Opioid DependencePhase 2Ghost-BaselNCT01718964
Acute Effects of Cortisol on Heroin Craving in Opioid Dependence (Ghost-Basel)
A Phase 2 study testing Cortisol 20 mg and Mannitol in people with Opioid Dependence, run by Prof. Dominique de Quervain, MD at 1 site in Switzerland.
Trial summary
To investigate the effects of cortisol on heroin craving and stress reaction in heroin addicted subjects Randomized, double-blind, placebo-controlled, cross-over, single administration of study medication Study hypothesis:Cortisol has an inhibiting effect on heroin craving and stress reactivity in opioid dependent… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Dependence
- What is being tested?
- Cortisol 20 mg and Mannitol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2012to Jul 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18
- Opioid dependency
- Participant in the Janus heroin programme of the UPK Basel
- Able to control parallel consumption of other drugs
- Stable i.v. substitution for at least 3 months
Who cannot join
- co-morbid psychiatric disturbances
- Current medical conditions excluding participation
- Recent history of systemic or topic glucocorticoid therapy
- known hypersensitivity to the IMP under investigation (cor-tisol)
- pregnancy, breast-feeding
- inability to read and understand the participant's information
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Effects of Cortisol on Heroin Craving in Opioid Dependence
To investigate the effects of cortisol on heroin craving and stress reaction in heroin addicted subjects Randomized, double-blind, placebo-controlled, cross-over, single administration of study medication Study hypothesis:Cortisol has an inhibiting effect on heroin craving and stress reactivity in opioid dependent subjects.
- Conditions
- Opioid Dependence
- Being tested
- Cortisol 20 mg, Mannitol
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cortisol 20 mgDrug
MannitolDrug
Mannitol used as placebo
| Study group | Role | What they receive |
|---|---|---|
| A | Other | Cortisol 20 mg /Placebo Mannitol Receives: Drug: Cortisol 20 mg; Drug: Mannitol |
| B | Other | Placebo Mannitol/Cortisol 20mg Receives: Drug: Cortisol 20 mg; Drug: Mannitol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heroin craving
outcome measures will be taken during the participants 2 test visit days. Each participant will stay for approx. 3 hours.
Measured: baseline, change from baseline during and after presentation of drug stimuli
Secondary outcomes (1)
Anxiety
outcome measures will be taken during the participants 2 test visit days. Each participant will stay for approx. 3 hours.
Measured: baseline, change from baseline during and after presentation of drug stimuli
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Prof. Dominique de Quervain, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Prof. Dominique de Quervain, MD, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01718964
- Sponsor's protocol ID
- 2012DR2144
- Acronym
- Ghost-Basel
- Status last verified
- Oct 2013
- First submitted
- 23 Oct 2012
- Last updated
- 30 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Walter M, Bentz D, Schicktanz N, Milnik A, Aerni A, Gerhards C, Schwegler K, Vogel M, Blum J, Schmid O, Roozendaal B, Lang UE, Borgwardt S, de Quervain D. Effects of cortisol administration on craving in heroin addicts. Transl Psychiatry. 2015 Jul 28;5(7):e610. doi: 10.1038/tp.2015.101.
PubMed 26218852
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Cortisol on Heroin Craving in Opioid Dependence
- ClinicalTrials.gov ID
- NCT01718964
- Acronym / sponsor ID
- Ghost-Basel / 2012DR2144
- Conditions
- Opioid Dependence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Prof. Dominique de Quervain, MDUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 1 Nov 2012 (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.
To investigate the effects of cortisol on heroin craving and stress reaction in heroin addicted subjects Randomized, double-blind, placebo-controlled, cross-over, single administration of study medication Study hypothesis:Cortisol has an inhibiting effect on heroin craving and stress reactivity in opioid dependent subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Other | Drug: Cortisol 20 mg, Drug: MannitolCortisol 20 mg /Placebo Mannitol |
| B | Other | Drug: Cortisol 20 mg, Drug: MannitolPlacebo Mannitol/Cortisol 20mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18
- Opioid dependency
- Participant in the Janus heroin programme of the UPK Basel
- Able to control parallel consumption of other drugs
- Stable i.v. substitution for at least 3 months
Key exclusion criteria (6 listed)
- co-morbid psychiatric disturbances
- Current medical conditions excluding participation
- Recent history of systemic or topic glucocorticoid therapy
- known hypersensitivity to the IMP under investigation (cor-tisol)
- pregnancy, breast-feeding
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 |
|---|---|---|
| Cortisol 20 mg | Drug | A, B |
| MannitolMannitol used as placebo | Drug | A, B |
Primary outcome
Heroin craving
Time frame: baseline, change from baseline during and after presentation of drug stimuli
outcome measures will be taken during the participants 2 test visit days. Each participant will stay for approx. 3 hours.
1 secondary outcome
Anxiety
Time frame: baseline, change from baseline during and after presentation of drug stimuli
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2013.
- Derived from this study: PubMed 26218852Walter M, Bentz D, Schicktanz N, Milnik A, Aerni A, Gerhards C, Schwegler K, Vogel M, Blum J, Schmid O, Roozendaal B, Lang UE, Borgwardt S, de Quervain D. Effects of cortisol administration on craving in heroin addicts. Transl Psychiatry. 2015 Jul 28;5(7):e610. doi: 10.1038/tp.2015.101.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cortisol 20 mg and Mannitol in people with Opioid 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 6 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: finished, as of the sponsor's last update on 30 Oct 2013. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: baseline, change from baseline during and after presentation of drug stimuli). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01718964, which also lists 1 linked publication.
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 30 Oct 2013.