14, Day 30 and Day 90
Secondary	Anxiety and Negative Mood	Differential Emotion Scale - DES (Izard, 1972): Subjects are required to rate on a 5-point scale the extent to which an emotional word (item) describes the way s/he feels at the current time. Data is collapsed into subscales: anger, anxiety, fear, sadness, joy, and relaxed state.	Day 14, Day 30 and Day 90
Secondary	Alcohol Relapse	Relapse will be defined as a dichotomous variable and any alcohol use during the ninety days post discharge will be coded as relapse.	14, 30 and 90 day follow-ups