Chronic Alcohol, Stress Inflammatory Response and Relapse Risk
2 other identifiers
interventional
116
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2011
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 15, 2014
CompletedFirst Posted
Study publicly available on registry
July 17, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedMarch 6, 2020
March 1, 2020
3.8 years
July 15, 2014
March 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Alcohol Craving
Day 14, Day 30 and Day 90
Anxiety and Negative Mood
Day 14, Day 30 and Day 90
Alcohol Relapse
14, 30 and 90 day follow-ups
Study Arms (4)
Social Drinkers Depressive Symptoms
EXPERIMENTAL30 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.
Social Drinkers No Depressive Symptoms
EXPERIMENTAL30 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.
Alcohol Dependent, Non-Depressive
EXPERIMENTAL30 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.
Alchohol Dependent Depressive Symptoms
EXPERIMENTAL30 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.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
Study Sites (1)
CT Mental Health Center
New Haven, Connecticut, 06519, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Helen Fox, PhD
Yale University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 15, 2014
First Posted
July 17, 2014
Study Start
September 1, 2011
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
March 6, 2020
Record last verified: 2020-03