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

Acute Effects of Cortisol on Heroin Craving in Opioid Dependence

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01718964

Acronym

Ghost-Basel

Enrollment

Registered

2012-11-01

Start date

2012-11-30

Completion date

2013-07-31

Last updated

2013-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Dependence

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.

Interventions

DRUGCortisol 20 mg

DRUGMannitol

Mannitol used as placebo

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Other

Measure	Time frame	Description
Symptoms of withdrawal	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.
saliva cortisol level	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.

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026