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NCT Number: NCT03684317

Primary Dependence to Analgesic Drugs

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.

Why the study stopped: technical problems with database
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Key information

Conditions

Addiction Behavior Behavior, Addictive Compulsive Behavior Impulsive Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital toulouse

Toulouse, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • none

Treatment and study plan

Primary outcomes

  1. 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)

Secondary outcomes

  1. Incidence of analgesic drug dependence

    Time frame: 12 months

    To estimate incidence of analgesic drug dependence in the French general population using the national SNIIRAM database

  2. Drug consumption in patients with primary dependence to analgesics

    Time frame: 12 months

    Change in duration of treatment between baseline and M12

  3. Drug consumption in patients with primary dependence to analgesics

    Time frame: 12 months

    Change in dose between baseline and M12

  4. Drug consumption in patients with primary dependence to analgesics

    Time frame: 12 months

    Change in number of drugs between baseline and M12

  5. Number of patients with misuse resulting to dependence to analgesics drugs and its morbid consequences

    Time frame: 12 months

    Drug misuse (dose and/or duration superior to recommendations)

  6. Dependance

    Time frame: up to 12 months

    Doctor shopping behaviour (multiple different prescribers for the same drugs)

  7. Initiation of a drug for opioid dependence

    Time frame: up to 12 months

  8. Mortality

    Time frame: up to 12 months

    Number of deaths between baseline and M12

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Official study title

Primary Dependence to Analgesic Drugs: Development of a Predictive Approach Based on Early Modifications of Drug Use in the Ambulatory Care Setting

Acronym: NEO-ADDICT

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Sep 25, 2018
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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