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The purpose of this study is to evaluate whether prednisolone lowers intensity and frequency of craving in heroin-addicted subjects undertaking a detoxification of parallel consumption of cocaine and/or heroin.
Participants of this study are 120 heroin-addicted patients who are inward for a detoxification program for parallel consumption of either cocaine or cocaine and heroin. Depending on the detoxification substance(s) there will be two groups of participants: Detoxification of parallel consumption of cocaine (A; 60 participants) and detoxification of parallel consumption 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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science
Prednisolone, Placebo (for Prednisolone)
Not yet recruiting
University of Basel
Published on BioPortfolio: 2016-10-18T02:08:21-0400
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A synthetic opioid that is used as the hydrochloride. It is an opioid analgesic that is primarily a mu-opioid agonist. It has actions and uses similar to those of MORPHINE. It also has a depressant action on the cough center and may be given to control intractable cough associated with terminal lung cancer. Methadone is also used as part of the treatment of dependence on opioid drugs, although prolonged use of methadone itself may result in dependence. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1082-3)
A PREDNISOLONE derivative with similar anti-inflammatory action.
A synthetic anti-inflammatory glucocorticoid derived from CORTISONE. It is biologically inert and converted to PREDNISOLONE in the liver.
A glucocorticoid with the general properties of the corticosteroids. It is the drug of choice for all conditions in which routine systemic corticosteroid therapy is indicated, except adrenal deficiency states.
Ester of CHLORAMBUCIL and PREDNISOLONE used as a combination alkylating agent and synthetic steroid to treat various leukemias and other neoplasms. It causes gastrointestinal and bone marrow toxicity.
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