NCT02935101

Effects of Glucocorticoids on Craving During Detoxification Treatment of Heroin and/or Stimulants

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Prof. Dominique de Quervain, MD · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate whether prednisolone lowers intensity and frequency of craving in heroin-addicted subjects undertaking a detoxification of cocaine and/or heroin.

Detailed description

Participants of this study are 120 heroin-addicted patients who are inward for a detoxification program for either cocaine or cocaine and heroin. Depending on the detoxification substance(s) there will be two groups of participants: Detoxification of cocaine (A; 60 participants) and detoxification of heroin and cocaine (B; 60 participants). The detoxification starts mandatory with the admission to the ward and lasts about 1-2 weeks. The participation in the study lasts about 4-5 weeks (including follow-up visits). Intake of study medication starts two days after admission and one day after informed consent. Each participant will get either 30mg/d prednisolon or placebo during five days. Participants will be under normal medical supervision during the treatment phase until follow-up 2 (final examination) provided by ward staff. Treatment days and follow-up 1 and 2 consist of : (1) vital signs (BP, HR, temperature) as measured in the daily routine, (2) at midday: visual analogue scales asking about craving for heroin and cocaine at the moment, (3) afternoon: questionnaires to survey mainly the withdrawal symptoms and vegetative parameters.

Conditions

• Opioid Dependence
• Cocaine Dependence

Interventions

Type	Name	Description
DRUG	Prednisolone	formulated for oral administration. encapsulated.
DRUG	Placebo (for Prednisolone)	Sugar pill manufactured to mimic Prednisolon 10mg capsules

Timeline

• Start date: 2016-10-01
• Primary completion: 2017-05-01
• Completion: 2017-05-01
• First posted: 2016-10-17
• Last updated: 2019-05-23

Locations

1 site across 1 country: Switzerland