NCT02196142

Brief Summary

To investigate the effects of cortisol on alcohol craving and stress reactivity in alcohol addicted subjects. Randomized, double-blind, placebo-controlled, cross-over, single administration of study medication. Study hypothesis: Cortisol has an inhibiting effect on alcohol craving and stress reactivity in alcohol dependent subjects.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2014

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 21, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

June 24, 2015

Status Verified

June 1, 2015

Enrollment Period

7 months

First QC Date

July 17, 2014

Last Update Submit

June 23, 2015

Conditions

Alcohol CravingPsychological StressPhysiological Stress

Keywords

CortisolAlcohol CravingAlcohol Dependence

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in alcohol craving score

    Measured by Alcohol Urge Questionnaire \& Visual Analogue Scale

    During and after presentation of drug stimuli, expected to be after 10 minutes

Secondary Outcomes (3)

  • Change from baseline in State-Trait-Anger Expression Inventory STAXI

    After presentation of drug stimuli, expected to be after 20 minutes

  • Change from baseline in heart rate variability

    During and after presentation of drug stimuli, expected to be after 10 minutes

  • Saliva Cortisol Level

    After presentation of drug stimuli, expected to be after 90 minutes

Study Arms (2)

Cortisol first, Placebo second

ACTIVE COMPARATOR

Drug: Cortisol 20mg, Drug: Mannitol (used as placebo)

Drug: Cortisol 20mgDrug: Placebo Mannitol

Placebo first, Cortisol second

ACTIVE COMPARATOR

Drug: Cortisol 20mg, Drug: Mannitol (used as placebo)

Drug: Cortisol 20mgDrug: Placebo Mannitol

Interventions

Cortisol 20mgDRUG

Drug: Cortisol 20mg

Cortisol first, Placebo secondPlacebo first, Cortisol second
Placebo MannitolDRUG

Drug: Placebo Mannitol

Cortisol first, Placebo secondPlacebo first, Cortisol second

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18
  • Abstinent alcoholics in the 12-week in-patient program of the Clinic Südhang
  • Abstained from alcohol for at least 6 weeks
  • Voluntarily signed informed consent

You may not qualify if:

  • Co-morbid psychiatric disturbances (such as major depression, bipolar disorder, schizophrenia)
  • Current medical conditions excluding participation (such as acute infectious disease)
  • Recent history of systemic or topic glucocorticoid therapy
  • Known hypersensitivity to the IMP under investigation (cortisol)
  • Pregnancy, breast-feeding
  • Inability to read and understand the participant's information
  • Positive alcohol test according to breathalyser

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinik Südhang

Kirchlindach, Canton of Bern, CH-3038, Switzerland

Location

MeSH Terms

Conditions

Stress, PsychologicalAlcoholism

Interventions

Hydrocortisone

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds11-HydroxycorticosteroidsHydroxycorticosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists17-Hydroxycorticosteroids

Study Officials

  • Leila Soravia, Dr. phil.

    University Hospital of Psychiatry Bern

    STUDY DIRECTOR

  • Peter Allemann, Dr. med.

    Clinic Südhang

    PRINCIPAL INVESTIGATOR

  • Dominique de Quervain, Prof. Dr.

    University Hospital, Basel, Switzerland

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2014

First Posted

July 21, 2014

Study Start

November 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

June 24, 2015

Record last verified: 2015-06

Locations

CH(1)