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Acute Effects of Cortisol on Heroin Craving in Opioid Dependence (Ghost-Basel) (Ghost-Basel)

Primary Purpose

Opioid Dependence

Status
Completed
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
Cortisol 20 mg
Mannitol
Sponsored by
Prof. Dominique de Quervain, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Dependence

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Psychiatric Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

A

B

Arm Description

Cortisol 20 mg /Placebo Mannitol

Placebo Mannitol/Cortisol 20mg

Outcomes

Primary Outcome Measures

Heroin craving
outcome measures will be taken during the participants 2 test visit days. Each participant will stay for approx. 3 hours.

Secondary Outcome Measures

Anxiety
outcome measures will be taken during the participants 2 test visit days. Each participant will stay for approx. 3 hours.

Full Information

First Posted
October 23, 2012
Last Updated
October 29, 2013
Sponsor
Prof. Dominique de Quervain, MD
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1. Study Identification

Unique Protocol Identification Number
NCT01718964
Brief Title
Acute Effects of Cortisol on Heroin Craving in Opioid Dependence (Ghost-Basel)
Acronym
Ghost-Basel
Official Title
Acute Effects of Cortisol on Heroin Craving in Opioid Dependence
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Prof. Dominique de Quervain, MD

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Dependence

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Other
Arm Description
Cortisol 20 mg /Placebo Mannitol
Arm Title
B
Arm Type
Other
Arm Description
Placebo Mannitol/Cortisol 20mg
Intervention Type
Drug
Intervention Name(s)
Cortisol 20 mg
Intervention Type
Drug
Intervention Name(s)
Mannitol
Intervention Description
Mannitol used as placebo
Primary Outcome Measure Information:
Title
Heroin craving
Description
outcome measures will be taken during the participants 2 test visit days. Each participant will stay for approx. 3 hours.
Time Frame
baseline, change from baseline during and after presentation of drug stimuli
Secondary Outcome Measure Information:
Title
Anxiety
Description
outcome measures will be taken during the participants 2 test visit days. Each participant will stay for approx. 3 hours.
Time Frame
baseline, change from baseline during and after presentation of drug stimuli
Other Pre-specified Outcome Measures:
Title
Symptoms of withdrawal
Description
outcome measures will be taken during the participants 2 test visit days. Each participant will stay for approx. 3 hours.
Time Frame
baseline, change from baseline during and after presentation of drug stimuli
Title
saliva cortisol level
Description
outcome measures will be taken during the participants 2 test visit days. Each participant will stay for approx. 3 hours.
Time Frame
baseline, change from baseline during and after presentation of drug stimuli

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Psychiatric Hospital
City
Basel
ZIP/Postal Code
4012
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
26218852
Citation
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.
Results Reference
derived

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Acute Effects of Cortisol on Heroin Craving in Opioid Dependence (Ghost-Basel)

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