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

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ClinicalTrials.gov Identifier: NCT01718964
Recruitment Status : Completed
First Posted : November 1, 2012
Last Update Posted : October 30, 2013
Sponsor:
Information provided by (Responsible Party):
Prof. Dominique de Quervain, MD, University of Basel

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.

Condition or disease Intervention/treatment Phase
Opioid Dependence Drug: Cortisol 20 mg Drug: Mannitol Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acute Effects of Cortisol on Heroin Craving in Opioid Dependence
Study Start Date : November 2012
Primary Completion Date : July 2013
Study Completion Date : July 2013


Arm Intervention/treatment
A
Cortisol 20 mg /Placebo Mannitol
Drug: Cortisol 20 mg Drug: Mannitol
Mannitol used as placebo
B
Placebo Mannitol/Cortisol 20mg
Drug: Cortisol 20 mg Drug: Mannitol
Mannitol used as placebo



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Anxiety [ 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.


Other Outcome Measures:
  1. Symptoms of withdrawal [ 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.

  2. saliva cortisol level [ 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01718964


Locations
Switzerland
Psychiatric Hospital
Basel, Switzerland, 4012
Sponsors and Collaborators
Prof. Dominique de Quervain, MD

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Dominique de Quervain, MD, Professor MD, University of Basel
ClinicalTrials.gov Identifier: NCT01718964     History of Changes
Other Study ID Numbers: 2012DR2144
First Posted: November 1, 2012    Key Record Dates
Last Update Posted: October 30, 2013
Last Verified: October 2013

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Mannitol
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Cortisol succinate
Hydrocortisone
Heroin
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Analgesics
Sensory System Agents
Peripheral Nervous System Agents