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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Dominique de Quervain, MD, University of Basel
ClinicalTrials.gov Identifier:
NCT01718964
First received: October 23, 2012
Last updated: October 29, 2013
Last verified: October 2013

October 23, 2012
October 29, 2013
November 2012
July 2013   (final data collection date for primary outcome measure)
Heroin craving [ Time Frame: baseline, change from baseline during and after presentation of drug stimuli ] [ Designated as safety issue: No ]
outcome measures will be taken during the participants 2 test visit days. Each participant will stay for approx. 3 hours.
Same as current
Complete list of historical versions of study NCT01718964 on ClinicalTrials.gov Archive Site
Anxiety [ Time Frame: baseline, change from baseline during and after presentation of drug stimuli ] [ Designated as safety issue: No ]
outcome measures will be taken during the participants 2 test visit days. Each participant will stay for approx. 3 hours.
Same as current
  • Symptoms of withdrawal [ Time Frame: baseline, change from baseline during and after presentation of drug stimuli ] [ Designated as safety issue: No ]
    outcome measures will be taken during the participants 2 test visit days. Each participant will stay for approx. 3 hours.
  • saliva cortisol level [ Time Frame: baseline, change from baseline during and after presentation of drug stimuli ] [ Designated as safety issue: No ]
    outcome measures will be taken during the participants 2 test visit days. Each participant will stay for approx. 3 hours.
Same as current
 
Acute Effects of Cortisol on Heroin Craving in Opioid Dependence (Ghost-Basel)
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Opioid Dependence
  • Drug: Cortisol 20 mg
  • Drug: Mannitol
    Mannitol used as placebo
  • A
    Cortisol 20 mg /Placebo Mannitol
    Interventions:
    • Drug: Cortisol 20 mg
    • Drug: Mannitol
  • B
    Placebo Mannitol/Cortisol 20mg
    Interventions:
    • Drug: Cortisol 20 mg
    • Drug: Mannitol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
July 2013
July 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01718964
2012DR2144
Yes
Prof. Dominique de Quervain, MD, University of Basel
Prof. Dominique de Quervain, MD
Not Provided
Not Provided
University of Basel
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP