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

Primary Purpose

Opioid Dependence, Cocaine Dependence

Status

Terminated

Phase

Phase 2

Locations

Switzerland

Study Type

Interventional

Intervention

Prednisolone

Placebo (for Prednisolone)

About this trial

This is an interventional basic science trial for Opioid Dependence focused on measuring glucocorticoids, craving, Heroin, Cocaine, dependency

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept 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;
previous enrolment into the current study;
enrolment of the investigator, his/her family members, employees and other dependent persons.

Sites / Locations

Psychiatric Hospital University of Basel

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Prednisolon

Placebo

Arm Description

Participants will receive an oral administration of prednisolone or placebo two times daily for the first five days of opioid detoxification, starting after one day of regular detoxification as baseline. Oral prednisolone will be administered in a dose consistent with standard treatment guidelines for glucocorticoid deficiency (Oelkers, 1996).

Identical looking capsules like the IMP containing placebo (without active component) for oral administration.

Outcomes

Primary Outcome Measures

Heroin Craving

Heroin Craving Questionnaire, 14 items (HCQ; Tiffany et al., 1993 and Heinz et al., 2006)

Cocaine Craving

Cocaine Craving Questionnaire, 14 items (CCQ; Tiffany et al., 1993 and Heinz et al., 2006)

Heroin Craving

Visual Analogue Scale Craving

Cocaine Craving

Visual Analogue Scale Craving

Secondary Outcome Measures

Withdrawal Symptoms according to ICD-10 (F14.3 and F12.2)

Questionnaire 'Health State'

SF-12 (Morfeld M. et al., 2011)

Questionnaire 'Anger/Irritation'

STAI-G form X1 (state; Laux L. et al., 1981)

Questionnaire 'Anxiety'

STAXI (Schwenkmezger P. et al., 1992/2006)

Saliva Cortisol levels

Full Information

NCT ID

NCT02935101

First Posted

October 12, 2016

Last Updated

May 22, 2019

Sponsor

Prof. Dominique de Quervain, MD

Collaborators

Psychiatric Hospital of the University of Basel

1. Study Identification

Unique Protocol Identification Number

NCT02935101

Brief Title

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

Acronym

Goliath

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2019

Overall Recruitment Status

Terminated

Why Stopped

difficulties in recruiting study participants

Study Start Date

October 2016 (undefined)

Primary Completion Date

May 2017 (Actual)

Study Completion Date

May 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Prof. Dominique de Quervain, MD

Collaborators

Psychiatric Hospital of the University of Basel

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Opioid Dependence, Cocaine Dependence

Keywords

glucocorticoids, craving, Heroin, Cocaine, dependency

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Prednisolon

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Identical looking capsules like the IMP containing placebo (without active component) for oral administration.

Intervention Type

Drug

Intervention Name(s)

Prednisolone

Other Intervention Name(s)

Prednisolon Streuli(R)

Intervention Description

formulated for oral administration. encapsulated.

Intervention Type

Drug

Intervention Name(s)

Placebo (for Prednisolone)

Intervention Description

Sugar pill manufactured to mimic Prednisolon 10mg capsules

Primary Outcome Measure Information:

Title

Heroin Craving

Description

Heroin Craving Questionnaire, 14 items (HCQ; Tiffany et al., 1993 and Heinz et al., 2006)

Time Frame