Acute Effects of Cortisol on Heroin Craving in Opioid Dependence
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Heroin craving
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Arms & Interventions
A
Cortisol 20 mg /Placebo Mannitol
Intervention: Cortisol 20 mg (Drug)
A
Cortisol 20 mg /Placebo Mannitol
Intervention: Mannitol (Drug)
B
Placebo Mannitol/Cortisol 20mg
Intervention: Cortisol 20 mg (Drug)
B
Placebo Mannitol/Cortisol 20mg
Intervention: Mannitol (Drug)
Outcomes
Primary Outcomes
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
- Anxiety(baseline, change from baseline during and after presentation of drug stimuli)
Investigators
Prof. Dominique de Quervain, MD
Professor MD
University of Basel