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

Opioid Dependence Clinical Trial

— Ghost-Basel  

Official title:

Acute Effects of Cortisol on Heroin Craving in Opioid Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01718964
• Other study ID #: 2012DR2144
• Status: Completed
• Phase: Phase 2
• First received: October 23, 2012
• Last updated: October 29, 2013
• Start date: November 2012
• Est. completion date: July 2013

Study information

• Verified date: October 2013
• Source: University of Basel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Opioid Dependence
• Opioid-Related Disorders

Intervention

Drug:
• Cortisol 20 mg

• Mannitol
Mannitol used as placebo

Locations

Country	Name	City	State
Switzerland	Psychiatric Hospital	Basel

Sponsors (1)

Lead Sponsor	Collaborator
Prof. Dominique de Quervain, MD

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Symptoms of withdrawal	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	No
Other	saliva cortisol level	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	No
Primary	Heroin craving	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	No
Secondary	Anxiety	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	No