Effects of Glucocorticoids on Craving During Detoxification Treatment of Heroin and/or Stimulants (NCT02935101) | Clinical Trial Compass
TerminatedPhase 2
Effects of Glucocorticoids on Craving During Detoxification Treatment of Heroin and/or Stimulants
Stopped: difficulties in recruiting study participants
Switzerland4 participantsStarted 2016-10
Plain-language 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.
Who can participate
Age range18 Years – 99 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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: Anticoagul…
What they're measuring
1
Heroin Craving
Timeframe: Assessing change between baseline and some predefined time points during 2 weeks
2
Cocaine Craving
Timeframe: Assessing change between baseline and some predefined time points during 2 weeks
3
Heroin Craving
Timeframe: Assessing change between baseline and some predefined time points during 2 weeks
4
Cocaine Craving
Timeframe: Assessing change between baseline and some predefined time points during 2 weeks