Clinical trial NCT02935101: Effects of Glucocorticoids on Craving During Detoxification Treatment of Heroin and/or Stimulants
Official title: Effects of Glucocorticoids on Craving During Detoxification Treatment of Heroin and/or Stimulants
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Opioid Dependence
Cocaine Dependence
Keywords: glucocorticoids
craving
Heroin
Cocaine
dependency
Lead sponsor: University of Basel
Sponsor class: OTHER
Collaborators: name: Psychiatric Hospital of the University of Basel
First posted: 2016-10-17
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Heroin Craving
timeFrame: Assessing change between baseline and some predefined time points during 2 weeks
measure: Cocaine Craving
timeFrame: Assessing change between baseline and some predefined time points during 2 weeks
measure: Heroin Craving
timeFrame: Assessing change between baseline and some predefined time points during 2 weeks
measure: Cocaine Craving
timeFrame: Assessing change between baseline and some predefined time points during 2 weeks
Secondary outcomes:
measure: Withdrawal Symptoms according to ICD-10 (F14.3 and F12.2)
timeFrame: Assessing change between baseline and some predefined time points during 2 weeks
measure: Questionnaire 'Health State'
timeFrame: Assessing change between baseline and some predefined time points during 2 weeks
measure: Questionnaire 'Anger/Irritation'
timeFrame: Assessing change between baseline and some predefined time points during 2 weeks
measure: Questionnaire 'Anxiety'
timeFrame: Assessing change between baseline and some predefined time points during 2 weeks
measure: Saliva Cortisol levels
timeFrame: Assessing change between baseline and some predefined time points during 2 weeks
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Psychiatric Hospital University of Basel
Study officials:
affiliation: UPK Basel
name: Antje Kemter, MD
role: PRINCIPAL_INVESTIGATOR
References: