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

Phase 2

Completed

• Conditions: Opioid Dependence
• Interventions: Drug: Cortisol 20 mg; Drug: Mannitol

• Registration Number: NCT01718964
• Lead Sponsor: Prof. Dominique de Quervain, MD

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-10-23
• Study First Submitted QC: 2012-10-29
• Study Start: 2012-11
• Study First Posted: 2012-11-01
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-29
• Last Update Posted: 2013-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A	Cortisol 20 mg	Cortisol 20 mg /Placebo Mannitol
B	Cortisol 20 mg	Placebo Mannitol/Cortisol 20mg
A	Mannitol	Cortisol 20 mg /Placebo Mannitol
B	Mannitol	Placebo Mannitol/Cortisol 20mg

Primary Outcome Measures

Name	Time	Method
Heroin craving	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

Name	Time	Method
Anxiety	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.

Trial Locations

Locations (1)

Psychiatric Hospital; 🇨🇭 Basel, Switzerland