Clinical Trials Logo

Clinical Trial Summary

To investigate the effects of cortisol on alcohol craving and stress reactivity in alcohol addicted subjects.

Randomized, double-blind, placebo-controlled, cross-over, single administration of study medication.

Study hypothesis: Cortisol has an inhibiting effect on alcohol craving and stress reactivity in alcohol dependent subjects.


Clinical Trial Description

Background

Alcohol dependence is a chronically and relapsing disorder with major impact on the persons psychological, physiological and social functioning. There is extensive evidence from animal and human studies pointing out the important role of addiction memory in the development and maintenance of the disorder.

Cognitive behavioural therapy (CBT) has proven its high effectiveness in the treatment for addictive disorders. A core element of CBT are exposure techniques that are comparable to extinction and habituation learning. The repeated exposure to alcohol related cues in the absence of alcohol ingestion will lead to extinction of conditioned responses, thus reducing the probability of relapse to alcohol taking behaviour.

Studies have shown that glucocorticoids impair memory retrieval in healthy subjects. In fact, the investigators could show that cortisol has a fear reducing effect in patients with post-traumatic stress disorder and in phobic patients, resulting particularly in reduced symptoms of anxiety and in reduced stress reactivity. Interestingly enough, pharmacologically induced high levels of glucocorticoids lowered the subjective feeling of anxiety and stress in situations activating per se the HPA-axis. Further it has been shown that the combined therapy of glucocorticoid administration and exposition based psychotherapy leads to better therapy outcome in patients with specific phobias.

Objective

The goal of this study is to examine the acute effects of glucocorticoids administration on alcohol craving and stress reactivity of abstinent alcohol dependent patients. On the basis of clinical research in anxiety disorders, the investigators expect that a pharmacologically increased cortisol level may impair the retrieval of addiction memory, which is indicated by less craving during the alcohol exposition, while exposition therapy enhances consolidation of corrective experiences. Similar to the research in anxiety patients, the investigators aim to examine whether cortisol administration could help improve the effects of exposition therapy in patients with alcohol dependence. The purpose is to decrease therapy duration through cortisol administration in addition to already well proven therapies and make the therapy more efficient as well as a factor in reducing healthcare costs.

Methods

Patients undergo two identical experimental sessions between the 6th and 8th week (one week in between) of their 12-week inpatient treatment program for alcohol dependence. The experiment takes place in the experimental rooms of the clinic Südhang between 1 and 6 pm. One hour before the confrontation with alcohol associated stimuli patients receive either 20mg of hydrocortisone or placebo (oral administration). The experiment consists of a computer based picture task (alcoholic and neutral pictures) and an in-vivo exposure task. Psychological (craving, stress, arousal) and physiological (heart rate, saliva cortisol) parameters are repeatedly measured over the course of the experiment. ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02196142
Study type Interventional
Source University Hospital Inselspital, Berne
Contact
Status Completed
Phase Phase 3
Start date November 2014
Completion date June 2015

See also
  Status Clinical Trial Phase
Recruiting NCT04680611 - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Completed NCT05703087 - Positive Cueing in Knee Arthroplasty. N/A
Completed NCT02541240 - Effects of an Intervention to Enhance Resilience in Physical Therapy Students N/A
Completed NCT02629016 - Stress Reduction: A Pilot Study With Adolescents N/A
Completed NCT01406028 - Does Emotional Support Decrease In Vitro Fertilization Stress? N/A
Completed NCT00121160 - Health SMART (Stress Management and Relaxation Training) to Improve Vaccine Immune Response Phase 1
Completed NCT02621775 - Effectiveness of Two Stress Management Programs in Adaptation Disorder With Anxiety (ADA) N/A
Recruiting NCT04474418 - Psychometric Characterization of Patients With Cardiac Arrhythmias
Completed NCT03310112 - Mindfulness Training in U.S. Army Cohorts N/A
Terminated NCT03893617 - Brief Stresses Experimental Study Phase 1
Active, not recruiting NCT05542498 - Promoting Stress Management and Engagement in Introductory Physics Courses With Mindfulness and Relaxation N/A
Completed NCT02394899 - Improving Parental Psychosocial Functioning and Early Developmental Outcomes in Children With Sickle Cell Disease N/A
Terminated NCT00962273 - The Pandemic Stress Vaccine: A Resource to Enhance the Resilience of Healthcare Workers Facing an Infectious Outbreak N/A
Completed NCT00451126 - Moderating Impact of Various Emotion Personality Factors on Salivary Cortisol Response to a TSST N/A
Completed NCT06051500 - Psychological and Physiological Effects of Different Objects of Breath Meditation N/A
Completed NCT02801045 - Art Therapy in Palliative Care: Study of Identification and Understanding of the Mechanisms of Change in the Patient N/A
Completed NCT03308344 - Mindfulness Training in Military Spouses N/A
Recruiting NCT06029348 - Cerebrovascular Health and Resilience in Midlife N/A
Completed NCT04484649 - Sleeping Healthy/Living Healthy Development N/A
Completed NCT05869006 - The Effect of Designed SIA Instrument Supported Interpersonal Relations-Based Group Practice on Psychological Well-Being and Creativity N/A