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
  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:


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.


Enrollment: 30
Study Start Date: November 2012
Study Completion Date: July 2013
Primary Completion Date: July 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01718964

Locations
Switzerland
Psychiatric Hospital
Basel, Switzerland, 4012
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: October 29, 2013
Health Authority: Switzerland: Swissmedic

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

ClinicalTrials.gov processed this record on October 23, 2014