Drug AddictionNCT00756353
Survey of Buprenorphine Use Among "Out of Care" Population in France (P04933)(COMPLETED)
An observational study of Drug Addiction, run by Indivior Inc..
Trial 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"… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Drug Addiction
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- Jun 2006to Dec 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older 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.
Who may be able to join
- Drug users who have obtained buprenorphine only on the black market or both on black market and in pharmacy.
Who cannot join
- Patients who have obtained buprenorphine only from the pharmacy.
About this study
Official title: Out of Care Patient Survey
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.
Read the detailed description
Participants were found from various places and using a "snow ball" technique.
- Conditions
- Drug Addiction
- Keywords
- Heroin, Buprenorphine use
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Wave 1 | Not described | |
| Wave 2 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Not Applicable, cross-sectional description.
Secondary outcomes (1)
This survey will provide data on patients in regards to their own experience in drug addiction.
Measured: Not Applicable, cross-sectional description.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2008 (estimated)
- Study startJun 2006
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug AddictionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indivior Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00756353
- Sponsor's protocol ID
- P04933
- Status last verified
- Mar 2023
- First submitted
- 19 Sep 2008
- Last updated
- 20 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Out of Care Patient Survey
- ClinicalTrials.gov ID
- NCT00756353
- Acronym / sponsor ID
- P04933
- Conditions
- Drug Addiction
- Keywords
- Heroin, Buprenorphine use
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Indivior Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 22 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Wave 1 | – | – |
| Wave 2 | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older 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.
Key inclusion criteria (1 listed)
- Drug users who have obtained buprenorphine only on the black market or both on black market and in pharmacy.
Key exclusion criteria (1 listed)
- Patients who have obtained buprenorphine only from the pharmacy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: Not Applicable, cross-sectional description.
1 secondary outcome
This survey will provide data on patients in regards to their own experience in drug addiction.
Time frame: Not Applicable, cross-sectional description.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug Addiction, run by Indivior Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Not Applicable, cross-sectional description.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2023.