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

This study is currently recruiting participants.
Verified November 2012 by University of Basel
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: November 5, 2012
Last verified: November 2012
History of Changes
  Purpose

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 Intervention Phase
Opioid Dependence
 Drug: Cortisol 20 mg
Drug: Mannitol
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Acute Effects of Cortisol on Heroin Craving in Opioid Dependence

Resource links provided by NLM:

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Further study details as provided by University of Basel:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Estimated Enrollment: 30
Study Start Date: November 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01718964

Contacts
Contact: Dominique de Quervain, Prof. MD +41 61 ext 267 0237 dominique.dequervain@unibas.ch
Contact: Marc Walter, PD MD +41 61 ext 325 5036 marc.walter@upkbs.ch

Locations
Switzerland
Psychiatric Hospital Recruiting
Basel, Switzerland, 4012
Contact: Marc Walter, PD MD         marc.walter@upkbs.ch    
Principal Investigator: Marc Walter, PD MD            
Sponsors and Collaborators
Prof. Dominique de Quervain, MD
  More Information

No publications provided

Responsible Party: Prof. Dominique de Quervain, MD, Professor MD, University of Basel
ClinicalTrials.gov Identifier: NCT01718964     History of Changes
Other Study ID Numbers: 2012DR2144
Study First Received: October 23, 2012
Last Updated: November 5, 2012
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone
Hydrocortisone-17-butyrate
Mannitol
Analgesics, Opioid
Anti-Inflammatory Agents
Therapeutic Uses
 Pharmacologic Actions
Dermatologic Agents
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Cardiovascular Agents
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Central Nervous System Depressants

ClinicalTrials.gov processed this record on May 16, 2013