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Effects of Glucocorticoids on Craving During Detoxification Treatment of Heroin and/or Stimulants | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

NCT02935101•Prof. Dominique de Quervain, MD

View on ClinicalTrials.gov

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.

Detailed Description

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.

Eligibility

Age

18 - 99 years

Sex

ALL

Healthy Volunteers

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;
+2 more criteria

Locations (1)

Psychiatric Hospital University of Basel

Basel, Switzerland

Key Dates

Start Date

October 1, 2016

Primary Completion Date

May 1, 2017

Completion Date

May 1, 2017

Last Updated

May 23, 2019

Enrollment

ACTUAL participants

Conditions

Opioid DependenceCocaine Dependence

Interventions

Prednisolone

DRUG

Placebo (for Prednisolone)

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 23, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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