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Patients who admit to using buprenorphine by the intravenous route will be randomized to either Subutex or Suboxone and be followed up for 3 months to determine if there is less injection with Suboxone than with Subutex based primarily on patient diaries.
Patients randomized to Suboxone may continue to receive the product for a further 9 months at their request and will be monitored at 3 month intervals.
Patients will receive a payment for the inconvenience of keeping a daily diary and to cover their travel expenses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subutex | Active Comparator |
| |
| Suboxone | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Buprenorphine (Subutex) | Drug | Sublingual tablet |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| number of study drug injections per week | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Addiction severity | 3 months | |
| Withdrawal severity | 1 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Didier TOUZEAU, MD | Hôpital Paul Guiraud, Bagneux | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Csst Antibes | Antibes | France | ||||
| Hopital Paul Guiraud |
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| Buprenorphine/naloxone (Suboxone) | Drug | Sublingual tablet |
|
|
| Bagneux |
| France |
| Cssa Bizia | Bayonne | France |
| Centre Carreire , CH Charles Perrens | Bordeaux | France |
| CHU de Clermont-Ferrand, Centre Méthadone | Clermont-Ferrand | France |
| Service d'addictologie, Hopital de Dole | Dole | France |
| CSST NAUTILIA (Ex Alinea) | Le Havre | France |
| CSST Le Cèdre Bleu | Lille | France |
| Centre Hospitalier Esquirol - Intersecteur, Regional Soins en Addictologie | Limoges | France |
| Centre Baudelaire | Metz | France |
| Csst de Montauban | Montauban | France |
| CSST Centre Hospitalier | Nice | France |
| CSST Logos | Nîmes | France |
| Hôpital Caremeau | Nîmes | France |
| Csst Espace Murger | Paris | France |
| Hôpital Saint Anne | Paris | France |
| Centre L'Envol (Csst) | Rennes | France |
| Centre Baudelaire | Thionville | France |
| Hopital Joseph Ducuing | Toulouse | France |
| CSST Centre Port Bretagne CH Charles Perrens | Tours | France |
| ID | Term |
|---|---|
| D015819 | Substance Abuse, Intravenous |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D002047 | Buprenorphine |
| D009270 | Naloxone |
| D000069479 | Buprenorphine, Naloxone Drug Combination |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
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