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

Phase 2TerminatedNCT02935101

Prof. Dominique de Quervain, MD4 enrolled

Overview

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.

Participants of this study are 120 heroin-addicted patients who are inward for a detoxification program for either cocaine or cocaine and heroin. Depending on the detoxification substance(s) there will be two groups of participants: Detoxification of cocaine (A; 60 participants) and detoxification of heroin and cocaine (B; 60 participants). The detoxification starts mandatory with the admission to the ward and lasts about 1-2 weeks. The participation in the study lasts about 4-5 weeks (including follow-up visits). Intake of study medication starts two days after admission and one day after informed consent. Each participant will get either 30mg/d prednisolon or placebo during five days. Participants will be under normal medical supervision during the treatment phase until follow-up 2 (final examination) provided by ward staff. Treatment days and follow-up 1 and 2 consist of : (1) vital signs (BP, HR, temperature) as measured in the daily routine, (2) at midday: visual analogue scales asking about craving for heroin and cocaine at the moment, (3) afternoon: questionnaires to survey mainly the withdrawal symptoms and vegetative parameters.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Opioid Dependence Cocaine Dependence

Interventions

PrednisoloneDRUG

formulated for oral administration. encapsulated.

Placebo (for Prednisolone)DRUG

Sugar pill manufactured to mimic Prednisolon 10mg capsules

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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.

Locations (1)

Psychiatric Hospital University of Basel

Basel, Switzerland