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

• Sponsor: Prof. Dominique de Quervain, MD (Other)
• Overall Status: Completed
• CT.gov ID: NCT01718964
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 2
• Duration (Months): 8
• Patients Per Site Per Month: 3.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Opioid Dependence	Drug: Cortisol 20 mg; Drug: Mannitol	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Acute Effects of Cortisol on Heroin Craving in Opioid Dependence
• Study Start Date: Nov 1, 2012
• Actual Primary Completion Date: Jul 1, 2013
• Actual Study Completion Date: Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Other: A Cortisol 20 mg /Placebo Mannitol	Drug: Cortisol 20 mg; Drug: Mannitol; Mannitol used as placebo
Other: B Placebo Mannitol/Cortisol 20mg	Drug: Cortisol 20 mg; Drug: Mannitol; Mannitol used as placebo

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Psychiatric Hospital	Basel		Switzerland	4012

Sponsors and Collaborators

• Prof. Dominique de Quervain, MD

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Prof. Dominique de Quervain, MD, Professor MD, University of Basel
• ClinicalTrials.gov Identifier: NCT01718964
• Other Study ID Numbers: 2012DR2144
• First Posted: Nov 1, 2012
• Last Update Posted: Oct 30, 2013
• Last Verified: Oct 1, 2013

• Additional relevant MeSH terms: Opioid-Related Disorders; Hydrocortisone; Mannitol

Study Results

No Results Posted as of Oct 30, 2013