|
Protocol: PEPSA 2001
Comparative, randomized and open study on the difference between a diversified prescription use of opioid agonist backed by intravenous diacetylmorphine and the prescription of oral methadone -- both treatments administered as individualized procedures following appropriate protocols and with medical and psychosocial support -- through a nine month period for the treatment of opiate dependent patients who have failed under previous treatments. This is an experimental drug prescription experimental program in Andalusia (PEPSA).
Authors
§ Miguel Marset Fernández.
§ Antonio Hevia Alonso.
§ Francisco Carrasco Limón.
§ Emilio Perea-Milla López.
§ Rosario Ballesta Gómez.
§ Carmen Aceijas Hernández.
§ Emilio Sánchez-Cantalejo Ramírez.
§ Francisco Martos Crespo.
§ Isabel Ruiz Pérez.
§ Francisco Martos Crespo.
§ Isabel Ruiz Pérez.
§ Joan Carles March Cerdà.
§ Francisco Giner.
§ Sebastián Rinken.
§ Mª Victoria Zunzunegui.
Address
§ Andalusian School of Public Health, (Escuela Andaluza de Salud Pública --EASP)
§ Joan Carles March Cerdà
§ Campus of Cartuja
§ Apartado 2070
§ Granada 18080
§ Spain
§ Telephone: +34-958-02.74.00
§ Fax: +34-958-02.75.03
§ e-mail :joancarles.march.easp@juntadeandalucia.es
Summary
Type of application:
§ First clinical trial of diacetylmorphine through intravenous injection with PEI approval.
Information about the sponsor:
§ Andalusian Commissioner on Drug Addictions. Council of Social Affairs. (Comisionado Andaluz para las Drogodependencias. Consejería de Asuntos Sociales).
§ Avda Hytasa, s/n. 41071 - Sevilla. Spain.
§ Teléfono: +34-955-048332/3
§ Fax +34-955-048346
Name of the study:
COMPARATIVE, RANDOMIZED AND OPEN STUDY ON THE DIFFERENCE BETWEEN A DIVERSIFIED PRESCRIPTION USE OF OPIOID AGONIST BACKED BY INTRAVENOUS DIACETYLMORPHINE* AND THE PRESCRIPTION OF ORAL METHADONE – BOTH TREATMENTS ADMINISTERED AS INDIVIDUALIZED PROCEDURES FOLLOWING APPROPRIATE PROTOCOLS AND WITH MEDICAL AND PSYCHOSOCIAL SUPPORT – THROUGH A NINE MONTH PERIOD FOR THE TREATMENT OF OPIATE DEPENDENT PATIENTS WHO HAVE FAILED UNDER PREVIOUS TREATMENTS. THIS IS AN EXPERIMENTAL DRUG PRESCRIPTION EXPERIMENTAL PROGRAM IN ANDALUSIA (PEPSA).
Code of Protocol:
PEPSA 2001
General Coordination :
José Manuel Rodríguez López
Fº Andaluza para la atención a las drogodependencias (FADA)
Avd. Hytassa. Edificio: Toledo II, módulo 3, 2ª planta.
41006 Sevilla
Teléfono: 955 05 32 70
Fax: 955 05 32 80
www.fundacion-fada.org
Researchers:
|
Lead Resercher |
Joan Carles March Cerdá |
|
Co-lead resercher |
Emilio Perea-Milla López
|
|
Reserchers |
Francisco Carrasco Limón
Rosario Ballesta Gómez
Josefa Gutiérrez Ortega
Francisco González Sáiz
Salvador Rodríguez
|
Centre:
§ Centro de Tratamiento PEPSA Granada (Center of Treatment, PEPSA, Granada. Spain)
CEIC
We have obtained approval from the Ethics Committee of Clinical Research of the University Hospital Virgen de las Nieves of Granada (center of Granada. Spain)
Monitoring
§ Antonio Hevia Alonso, Cristina Meseguer Calero and Clara Rosso Fernández.
§ Ardes: Unidad de Farmacología Clínica
§ University Hospitals Virgen del Rocío, Servicio Andaluz de Salud. Sevilla. Spain
§ Telephone: +34- 955013173- 176
§ Fax: +34-955013176
§ e-mail : ahevia@hvr.sas.cica.es
Products and experimental processes and control
|
Experimental Group |
Control Group |
|
§ Methadone:
o Dosage between 20 and 60 mg. /day
o The methadone will be administered orally.
o The methadone will be dispensed according to daily monodosis guidelines.
o Decisions regarding dosage and the administering guidelines will be developed individually.
o The maximum dosage may be surpassed in exceptional cases, which must be properly documented.
§ Medical program of medical-psychosocial support for both groups. |
§ Methadone:
o Dosage between 40 and 150 mg. /day
o The methadone will be administered orally.
o The methadone will be dispensed according to daily monodosis guidelines.
o Decisions regarding dosage and the administering guidelines will be developed individually.
o The maximum dosage may be surpassed in exceptional cases, which must be properly documented.
§ Medical program of medical-psychosocial support for both groups. |
|
§ Diacetylmorphine:
o Dosage between 100 and 500 mg. /day
o The diacetylmorphine will be administered through intravenous injection.
o Decisions regarding the dosage and administering guidelines will be developed individually.
o The maximum dosage may be surpassed in exceptional cases, which must be properly documented. |
|
Phase of controlled trial :
Controlled trial in Phase III.
Design :
This is the first controlled trial that is random and open with parallel groups.
Pathology to evaluate :
Opiate dependence through intravenous injection reflected in the treatments currently available.
Main objective:
“To show that the individualized, diversified and protocolized prescription of opioid agonist backed by intravenous diacetylmorphine is more efficient than the prescription of oral methadone – both done with appropriate medical and psychosocial support – in the improvement of the mental and physical health and in the social integration of opiate addicts who take drugs by intravenous injection, when the addicts are, according to criteria of the CIE-10, users of multiple drugs who have serious psychological, medical, sanitary problems, with economic needs who are socially excluded and who have previously failed in at least two available standard treatments.
Secondary objectives:
§ To show that the diversified, individualized and protocolized prescription of opioid agonist backed by intravenous diacetylmorphine is more efficient than the prescription of oral methadone, both cases under appropriate medical and psychosocial support, in relation to:
1. Improved state of health.
2. Improved quality of life
3. Decreased severity of addiction.
4. Decreased illegal consumption of heroine.
5. Decreased consumption of cocaine.
6. Decreased consumption of other substances that are psychoactive but not medically prescribed.
7. Decreased risk of behavior that could lead to HIV or hepatitis C.
8. Improved psychological adjustment.
9. Improved family adjustment.
10. Improved social situation.
§ To increase the rate of retention in the processing program.
§ To evaluate the safety of administered treatments.
§ To analyze any differences in each group’s utilization of psychosocial services.
Main variables for evaluation :
Consumption of drugs and general state of health
1. General state of health
2. Quality of life
3. Severity of the addiction.
4. Consumption of illegal opiate
5. Consumption of cocaine.
6. Consumption of other psychoactive substances, illegal or legal, not prescribed.
7. Behavior that puts the patient at risk of contracting HIV and hepatitis C
8. Psychological adjustment
9. Symptoms of depression
10. Symptoms of anxiety
Associated family situation
1. Family situation
2. Social support
Program
1. Rate of retention.
2. Level of utilization of the psychosocial services of the trial
Security
1. Accumulated incidents of serious adverse effects to the end of the trial.
Population of study and size of simple :
|
Subjects of study |
Location of Study |
Size of sample |
|
§ People dependent on opiates through intravenous injection who have consumed daily in the last 30 days who, following the criteria set by CIE-10
§ Are at least 18 years of age
§ Are users of multiple drugs with serious medical, sanitary and psychological problems, who are in economic need and have social problems and who have failed with other available treatments.
|
§ City of Granada, Spain
|
§ Experimental group: 120 people (diacetylmorphine intravenous and oral methadone)
§ Control group: 120 people (oral methadone)
|
Statistical analysis:
Descriptive statistics and bi-variable analysis for both groups, experimental and control. Multi-varied analysis for the control of confounding variables and to detect any interaction with the process group by using a regression logistic multiple model for dichotomous dependents, and Cox proportional risks model for variables with censored data. Multilevel analysis model for the repeated appraisal of measures.
Length of treatment:
The length of treatment is nine months.
Calendar and projected date of completion:
§ Initiate recruitment: February 2003
§ Start date: February 2003
§ Phase of Treatment: Agost 2003
§ Statistical analysis and the completion of preliminary report: end 2004
|
