Opioid DependencePhase 2GoliathNCT02935101
Effects of Glucocorticoids on Craving During Detoxification Treatment of Heroin and/or Stimulants
A Phase 2 study testing Prednisolone in people with Opioid Dependence and Cocaine Dependence, run by Prof. Dominique de Quervain, MD at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Opioid Dependence, Cocaine Dependence
- What is being tested?
- Prednisolone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2016to May 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Opioid Dependence, Cocaine Dependence
- Being tested
- Prednisolone, Placebo (for Prednisolone)
- Keywords
- glucocorticoids, craving, Heroin, Cocaine, dependency
- Medical subject headings
- Opioid-Related Disorders, Cocaine-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoloneDrug
Also called Prednisolon Streuli(R)
formulated for oral administration. encapsulated.
Placebo (for Prednisolone)Drug
Sugar pill manufactured to mimic Prednisolon 10mg capsules
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Prednisolone |
| Placebo | Placebo comparator | Identical looking capsules like the IMP containing placebo (without active component) for oral administration. Receives: Drug: Placebo (for Prednisolone) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heroin Craving
Heroin Craving Questionnaire, 14 items (HCQ; Tiffany et al., 1993 and Heinz et al., 2006)
Measured: 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)
Measured: Assessing change between baseline and some predefined time points during 2 weeks
Heroin Craving
Visual Analogue Scale Craving
Measured: Assessing change between baseline and some predefined time points during 2 weeks
Cocaine Craving
Visual Analogue Scale Craving
Measured: 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)
Measured: Assessing change between baseline and some predefined time points during 2 weeks
Questionnaire 'Health State'
SF-12 (Morfeld M. et al., 2011)
Measured: 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)
Measured: Assessing change between baseline and some predefined time points during 2 weeks
Questionnaire 'Anxiety'
STAXI (Schwenkmezger P. et al., 1992/2006)
Measured: Assessing change between baseline and some predefined time points during 2 weeks
Saliva Cortisol levels
Measured: Assessing change between baseline and some predefined time points during 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionMay 2017
- Study completionMay 2017
Why it stopped: difficulties in recruiting study participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dominique de Quervain, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Psychiatric Hospital of the University of Basel
- Responsible party
- Sponsor-investigator, Prof. Dominique de Quervain, MD, University of Basel
- Investigators
- Antje Kemter, MD, Principal investigator, UPK Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02935101
- Sponsor's protocol ID
- 2016-00851
- Other IDs
- 2016
- Acronym
- Goliath
- Status last verified
- May 2019
- First submitted
- 12 Oct 2016
- Last updated
- 23 May 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Glucocorticoids on Craving During Detoxification Treatment of Heroin and/or Stimulants
- ClinicalTrials.gov ID
- NCT02935101
- Acronym / sponsor ID
- Goliath / 2016-00851
- Conditions
- Opioid Dependence, Cocaine Dependence
- Keywords
- glucocorticoids, craving, Heroin, Cocaine, dependency
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulties in recruiting study participants
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Prof. Dominique de Quervain, MDUniversity, hospital or other
- Collaborators
- Psychiatric Hospital of the University of Basel
- Study start
- Oct 2016
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 17 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prednisolon | Experimental | Drug: PrednisoloneParticipants 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). |
| Placebo | Placebo comparator | Drug: Placebo (for Prednisolone)Identical looking capsules like the IMP containing placebo (without active component) for oral administration. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Informed Consent as documented by signature,
- age ≥18,
- admission for detoxification to ward U2 of the University Psychiatric Hospital of Basel
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrednisoloneAlso: Prednisolon Streuli(R)formulated for oral administration. encapsulated. | Drug | Prednisolon |
| Placebo (for Prednisolone)Sugar pill manufactured to mimic Prednisolon 10mg capsules | Drug | Placebo |
Primary outcome
Heroin Craving
Time frame: Assessing change between baseline and some predefined time points during 2 weeks
Heroin Craving Questionnaire, 14 items (HCQ; Tiffany et al., 1993 and Heinz et al., 2006)
Cocaine Craving
Time frame: Assessing change between baseline and some predefined time points during 2 weeks
Cocaine Craving Questionnaire, 14 items (CCQ; Tiffany et al., 1993 and Heinz et al., 2006)
Heroin Craving
Time frame: Assessing change between baseline and some predefined time points during 2 weeks
Visual Analogue Scale Craving
Cocaine Craving
Time frame: Assessing change between baseline and some predefined time points during 2 weeks
Visual Analogue Scale Craving
5 secondary outcomes
Withdrawal Symptoms according to ICD-10 (F14.3 and F12.2)
Time frame: Assessing change between baseline and some predefined time points during 2 weeks
Questionnaire 'Health State'
Time frame: Assessing change between baseline and some predefined time points during 2 weeks
Questionnaire 'Anger/Irritation'
Time frame: Assessing change between baseline and some predefined time points during 2 weeks
Questionnaire 'Anxiety'
Time frame: Assessing change between baseline and some predefined time points during 2 weeks
Saliva Cortisol levels
Time frame: Assessing change between baseline and some predefined time points during 2 weeks
Results and safety
The study was stopped early (reason given: difficulties in recruiting study participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antje Kemter, MD principal investigator
UPK Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prednisolone in people with Opioid Dependence and Cocaine Dependence, run by Prof. Dominique de Quervain, MD at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: difficulties in recruiting study participants). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heroin Craving (time frame: Assessing change between baseline and some predefined time points during 2 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2019; AzTrials last refreshed its copy on 8 Nov 2026.