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

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.

Study Overview

• Status: Terminated
• Conditions: Opioid Dependence; Cocaine Dependence
• Intervention / Treatment: Drug: Prednisolone; Drug: Placebo (for Prednisolone)

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.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 2

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4000
    • Psychiatric Hospital University of Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Prednisolon; 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).	Drug: Prednisolone; formulated for oral administration. encapsulated.; Other Names: Prednisolon Streuli(R)
PLACEBO_COMPARATOR: Placebo; Identical looking capsules like the IMP containing placebo (without active component) for oral administration.	Drug: Placebo (for Prednisolone); Sugar pill manufactured to mimic Prednisolon 10mg capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heroin Craving	Heroin Craving Questionnaire, 14 items (HCQ; Tiffany et al., 1993 and Heinz et al., 2006)	Assessing change between baseline and some predefined time points during 2 weeks
Cocaine Craving	Cocaine Craving Questionnaire, 14 items (CCQ; Tiffany et al., 1993 and Heinz et al., 2006)	Assessing change between baseline and some predefined time points during 2 weeks
Heroin Craving	Visual Analogue Scale Craving	Assessing change between baseline and some predefined time points during 2 weeks
Cocaine Craving	Visual Analogue Scale Craving	Assessing change between baseline and some predefined time points during 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Withdrawal Symptoms according to ICD-10 (F14.3 and F12.2)		Assessing change between baseline and some predefined time points during 2 weeks
Questionnaire 'Health State'	SF-12 (Morfeld M. et al., 2011)	Assessing change between baseline and some predefined time points during 2 weeks
Questionnaire 'Anger/Irritation'	STAI-G form X1 (state; Laux L. et al., 1981)	Assessing change between baseline and some predefined time points during 2 weeks
Questionnaire 'Anxiety'	STAXI (Schwenkmezger P. et al., 1992/2006)	Assessing change between baseline and some predefined time points during 2 weeks
Saliva Cortisol levels		Assessing change between baseline and some predefined time points during 2 weeks

Collaborators and Investigators

• Sponsor: Prof. Dominique de Quervain, MD
• Collaborators: Psychiatric Hospital of the University of Basel
• Investigators: Principal Investigator: Antje Kemter, MD, UPK Basel

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (ACTUAL): May 1, 2017
• Study Completion (ACTUAL): May 1, 2017

Study Registration Dates

• First Submitted: October 12, 2016
• First Submitted That Met QC Criteria: October 13, 2016
• First Posted (ESTIMATE): October 17, 2016

Study Record Updates

• Last Update Posted (ACTUAL): May 23, 2019
• Last Update Submitted That Met QC Criteria: May 22, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: craving; Cocaine; glucocorticoids; Heroin; dependency
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders; Cocaine-Related Disorders; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
• Other Study ID Numbers: 2016-00851

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED