- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02193204
Chronic Alcohol, Stress Inflammatory Response and Relapse Risk
March 4, 2020 updated by: Yale University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
116
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Connecticut
-
New Haven, Connecticut, United States, 06519
- CT Mental Health Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Social Drinkers Depressive Symptoms
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.
|
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.
|
Experimental: Social Drinkers No Depressive Symptoms
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.
|
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.
|
Experimental: Alcohol Dependent, Non-Depressive
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.
|
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.
|
Experimental: Alchohol Dependent Depressive Symptoms
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
cytokine levels
Time Frame: Day 1 and 2, (-25, -5, +5, +15, +30, +45)
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alcohol Craving
Time Frame: Day 14, Day 30 and Day 90
|
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
|
Anxiety and Negative Mood
Time Frame: Day 14, Day 30 and Day 90
|
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
|
Alcohol Relapse
Time Frame: 14, 30 and 90 day follow-ups
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Helen Fox, PhD, Yale University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2011
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
July 15, 2014
First Submitted That Met QC Criteria
July 16, 2014
First Posted (Estimate)
July 17, 2014
Study Record Updates
Last Update Posted (Actual)
March 6, 2020
Last Update Submitted That Met QC Criteria
March 4, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1111009349
- 1R01AA02009501A (Other Identifier: Other Federal Funding)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Alcohol Dependence
-
University Hospital, LilleCompleted
-
Tel-Aviv Sourasky Medical CenterMinistry of Health, IsraelUnknownAlcohol-dependenceIsrael
-
Pop Test Oncology LLCBaylor College of Medicine; Michael E. DeBakey VA Medical Center; Congressionally... and other collaboratorsCompletedPotential Treatment for Alcohol Dependence-Alcohol InteractionUnited States
-
DynamiCare HealthNational Institute on Alcohol Abuse and Alcoholism (NIAAA); RANDActive, not recruitingAlcohol Dependence | Alcohol Use Disorder | Drug DependenceUnited States
-
National Institute on Alcohol Abuse and Alcoholism...CompletedAlcohol Abuse | Alcohol Dependence (Primary Condition)United States
-
University Hospital, Gentofte, CopenhagenCompleted
-
Massachusetts General HospitalCompletedAlcohol Dependence | Drug Abuse | Alcohol Abuse | Drug DependenceUnited States
-
Psychiatric Centre RigshospitaletThe Novavì outpatient clinics, CopenhagenRecruitingAddiction, Alcohol | Alcohol Dependence, in RemissionDenmark
-
University of WashingtonU.S. Army Medical Research and Development CommandCompletedAlcohol Dependence | Substance Abuse | Alcohol Abuse | Substance DependenceUnited States
-
Anders Fink-Jensen, MD, DMSciThe Novavì outpatient clinics, Copenhagen; Neurobiology Research Unit, Rigshospitalet... and other collaboratorsCompletedAddiction, Alcohol | Alcohol Dependence, in RemissionDenmark
Clinical Trials on Personal Stress Imagery
-
Yale UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedObesity | Food Craving | Food ConsumptionUnited States
-
University of CalgaryAlberta Health servicesCompleted
-
University of Southern CaliforniaCompletedObesity | Stress | Insulin ResistanceUnited States
-
University of Maryland, BaltimoreCompleted
-
Universiti Sains MalaysiaCompletedFunctional Gastrointestinal DisordersMalaysia
-
University of Massachusetts, AmherstCompleted
-
VA Office of Research and DevelopmentNew York University Grossman School of MedicineRecruitingHearing Loss | Hospital Readmission | Emergency ServiceUnited States
-
H. Lee Moffitt Cancer Center and Research InstituteAmerican Cancer Society, Inc.Completed
-
Hella JanssenCompletedPsychosis | Auditory Hallucination | Hearing Voices When No One is TalkingNetherlands
-
University of Illinois at ChicagoNational Institute of Mental Health (NIMH); Emory University; University of Mississippi... and other collaboratorsRecruitingMedication Adherence | Retention in CareUnited States