Acute Effects of Cortisol on Alcohol Craving in Alcohol Dependence

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Inselspital, Berne
• Treatments: Cortisol succinate; Ethanol; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Mannitol

Criteria

Inclusion Criteria:

• Age ≥ 18

• Abstinent alcoholics in the 12-week in-patient program of the Clinic Südhang

• Abstained from alcohol for at least 6 weeks

• Voluntarily signed informed consent

Exclusion Criteria

• Co-morbid psychiatric disturbances (such as major depression, bipolar disorder, schizophrenia)

• Current medical conditions excluding participation (such as acute infectious disease)

• Recent history of systemic or topic glucocorticoid therapy

• Known hypersensitivity to the IMP under investigation (cortisol)

• Pregnancy, breast-feeding

• Inability to read and understand the participant's information

• Positive alcohol test according to breathalyser