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

NCT ID: NCT01718964

Last Updated: 2013-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-07-31

Brief Summary

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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

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Conditions

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Opioid Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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A

Cortisol 20 mg /Placebo Mannitol

Group Type OTHER

Cortisol 20 mg

Intervention Type DRUG

Mannitol

Intervention Type DRUG

Mannitol used as placebo

B

Placebo Mannitol/Cortisol 20mg

Group Type OTHER

Cortisol 20 mg

Intervention Type DRUG

Mannitol

Intervention Type DRUG

Mannitol used as placebo

Interventions

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Cortisol 20 mg

Intervention Type DRUG

Mannitol

Mannitol used as placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Prof. Dominique de Quervain, MD

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dominique de Quervain, MD

Professor MD

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Psychiatric Hospital

Basel, , Switzerland

Site Status

Countries

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Switzerland

References

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Walter M, Bentz D, Schicktanz N, Milnik A, Aerni A, Gerhards C, Schwegler K, Vogel M, Blum J, Schmid O, Roozendaal B, Lang UE, Borgwardt S, de Quervain D. Effects of cortisol administration on craving in heroin addicts. Transl Psychiatry. 2015 Jul 28;5(7):e610. doi: 10.1038/tp.2015.101.

Reference Type DERIVED
PMID: 26218852 (View on PubMed)

Other Identifiers

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2012DR2144

Identifier Type: -

Identifier Source: org_study_id