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Last Updated: June 28, 2022

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 >Phase >Summary

Clinical Trial Conditions for GSI-136

Condition Name

Condition Name for
Intervention Trials
Alzheimer Disease 4
Healthy 4
Adult Angiosarcoma 1
Ovarian Sarcoma 1
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Condition MeSH

Condition MeSH for
Intervention Trials
Alzheimer Disease 4
Osteosarcoma 2
Neoplasms 2
Gastrointestinal Stromal Tumors 1
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Clinical Trial Locations for GSI-136

Trials by Country

Trials by Country for
Location Trials
United States 10
Germany 6
Japan 2
Italy 1
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Trials by US State

Trials by US State for
Location Trials
New York 3
Michigan 1
Massachusetts 1
Florida 1
California 1
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Clinical Trial Progress for GSI-136

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 3 2
Phase 2 1
Phase 1/Phase 2 3
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Completed 9
Withdrawn 1
Not yet recruiting 1
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Clinical Trial Sponsors for GSI-136

Sponsor Name

Sponsor Name for
Sponsor Trials
Wyeth is now a wholly owned subsidiary of Pfizer 5
National Cancer Institute (NCI) 3
Universitätsklinikum Hamburg-Eppendorf 1
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Sponsor Type

Sponsor Type for
Sponsor Trials
Other 22
Industry 8
NIH 3
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