Effects of Glucocorticoids on Craving During Detoxification Treatment of Heroin and/or Stimulants

• Status: Terminated
• Trial end date: 2017-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate whether prednisolone lowers intensity and frequency of craving in heroin-addicted subjects undertaking a detoxification of cocaine and/or heroin.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Prof. Dominique de Quervain, MD
• Collaborator: Psychiatric Hospital of the University of Basel
• Treatments: Cocaine; Glucocorticoids; Heroin; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

• Informed Consent as documented by signature,

• age ≥18,

• Group A Detoxification of stimulants (cocaine, amphetamine and/or methamphetamine); ICD-10: F14.2 and/or F15.2) OR Stable opioid dependency (no parallel consumption). Detoxifica-tion of stimulants.

• Group B Opioid dependency and dependency of stimulants (cocaine, amphetamine and/or methamphetamine) and Detoxification of parallel consumption of stimulants and heroin (ICD-10: F11.2, 14.2, 15.2)

• admission for detoxification to ward U2 of the University Psychiatric Hospital of Basel

Exclusion Criteria:

• contraindications to the class of drugs under study or to any of the excipients, e.g. known hypersensitivity or allergy to class of drugs or the investigational product;

• acute or severe co-morbid psychiatric disturbances (such as a heavy episode of major depression with suicidal ideations, acute exacerbation of a bipolar disorder, acute exacerbation of schizophrenia, alcohol addiction with an acute relapse, psychosis, dementia);

• current medical conditions excluding participation (such as acute infectious disease, moni-tored by elevated CRP, diabetes mellitus, anticoagulation therapy);

• recent history of systemic or topic glucocorticoid therapy;

• alcohol intake > 0.0 ‰ according to breathalyser test on day 0 (screening) to exclude severe alcohol abuse;

• specific drugs not allowed during the study or for specific periods of time prior to the administration of the test dose: Anticoagulant agents, antidiabetic agents, cyclosporine;

• women who are pregnant or breast feeding;

• intention to become pregnant during the course of the study;

• inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia;

• participation in another study with investigational drug within the 30 days preceding or during the present study;

• previous enrolment into the current study;

• enrolment of the investigator, his/her family members, employees and other dependent persons.