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Completed

NCT Number: NCT01718964

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

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.

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Key information

Conditions

Opioid Dependence Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Psychiatric Hospital

Basel, 4012, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cortisol 20 mg

Drug

Mannitol

Drug

Mannitol used as placebo

Primary outcomes

  1. Heroin craving

    Time frame: 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 outcomes

  1. Anxiety

    Time frame: 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 outcomes

  1. Symptoms of withdrawal

    Time frame: 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.

  2. saliva cortisol level

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Prof. Dominique de Quervain, MD

Other

Registry information

Official study title

Acute Effects of Cortisol on Heroin Craving in Opioid Dependence

Acronym: Ghost-Basel

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 1, 2012
Registry last updated
Oct 30, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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