AddictionNEO-ADDICTNCT03684317
Primary Dependence to Analgesic Drugs
An observational study of Addiction, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Abuse of analgesics represents an important part of prescription drug abuse. The consequences in terms of morbidity and mortality at the population level could reach worryingly high levels, as illustrated by the US context. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Addiction
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2019to 30 Apr 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects included in the SNIIRAM database (affiliated to the 3 French main Insurance Scheme)
Who may be able to join
- Subjects included in the SNIIRAM (French National inter-scheme health insurance information system) database
- Age >18 at index date (date of first analgesic dispensing)
- At least three dispensing of analgesic drugs
- At least two years of available follow-up at the date of first analgesic dispensing in the SNIIRAM database
- No dispensing for any of the analgesics of interest in the past 12 months (selection of new users only)
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Primary Dependence to Analgesic Drugs: Development of a Predictive Approach Based on Early Modifications of Drug Use in the Ambulatory Care Setting
Abuse of analgesics represents an important part of prescription drug abuse. The consequences in terms of morbidity and mortality at the population level could reach worryingly high levels, as illustrated by the US context. This issue should not focus only on opioid analgesics, but must also account for some antiepileptics or antidepressants with abuse potential (for example, pregabalin or gabapentin). In France, reports related to tramadol abuse are increasing, in particular since dextropropoxyphene withdrawal. Trends of growing abuse are also reported for other analgesics. Patients with no history of primary dependence constituted a significant proportion of those developing a tramadol abuse. There is therefore a need for early identification of these patients and to raise awareness of health professionals on this issue, in particular in primary care. Given the extensive use of analgesic drugs in France, the problem of primary dependence should not be neglected. Since it will affect people who have no history of drug abuse, strategies for identification and prevention are differing from a population already using psychotropic products for example.
Read the detailed description
To date, prescription drug abuse has been considered in terms of the secondary or tertiary prevention, and primary prevention remains poorly explored. By reconstructing the entire trajectories of patients having developed primary drug dependence, from the genesis of first drug exposures, investigators will identify patients' profiles and early changes in drug use that could accurately predict future complications. Pharmacoepidemiological methods are particularly relevant in the field of abuse and drug dependence. By definition, specialized care seeking can only be achieved after emergence and identification of the problem. Outpatients data obtained through medico-administrative database are then the only source of evidence that could enable to ascertain accurately history of past drug consumption
- Conditions
- Addiction
- Keywords
- Pharmacology, Psychiatry
- Medical subject headings
- Behavior, Addictive
What is being measured
The primary outcome is the main question the study is designed to answer.
occurrence of complications in relation with primary drug dependence
occurrence of complications in relation with primary drug dependence (hospitalization for complications related to analgesic use, long term condition or initiation of drug for opioid dependence)
Measured: 12 months
Secondary outcomes (8)
Incidence of analgesic drug dependence
To estimate incidence of analgesic drug dependence in the French general population using the national SNIIRAM database
Measured: 12 months
Drug consumption in patients with primary dependence to analgesics
Change in duration of treatment between baseline and M12
Measured: 12 months
Drug consumption in patients with primary dependence to analgesics
Change in dose between baseline and M12
Measured: 12 months
Drug consumption in patients with primary dependence to analgesics
Change in number of drugs between baseline and M12
Measured: 12 months
Number of patients with misuse resulting to dependence to analgesics drugs and its morbid consequences
Drug misuse (dose and/or duration superior to recommendations)
Measured: 12 months
Dependance
Doctor shopping behaviour (multiple different prescribers for the same drugs)
Measured: up to 12 months
Initiation of a drug for opioid dependence
Measured: up to 12 months
Mortality
Number of deaths between baseline and M12
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start1 Jun 2019
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Why it stopped: technical problems with database
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maryse Lapeyre-Mestre, MD PhD, Principal investigator, University Hosptial Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03684317
- Sponsor's protocol ID
- RC31/16/8914
- Acronym
- NEO-ADDICT
- Status last verified
- Aug 2026
- First submitted
- 18 Jul 2018
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Dependence to Analgesic Drugs: Development of a Predictive Approach Based on Early Modifications of Drug Use in the Ambulatory Care Setting
- ClinicalTrials.gov ID
- NCT03684317
- Acronym / sponsor ID
- NEO-ADDICT / RC31/16/8914
- Conditions
- Addiction
- Keywords
- Pharmacology, Psychiatry
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: technical problems with database
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 25 Sep 2018 (actual)
- 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.
Abuse of analgesics represents an important part of prescription drug abuse. The consequences in terms of morbidity and mortality at the population level could reach worryingly high levels, as illustrated by the US context. This issue should not focus only on opioid analgesics, but must also account for some antiepileptics or antidepressants with abuse potential (for example, pregabalin or gabapentin). In France, reports related to tramadol abuse are increasing, in particular since dextropropoxyphene withdrawal. Trends of growing abuse are also reported for other analgesics. Patients with no history of primary dependence constituted a significant proportion of those developing a tramadol abuse. There is therefore a need for early identification of these patients and to raise awareness of health professionals on this issue, in particular in primary care. Given the extensive use of analgesic drugs in France, the problem of primary dependence should not be neglected. Since it will affect people who have no history of drug abuse, strategies for identification and prevention are differing from a population already using psychotropic products for example.
Detailed description
To date, prescription drug abuse has been considered in terms of the secondary or tertiary prevention, and primary prevention remains poorly explored. By reconstructing the entire trajectories of patients having developed primary drug dependence, from the genesis of first drug exposures, investigators will identify patients' profiles and early changes in drug use that could accurately predict future complications. Pharmacoepidemiological methods are particularly relevant in the field of abuse and drug dependence. By definition, specialized care seeking can only be achieved after emergence and identification of the problem. Outpatients data obtained through medico-administrative database are then the only source of evidence that could enable to ascertain accurately history of past drug consumption
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects included in the SNIIRAM database (affiliated to the 3 French main Insurance Scheme)
Key inclusion criteria (5 listed)
- Subjects included in the SNIIRAM (French National inter-scheme health insurance information system) database
- Age >18 at index date (date of first analgesic dispensing)
- At least three dispensing of analgesic drugs
- At least two years of available follow-up at the date of first analgesic dispensing in the SNIIRAM database
- No dispensing for any of the analgesics of interest in the past 12 months (selection of new users only)
Key exclusion criteria (1 listed)
- none
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
occurrence of complications in relation with primary drug dependence
Time frame: 12 months
occurrence of complications in relation with primary drug dependence (hospitalization for complications related to analgesic use, long term condition or initiation of drug for opioid dependence)
8 secondary outcomes
Incidence of analgesic drug dependence
Time frame: 12 months
Drug consumption in patients with primary dependence to analgesics
Time frame: 12 months
Drug consumption in patients with primary dependence to analgesics
Time frame: 12 months
Drug consumption in patients with primary dependence to analgesics
Time frame: 12 months
Number of patients with misuse resulting to dependence to analgesics drugs and its morbid consequences
Time frame: 12 months
Dependance
Time frame: up to 12 months
Initiation of a drug for opioid dependence
Time frame: up to 12 months
Mortality
Time frame: up to 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
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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.
Maryse Lapeyre-Mestre, MD PhD principal investigator
University Hosptial Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Addiction, run by University Hospital, Toulouse at 1 site in France.
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 5 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: withdrawn, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 was withdrawn before enrolling participants, so there are no results.
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?
occurrence of complications in relation with primary drug dependence (time frame: 12 months). 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 31 Aug 2026.