1 / 22

Hospital Universitari Vall d’ Hebron de Barcelona

Direcció General de Drogodependències i SIDA Generalitat de Catalunya.

sirius
Download Presentation

Hospital Universitari Vall d’ Hebron de Barcelona

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Direcció General de Drogodependències i SIDA Generalitat de Catalunya COMPARATIVE STUDY OF THE EFICACY OF ORAL ADMINISTRATION OF DIACETYLMORPHINE, MORPHINE AND METHADONE IN MAINTENANCE TREATMENT OF HEROIN DEPENDENT PATIENTS WHO HAVE RELAPSED IN METHADONE MAINTENANCE PROGRAMS Hospital Universitari Vall d’ Hebron de Barcelona Hospital de la Santa Creu i Sant Pau Hospital Mútua de Terrassa

  2. ORAL HEROIN CLINICAL TRIAL PATHOLOGY IN STUDY • Opioid dependence ( DSM-IV-RT ) smoked or taken intravenously, amongst patients who have been unsuccessfulin at least twomethadone maintenance programs that lasted a minimum of one month, and in which the dose was equal to or more than 70 mg. of oral methadone per day. • Active illegal heroin use.

  3. ORAL HEROIN CLINICAL TRIAL Effectiveness of oral heroin : - The Swiss project PROVE studied diverse means of heroin administration : • Intravenous • Smoked • Inhaled • Oral • Suppositories • Transcutaneous

  4. ORAL HEROIN CLINICAL TRIAL DESIGN • First clinical trial of a product in clinical research phase ( PEI ) . • Comparison of three opioid substances in 4 groups: • Group I : 12 hour controlled release oral diacetylmorphine. • Group II : 12 hour controlled release oral morphine. • Group III : Single dose oral methadone plus placebo. • Group IV : Double dose oral methadone.

  5. ORAL HEROIN CLINICAL TRIAL • Clinical Trial Phase III • Design: Controlled, double blind, in parallel, of 4 randomly assigned experimental groups . • Flexible dose Patient Physician

  6. ORAL HEROIN CLINICAL TRIAL Length: 6 months DESIGN • Induction phase: 14 days hospitilization. • Maintenance phase: 166 days of outpatient with 2 daily doses.

  7. ORAL HEROIN CLINICAL TRIAL DESIGN • Total number of patients = 180 • Patients per center n = 60 • Diacetylmorphine n = 15 • Morphine n = 15 • Metadone I n = 15 • Metadone II n = 15 X 3 X 3 X 3 X 3 X 3

  8. ORAL HEROIN CLINICAL TRIAL MAIN VARIABLES 1.- Subject treatment retention in the study. 2.- Consumption of non - prescribed opioids.

  9. ORAL HEROIN CLINICAL TRIAL SECONDARY OBJECTIVES • Establish the daily dose of oral diacetylmorphine necessary to bring to completion a maintenance program using this opioid. • Establish the daily dose of oral morphine necessary to bring to completion a maintenance program using this opioid.

  10. ORAL HEROIN CLINICAL TRIAL SECONDARY OBJECTIVES • Establish the equivalence dose between diacetylmorphine and oral methadone in a maintenance program. • Establish the equivalence dose between oral morphine and oral methadone in a maintenance program.

  11. ORAL HEROIN CLINICAL TRIAL SECONDARY OBJECTIVES • Compare the total daily dosage of oral methadone when administered in single dose or in divided doses. • Compare the dose increment patterns of oral methadone, oral diacetylmorphine, and oral morphine during the course of the trial. • Compare the presence of concomitant psycho-pathology between the four groups.

  12. ORAL HEROIN CLINICAL TRIAL SECONDARY OBJECTIVES • Compare the use of non - opioid psychoactive substances between groups over the course of the study. • Compare the presence of other risk behaviors between groups during the study.

  13. ORAL HEROIN CLINICAL TRIAL INCLUSION CRITERIA - I - • Current heroin dependence (physiological), according to DSM-IV-RT criteria, taken orally or smoked, . • Between 18 and 45 years of age. • Opioid maintenance treatment is indicated at the present time.

  14. ORAL HEROIN CLINICAL TRIAL INCLUSION CRITERIA - II - • Lack of success in at least two Methadone Maintenance Programs. Lack of success is defined as dropping out of a MMP and returning to heroin use. Each of the two MMPs should have been followed for a period of at least one month, with an oral methadone dose of at least 60 mg / day. • At least one positive urinalysis for opioids, excluding methadone, in the week before the induction phase.

  15. ORAL HEROIN CLINICAL TRIAL INCLUSION CRITERIA - III - • Demonstrated capacity to grant and sign the pertinent informed consent . • Usual residence compatible with daily attendance at the dispensing center. • For women, acceptance of using effective contraceptive measures during the clinical trial.

  16. ORAL HEROIN CLINICAL TRIAL EXCLUSION CRITERIA - I - • Pregnancy and natural lactation. • Serum liser transaminase concentrations 5 times higher than normal. • Diagnosis of grave physical conditions such as unstable diabetes, active tuberculosis, AIDS (seropositive patients without clinical symptoms can be included), kidney, heart, or renal problems.

  17. ORAL HEROIN CLINICAL TRIAL EXCLUSION CRITERIA - II - • Current diagnosis, according to DSM-IV-RT criteria, of the following disorders: Active alcohol, sedative and / or hypnotic dependence, major depression, bipolar disorder, schizophrenia or other psychotic disorders. • Positive urinalysis for methadone at the outset of the phase prior to treatment induction or following a methadone maintenance program during the previous 30 days.

  18. ORAL HEROIN CLINICAL TRIAL EXCLUSION CRITERIA - III - • Prior knowledge of situation that could impede the patient's participation in the trial ( e.g. serving a prison sentence ). • Current participation in another research project

  19. ORAL HEROIN CLINICAL TRIAL EXCLUSION CRITERIA - IV - • Current treatment, or the awareness that the patient will initiate treatment during the course of the study, with any of the following medications that could modify the effectiveness of methadone : • Carbamazepine - Amonium chloride • Phenobarbitol - Phennitoine • Rifabutine - Rifampicine • Eritromicine - Ketoconazol • Fluconazol - Nevirapine • Cimetidine • Antidepresants: MAOS, Tricyclics, fluoxetine, fluvoxamine and paroxetine • Antirretrovirals protease inhibitors: ritonavir and others.

  20. Direcció General de Drogodependències i SIDA Generalitat de Catalunya COMPARATIVE STUDY OF THE EFICACY OF ORAL ADMINISTRATION OF DIACETYLMORPHINE, MORPHINE AND METHADONE IN MAINTENANCE TREATMENT OF HEROIN DEPENDENT PATIENTS WHO HAVE RELAPSED IN METHADONE MAINTENANCE PROGRAMS Hospital Universitari Vall d’ Hebron de Barcelona Hospital de la Santa Creu i Sant Pau Hospital Mútua de Terrassa

More Related