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

October 29, 2013 updated by: Prof. Dominique de Quervain, MD

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4012
        • Psychiatric Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: A
Cortisol 20 mg /Placebo Mannitol
Drug: Cortisol 20 mg
Drug: Mannitol
Mannitol used as placebo
Other: B
Placebo Mannitol/Cortisol 20mg
Drug: Cortisol 20 mg
Drug: Mannitol
Mannitol used as placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, change from baseline during and after presentation of drug stimuli

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, change from baseline during and after presentation of drug stimuli

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, change from baseline during and after presentation of drug stimuli
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.
baseline, change from baseline during and after presentation of drug stimuli

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prof. Dominique de Quervain, MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

October 23, 2012

First Submitted That Met QC Criteria

October 29, 2012

First Posted (Estimate)

November 1, 2012

Study Record Updates

Last Update Posted (Estimate)

October 30, 2013

Last Update Submitted That Met QC Criteria

October 29, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012DR2144

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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