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Chronic Alcohol, Stress Inflammatory Response and Relapse Risk

Primary Purpose

Alcohol Dependence, Depressive Symptomatology

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Personal Stress Imagery
Neutral Imagery
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Alcohol Dependence focused on measuring Alcohol dependence, Stress, Cytokines, Depressive Symptomatology

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • CT Mental Health Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Social Drinkers Depressive Symptoms

Social Drinkers No Depressive Symptoms

Alcohol Dependent, Non-Depressive

Alchohol Dependent Depressive Symptoms

Arm 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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).
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.
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.

Full Information

First Posted
July 15, 2014
Last Updated
March 4, 2020
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT02193204
Brief Title
Chronic Alcohol, Stress Inflammatory Response and Relapse Risk
Official Title
Chronic Alcohol, Stress Inflammatory Response and Relapse Risk
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Dependence, Depressive Symptomatology
Keywords
Alcohol dependence, Stress, Cytokines, Depressive Symptomatology

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Social Drinkers Depressive Symptoms
Arm Type
Experimental
Arm 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.
Arm Title
Social Drinkers No Depressive Symptoms
Arm Type
Experimental
Arm 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.
Arm Title
Alcohol Dependent, Non-Depressive
Arm Type
Experimental
Arm 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.
Arm Title
Alchohol Dependent Depressive Symptoms
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Personal Stress Imagery
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Neutral Imagery
Intervention Description
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.
Primary Outcome Measure Information:
Title
cytokine levels
Description
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.
Time Frame
Day 1 and 2, (-25, -5, +5, +15, +30, +45)
Secondary Outcome Measure Information:
Title
Alcohol Craving
Description
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).
Time Frame
Day 14, Day 30 and Day 90
Title
Anxiety and Negative Mood
Description
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.
Time Frame
Day 14, Day 30 and Day 90
Title
Alcohol Relapse
Description
Relapse will be defined as a dichotomous variable and any alcohol use during the ninety days post discharge will be coded as relapse.
Time Frame
14, 30 and 90 day follow-ups

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen Fox, PhD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
CT Mental Health Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States

12. IPD Sharing Statement

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Chronic Alcohol, Stress Inflammatory Response and Relapse Risk

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