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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00723697
Other study ID # P05186
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 2007
Est. completion date February 2010

Study information

Verified date March 2023
Source Indivior Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to assess the risks of abuse, misuse and adverse events related to high dose buprenorphine. Approximately 1250 patients taking Subutex (Schering-Plough) or its Buprenorphine High Dose (BHD) generic (Arrow Laboratories) will participate in this study. Data will be collected using physician questionnaires and self evaluation patient questionnaires at the first visit and visits at 6 and 12 months.


Description:

Approximately 380 physicians will participate in this study. Patients will be enrolled in chronological order of consultations.


Recruitment information / eligibility

Status Completed
Enrollment 1307
Est. completion date February 2010
Est. primary completion date February 2010
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Eligible patients will be those already having a prescription for Subutex or its BHD generic, or being proposed a prescription for Subutex or its BHD generic for the first time when consulting the participating physician. - The patient must have been informed orally and in writing via the information notice and have signed it. Exclusion Criteria: - Criteria of non-eligibility will be related to the contraindications in the Marketing Authorization (MA) of Subutex or its BHD generic

Study Design


Intervention

Drug:
buprenorphine
0.4, 2, or 8 mg sublingual tablets

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Indivior Inc.

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Patients Reporting Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) Number of patients who indicate misuse behaviours on self-questionnaire response at first (D1), 6 month (M6), and 12 month (M12) visits. first visit, 6 months, and 12 months
Primary Number of Patients With Misuse (Injection, Sniffing, Dose Fractionation, Modification of Prescribed Doses, and Combination With Psychotropic Agents) as Reported by Physician. Number of patients with misuse behaviours on physician-questionnaire response at first (D1), 6 month (M6), and 12 month (M12) visits. first visit, 6 months, and 12 months
Secondary Number of Patients Reporting Clinical Consequences of Engaging in Misuse Number of patients with clinical consequences (development or progression of: abscess, nutritional deficiency, dental problems, psychiatric problems including depression, sleep problems, schizophrenia, anxiety, phobias, hallucinations, delirium, withdrawal symptoms, inhibition, suicide attempts and other problems) at first, 6 month, and/or 12 month visit. first visit, 6 months, and 12 months
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