NCT03859778

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,034

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 14, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 21, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 1, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2019

Completed
Last Updated

May 24, 2019

Status Verified

February 1, 2019

Enrollment Period

3 months

First QC Date

February 21, 2019

Last Update Submit

May 23, 2019

Conditions

Keywords

Opioid-Related DisordersstudentCommunity Pharmacy Services

Outcome Measures

Primary Outcomes (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)

    At day 1

Secondary Outcomes (17)

  • Proportion of courses on drug addiction during pharmacy studies

    At day 1

  • Study year of courses on drug addiction during pharmacy studies

    At day 1

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

    At day 1

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

    At day 1

  • Proportion of realization of internships or temporary employment in pharmacy

    At day 1

  • +12 more secondary outcomes

Study Arms (1)

pharmacy students

Other: survey

Interventions

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

pharmacy students

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

French pharmacy students

You may qualify if:

  • French pharmacy students

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • David BALAYSSAC

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2019

First Posted

March 1, 2019

Study Start

January 14, 2019

Primary Completion

March 31, 2019

Study Completion

March 31, 2019

Last Updated

May 24, 2019

Record last verified: 2019-02

Locations