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Evaluation of Pharmacy Students' Perception of Opioid / Opiate Dependence (STUD_TOX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03859778
Recruitment Status : Completed
First Posted : March 1, 2019
Last Update Posted : May 24, 2019
Sponsor:
Collaborator:
UFR Pharmacie (Clermont-Ferrand)
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Study Description
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Brief 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.

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.

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.


Condition or disease Intervention/treatment
Opioid-Related Disorders Other: survey

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.

Study Design
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Study Type : Observational
Actual Enrollment : 2034 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Evaluation of Pharmacy Students' Perception of Opioid / Opiate Dependence: Cross-sectional National Study
Actual Study Start Date : January 14, 2019
Actual Primary Completion Date : March 31, 2019
Actual Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
pharmacy students Other: survey
French pharmacy students will be contacted by email thanks to the student associations and scolarity departments. Answer to the survey will be done online


Outcome Measures
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Primary Outcome Measures :
  1. Perception of opioid / opiate dependence as a disease [ Time Frame: At day 1 ]
    visual analogic scale: -10 (it is not a disease), 0 (neutral) and +10(it is a disease)


Secondary Outcome Measures :
  1. Proportion of courses on drug addiction during pharmacy studies [ Time Frame: At day 1 ]
    yes/no (percentage)

  2. Study year of courses on drug addiction during pharmacy studies [ Time Frame: At day 1 ]
    2nd, 3rd, 4th, 5th and/or 6th year of study in pharmacy

  3. Perception of the pharmacist's missions on the dispensing of opioid substitution treatments (buprenorphine and methadone) and harm reduction kit / single use syringe [ Time Frame: At day 1 ]
    visual analogic scale: -10 (it's not normal), 0 (neutral) and +10 (it's normal)

  4. Perception of the efficacy of opioid substitution treatments (buprenorphine and methadone) [ Time Frame: At day 1 ]
    visual analogic scale: -10 (it is not effective), 0 (neutral) and +10 (it is effective)

  5. Proportion of realization of internships or temporary employment in pharmacy [ Time Frame: At day 1 ]
    yes / no (percentage)

  6. Proportion of delivery of opioid substitution treatments (buprenorphine and methadone) [ Time Frame: At day 1 ]
    yes / no (percentage)

  7. Proportion of tobacco (cigarettes) use [ Time Frame: At day 1 ]
    yes / no (percentage)

  8. Proportion of electronic cigarettes use [ Time Frame: At day 1 ]
    yes / no (percentage)

  9. Proportion of alcohol use [ Time Frame: At day 1 ]
    yes / no (percentage)

  10. Proportion of alcohol use (>10 alcohol units per week) [ Time Frame: At day 1 ]
    yes / no (percentage)

  11. Proportion of cannabis use [ Time Frame: At day 1 ]
    yes / no (percentage)

  12. Frequency of cannabis use (for users) [ Time Frame: At day 1 ]
    Daily, weekly, monthly, occasional or experimentation

  13. Proportion of personal experience with a relative having or having had a problem of drug use [ Time Frame: At day 1 ]
    yes / no (percentage)

  14. Academic year in pharmacy at the time of the answer [ Time Frame: At day 1 ]
    2nd / 3rd / 4th / 5th / 6th year of study in pharmacy

  15. Estimation of attendance to courses [ Time Frame: At day 1 ]
    Visual analogic scale: 0 (no attendance) - 100 (full attendance)

  16. Estimation of annual average mark during the past university year [ Time Frame: At day 1 ]
    <10, 10-12, 12-14, 14-16 and >16/20

  17. Demographic information [ Time Frame: At day 1 ]
    age and sex


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
French pharmacy students
Criteria

Inclusion Criteria:

  • French pharmacy students

Exclusion Criteria:

  • Age <18 years
  • Other health students
  • Graduated pharmacist
  • First year pharmacy student
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03859778


Locations
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France
Chu Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
UFR Pharmacie (Clermont-Ferrand)
Investigators
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Principal Investigator: David BALAYSSAC University Hospital, Clermont-Ferrand
More Information
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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT03859778    
Other Study ID Numbers: CHU-427
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Clermont-Ferrand:
Opioid-Related Disorders
student
Community Pharmacy Services
Additional relevant MeSH terms:
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Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders