Survey of Buprenorphine Use Among "Out of Care" Populatio... | NCT00756353

Studies
Survey of Buprenorphine Use Among "Out of Care" Population in France (P04933)(COMPLETED)

NCT00756353

Sponsor

Indivior Inc.

Status

Completed

Last Update Posted

Mar 20, 2023Actual

Enrollment

600Actual

Phase

Not provided

Conditions

Drug Addiction

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2006

Primary Completion Date

Dec 2006Actual

Completion Date

Dec 2006Actual

First Submitted Date

Sep 19, 2008

First Submission Date that Met QC Criteria

Sep 19, 2008

First Posted Date

Sep 22, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2023

Last Update Posted Date

Mar 20, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study was a survey of drug users who obtain buprenorphine from the black market and have used buprenorphine during the last month. Subjects were surveyed at various locations (streets, railway stations, etc.) with a few simple questions in order to describe the use of buprenorphine in this "out of care" population.

Detailed Description

Participants were found from various places and using a "snow ball" technique.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

600Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The objective of this survey is to describe quantitatively and qualitatively, the use of buprenorphine in the population who obtain buprenorphine only on black market or both on black market and in pharmacy.		Not Applicable, cross-sectional description.

Secondary Outcomes

Measure	Description	Time Frame
This survey will provide data on patients in regards to their own experience in drug addiction.		Not Applicable, cross-sectional description.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Drug users who have obtained buprenorphine only on the black market or both on black market and in pharmacy.

Exclusion Criteria:

Patients who have obtained buprenorphine only from the pharmacy.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

The population in this survey includes drug users who are in the "out of care" population, found in various places (streets, railway stations) and via the "snow ball" technique.

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D019966	Substance-Related Disorders

Ancestor Terms

ID	Term
D064419	Chemically-Induced Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
Wave 1
Wave 2