Acute Effects of Cortisol on Heroin Craving in Opioid Dependence (Ghost-Basel)
Ghost-Basel
1 other identifier
interventional
30
1 country
1
Brief 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 subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2012
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 23, 2012
CompletedFirst Posted
Study publicly available on registry
November 1, 2012
CompletedStudy Start
First participant enrolled
November 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedOctober 30, 2013
October 1, 2013
8 months
October 23, 2012
October 29, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Heroin craving
outcome measures will be taken during the participants 2 test visit days. Each participant will stay for approx. 3 hours.
baseline, change from baseline during and after presentation of drug stimuli
Secondary Outcomes (1)
Anxiety
baseline, change from baseline during and after presentation of drug stimuli
Other Outcomes (2)
Symptoms of withdrawal
baseline, change from baseline during and after presentation of drug stimuli
saliva cortisol level
baseline, change from baseline during and after presentation of drug stimuli
Study Arms (2)
A
OTHERCortisol 20 mg /Placebo Mannitol
B
OTHERPlacebo Mannitol/Cortisol 20mg
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Psychiatric Hospital
Basel, 4012, Switzerland
Related Publications (1)
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.
PMID: 26218852DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor MD
Study Record Dates
First Submitted
October 23, 2012
First Posted
November 1, 2012
Study Start
November 1, 2012
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
October 30, 2013
Record last verified: 2013-10