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

Prof. Dominique de Quervain, MD30 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Opioid Dependence

Interventions

Cortisol 20 mgDRUG

MannitolDRUG

Mannitol used as placebo

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Psychiatric Hospital

Basel, Switzerland

Outcomes

Primary Outcomes

Heroin craving

outcome measures will be taken during the participants 2 test visit days. Each participant will stay for approx. 3 hours.

Time frame: baseline, change from baseline during and after presentation of drug stimuli

Secondary Outcomes

Anxiety

outcome measures will be taken during the participants 2 test visit days. Each participant will stay for approx. 3 hours.

Time frame: baseline, change from baseline during and after presentation of drug stimuli

Data from ClinicalTrials.gov

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