CLINICAL TRIALS PROFILE FOR GSI-136
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Clinical Trials for GSI-136
| Trial ID | Title | Status | Sponsor | Phase | Summary |
|---|---|---|---|---|---|
| NCT00268814 ↗ | The German Project of Heroin Assisted Treatment of Opiate Dependent Patients | Completed | City of Bonn | Phase 3 | The study will test the hypotheses that heroin assisted treatment, compared to methadone maintenance treatment, is more effective with regard to - the improvement of health, - reduction of illicit drug consumption, - decrease of criminal behaviour, - rise in the accessibility and retainment, - detachment from a social drug context, - social stabilisation in the sense of new drug-free contacts, improved vocational circumstances, financial security, stabilisation of the living situation, - enrollment in subsequent treatment in the case of heroin dependent persons who could not be effectively reached or successfully treated so far, and it will check which is the optimal treatment setting with regard to these aims. The medication is injectable pure heroin (diacetylmorphine) 3x/d, or d l methadone 1x/d The study design is multicentre, open, randomised, 4 x 2 stratified. The study duration is 24 months (individual period of investigation), 1. study phase: 12 moths (protocol part B) and 2. study phase: 12 moths (part C). Patients recruited have an opiate dependency according to ICD-10, who are not being treated currently or who are in a methadone maintenance programme with an unsatisfactory course of treatment. |
| NCT00268814 ↗ | The German Project of Heroin Assisted Treatment of Opiate Dependent Patients | Completed | City of Cologne | Phase 3 | The study will test the hypotheses that heroin assisted treatment, compared to methadone maintenance treatment, is more effective with regard to - the improvement of health, - reduction of illicit drug consumption, - decrease of criminal behaviour, - rise in the accessibility and retainment, - detachment from a social drug context, - social stabilisation in the sense of new drug-free contacts, improved vocational circumstances, financial security, stabilisation of the living situation, - enrollment in subsequent treatment in the case of heroin dependent persons who could not be effectively reached or successfully treated so far, and it will check which is the optimal treatment setting with regard to these aims. The medication is injectable pure heroin (diacetylmorphine) 3x/d, or d l methadone 1x/d The study design is multicentre, open, randomised, 4 x 2 stratified. The study duration is 24 months (individual period of investigation), 1. study phase: 12 moths (protocol part B) and 2. study phase: 12 moths (part C). Patients recruited have an opiate dependency according to ICD-10, who are not being treated currently or who are in a methadone maintenance programme with an unsatisfactory course of treatment. |
| NCT00268814 ↗ | The German Project of Heroin Assisted Treatment of Opiate Dependent Patients | Completed | City of Frankfurt | Phase 3 | The study will test the hypotheses that heroin assisted treatment, compared to methadone maintenance treatment, is more effective with regard to - the improvement of health, - reduction of illicit drug consumption, - decrease of criminal behaviour, - rise in the accessibility and retainment, - detachment from a social drug context, - social stabilisation in the sense of new drug-free contacts, improved vocational circumstances, financial security, stabilisation of the living situation, - enrollment in subsequent treatment in the case of heroin dependent persons who could not be effectively reached or successfully treated so far, and it will check which is the optimal treatment setting with regard to these aims. The medication is injectable pure heroin (diacetylmorphine) 3x/d, or d l methadone 1x/d The study design is multicentre, open, randomised, 4 x 2 stratified. The study duration is 24 months (individual period of investigation), 1. study phase: 12 moths (protocol part B) and 2. study phase: 12 moths (part C). Patients recruited have an opiate dependency according to ICD-10, who are not being treated currently or who are in a methadone maintenance programme with an unsatisfactory course of treatment. |
| NCT00268814 ↗ | The German Project of Heroin Assisted Treatment of Opiate Dependent Patients | Completed | City of Hamburg | Phase 3 | The study will test the hypotheses that heroin assisted treatment, compared to methadone maintenance treatment, is more effective with regard to - the improvement of health, - reduction of illicit drug consumption, - decrease of criminal behaviour, - rise in the accessibility and retainment, - detachment from a social drug context, - social stabilisation in the sense of new drug-free contacts, improved vocational circumstances, financial security, stabilisation of the living situation, - enrollment in subsequent treatment in the case of heroin dependent persons who could not be effectively reached or successfully treated so far, and it will check which is the optimal treatment setting with regard to these aims. The medication is injectable pure heroin (diacetylmorphine) 3x/d, or d l methadone 1x/d The study design is multicentre, open, randomised, 4 x 2 stratified. The study duration is 24 months (individual period of investigation), 1. study phase: 12 moths (protocol part B) and 2. study phase: 12 moths (part C). Patients recruited have an opiate dependency according to ICD-10, who are not being treated currently or who are in a methadone maintenance programme with an unsatisfactory course of treatment. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Summary |
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