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

Prof. Dominique de Quervain, MD

Status and phase: Completed; Phase 2

Conditions: Opioid Dependence

Treatments: Drug: Mannitol; Drug: Cortisol 20 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT01718964

2012DR2144

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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30 participants in 2 patient groups

A

Other group

Description:

Cortisol 20 mg /Placebo Mannitol

Treatment:

Drug: Cortisol 20 mg

Drug: Mannitol

B

Other group

Description:

Placebo Mannitol/Cortisol 20mg

Treatment:

Drug: Cortisol 20 mg

Drug: Mannitol