Chronic Alcohol, Stress Inflammatory Response and Relapse Risk
United States116 participantsStarted 2011-09
Plain-language 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.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
cytokine levels
Timeframe: Day 1 and 2, (-25, -5, +5, +15, +30, +45)