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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02935101
Other study ID # 2016-00851
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date October 2016
Est. completion date May 2017

Study information

Verified date May 2019
Source University of Basel
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 4
Est. completion date May 2017
Est. primary completion date May 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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 Design


Intervention

Drug:
Prednisolone
formulated for oral administration. encapsulated.
Placebo (for Prednisolone)
Sugar pill manufactured to mimic Prednisolon 10mg capsules

Locations

Country Name City State
Switzerland Psychiatric Hospital University of Basel Basel

Sponsors (2)

Lead Sponsor Collaborator
Prof. Dominique de Quervain, MD Psychiatric Hospital of the University of Basel

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary Heroin Craving Visual Analogue Scale Craving Assessing change between baseline and some predefined time points during 2 weeks
Primary Cocaine Craving Visual Analogue Scale Craving Assessing change between baseline and some predefined time points during 2 weeks
Secondary Withdrawal Symptoms according to ICD-10 (F14.3 and F12.2) Assessing change between baseline and some predefined time points during 2 weeks
Secondary Questionnaire 'Health State' SF-12 (Morfeld M. et al., 2011) Assessing change between baseline and some predefined time points during 2 weeks
Secondary 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
Secondary Questionnaire 'Anxiety' STAXI (Schwenkmezger P. et al., 1992/2006) Assessing change between baseline and some predefined time points during 2 weeks
Secondary Saliva Cortisol levels Assessing change between baseline and some predefined time points during 2 weeks
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