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

NCT02935101 | Terminated Phase 2

• 1 other identifier: 2016-00851
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Dependence; Cocaine Dependence

Keywords

glucocorticoids; craving; Heroin; Cocaine; dependency

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• 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'

  Assessing change between baseline and some predefined time points during 2 weeks

• Questionnaire 'Anger/Irritation'

  Assessing change between baseline and some predefined time points during 2 weeks

• Questionnaire 'Anxiety'

  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

Study Arms (2)

Prednisolon

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo (for Prednisolone)

Interventions

Prednisolone DRUG

formulated for oral administration. encapsulated.

Also known as: Prednisolon Streuli(R)

Prednisolon

Placebo (for Prednisolone) DRUG

Sugar pill manufactured to mimic Prednisolon 10mg capsules

Placebo

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Prof. Dominique de Quervain, MD: lead
• Psychiatric Hospital of the University of Basel: collaborator

Study Sites (1)

Psychiatric Hospital University of Basel

Basel, 4000, Switzerland

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Cocaine-Related Disorders

Interventions

Prednisolone

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Antje Kemter, MD

  UPK Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director Division Cognitive Neuroscience

Study Record Dates

• First Submitted: October 12, 2016
• First Posted: October 17, 2016
• Study Start: October 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: May 23, 2019

Record last verified: 2019-05

Locations

CH (1)