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Opioid-Related DisordersSTUD_TOXNCT03859778

Evaluation of Pharmacy Students' Perception of Opioid / Opiate Dependence

An observational study of Opioid-Related Disorders, run by University Hospital, Clermont-Ferrand at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The pharmacist in his professional activity may have to manage opioid dependent patients. This professional activity will result in the provision of opioid substitution treatment (OST), single-use syringes, harm reduction kits and a prevention advice for the reduction of toxicity and infection risks. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Opioid-Related Disorders
What is being tested?
survey
How many people
2,034 participants
Where
1 siteFrance
Study dates
14 Jan 2019to 31 Mar 2019
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
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: French pharmacy students

Who may be able to join

  • French pharmacy students

Who cannot join

  • Age <18 years
  • Other health students
  • Graduated pharmacist
  • First year pharmacy student

Trial locations and contacts

1 site in 1 country.

France1 site
  • Chu Clermont-Ferrand

    Clermont-Ferrand, 63003

Other trials in France

About this study

Official title: Evaluation of Pharmacy Students' Perception of Opioid / Opiate Dependence: Cross-sectional National Study

The pharmacist in his professional activity may have to manage opioid dependent patients. This professional activity will result in the provision of opioid substitution treatment (OST), single-use syringes, harm reduction kits and a prevention advice for the reduction of toxicity and infection risks.

Since the 1990s, the consumption of OST has been steadily increasing. According to the OFDT (French Observatory of Drugs and Drug Addiction), the number of patients under OST is about 150 000 patients. Since high-dose buprenorphine is prescribed for approximately two-thirds of patients, it remains the most frequently prescribed OST in France.

Read more

Recently, a French association assisting drug users (ASUD - Auto-support des usagers de drogues) performed a study in Paris (20/07/2018 - 25/08/2018) to assess the delivery of opioid replacement therapies by community pharmacists. In this study, 71% of pharmacists refused to deliver opioid replacement therapies. The main reasons reported were security (56%) and activity saturation, meaning that pharmacists considered that they had too many patients using opioid drugs. In France, the refusal of a pharmacist to deliver drugs is a punishable offence. According to the Code of ethics of pharmacists, pharmacists must respect life and people without discrimination. Pharmacists have a low perception of patients suffering from opioid addiction. Another study performed by ASUD in 93 community pharmacies, showed that pharmacists used the term "toxicomaniacs" instead of "drug users". Most pharmacists had had a bad experience with drugs users, with physical and verbal aggressions. The conclusions of this study showed that pharmacists lacked knowledge of drug users and drug use. Pharmacists knew about harm reduction kits for opioid users (containing sterile syringes, needles, water, antiseptics, etc.) and had already opened them, but very few knew how to use them. More worryingly, some pharmacists did not understand the harm reduction strategies available It thus appears that community pharmacists have a difficult relationship with opioid-dependent patients, even though these pharmacists have received education in the management of addictions during their studies. Indeed, it can consider that these courses should help to better understand the addictive disease both in its nosological / semiological and therapeutic components. Thus, it would be interesting to evaluate the impact of addiction education on pharmacists' perception of opioid dependence. In this perspective, it would be interesting to focus on pharmacy students.

The objective of this study will be to evaluate the perception by pharmacy students of opioid dependent patients. Investigator would like to know if pharmacy students consider opioid addiction to be an illness and whether having taken education on drug use and addictions changes this perception.

Read the detailed description

This observational and cross-sectional study will be conducted as a survey using the REDCap software and the response to this survey will be done online, in real time, with an automatic, secure and centralized data collection (CHU Clermont-Ferrand).

French pharmacy students will be contacted by email thanks to the student associations and scolarity departments. Answer to the survey will be done online.

Being tested
survey
Keywords
Opioid-Related Disorders, student, Community Pharmacy Services
Medical subject headings
Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • surveyOther

    French pharmacy students will be contacted by email thanks to the student associations and scolarity departments. Answer to the survey will be done online

Study groups in NCT03859778
Study groupRoleWhat they receive
pharmacy studentsNot described
Receives: Other: survey

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Perception of opioid / opiate dependence as a disease

    visual analogic scale: -10 (it is not a disease), 0 (neutral) and +10(it is a disease)

    Measured: At day 1

Secondary outcomes (17)
  1. Proportion of courses on drug addiction during pharmacy studies

    yes/no (percentage)

    Measured: At day 1

  2. Study year of courses on drug addiction during pharmacy studies

    2nd, 3rd, 4th, 5th and/or 6th year of study in pharmacy

    Measured: At day 1

  3. Perception of the pharmacist's missions on the dispensing of opioid substitution treatments (buprenorphine and methadone) and harm reduction kit / single use syringe

    visual analogic scale: -10 (it's not normal), 0 (neutral) and +10 (it's normal)

    Measured: At day 1

  4. Perception of the efficacy of opioid substitution treatments (buprenorphine and methadone)

    visual analogic scale: -10 (it is not effective), 0 (neutral) and +10 (it is effective)

    Measured: At day 1

  5. Proportion of realization of internships or temporary employment in pharmacy

    yes / no (percentage)

    Measured: At day 1

  6. Proportion of delivery of opioid substitution treatments (buprenorphine and methadone)

    yes / no (percentage)

    Measured: At day 1

  7. Proportion of tobacco (cigarettes) use

    yes / no (percentage)

    Measured: At day 1

  8. Proportion of electronic cigarettes use

    yes / no (percentage)

    Measured: At day 1

  9. Proportion of alcohol use

    yes / no (percentage)

    Measured: At day 1

  10. Proportion of alcohol use (>10 alcohol units per week)

    yes / no (percentage)

    Measured: At day 1

  11. Proportion of cannabis use

    yes / no (percentage)

    Measured: At day 1

  12. Frequency of cannabis use (for users)

    Daily, weekly, monthly, occasional or experimentation

    Measured: At day 1

  13. Proportion of personal experience with a relative having or having had a problem of drug use

    yes / no (percentage)

    Measured: At day 1

  14. Academic year in pharmacy at the time of the answer

    2nd / 3rd / 4th / 5th / 6th year of study in pharmacy

    Measured: At day 1

  15. Estimation of attendance to courses

    Visual analogic scale: 0 (no attendance) - 100 (full attendance)

    Measured: At day 1

  16. Estimation of annual average mark during the past university year

    <10, 10-12, 12-14, 14-16 and >16/20

    Measured: At day 1

  17. Demographic information

    age and sex

    Measured: At day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2019
  2. Study start14 Jan 2019
  3. Primary completion31 Mar 2019
  4. Study completion31 Mar 2019

Resources

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
Cross-sectional
Enrolment
2,034 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03859778
Sponsor's protocol ID
CHU-427
Acronym
STUD_TOX
Status last verified
Feb 2019
First submitted
21 Feb 2019
Last updated
24 May 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Opioid-Related Disorders, run by University Hospital, Clermont-Ferrand 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 1 inclusion and 4 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 24 May 2019. 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 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?

Perception of opioid / opiate dependence as a disease (time frame: At day 1). 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 24 May 2019.

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