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.
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.
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.
- Conditions
- Opioid-Related Disorders
- 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 group | Role | What they receive |
|---|---|---|
| pharmacy students | Not described Receives: Other: survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Proportion of courses on drug addiction during pharmacy studies
yes/no (percentage)
Measured: At day 1
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
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
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
Proportion of realization of internships or temporary employment in pharmacy
yes / no (percentage)
Measured: At day 1
Proportion of delivery of opioid substitution treatments (buprenorphine and methadone)
yes / no (percentage)
Measured: At day 1
Proportion of tobacco (cigarettes) use
yes / no (percentage)
Measured: At day 1
Proportion of electronic cigarettes use
yes / no (percentage)
Measured: At day 1
Proportion of alcohol use
yes / no (percentage)
Measured: At day 1
Proportion of alcohol use (>10 alcohol units per week)
yes / no (percentage)
Measured: At day 1
Proportion of cannabis use
yes / no (percentage)
Measured: At day 1
Frequency of cannabis use (for users)
Daily, weekly, monthly, occasional or experimentation
Measured: At day 1
Proportion of personal experience with a relative having or having had a problem of drug use
yes / no (percentage)
Measured: At day 1
Academic year in pharmacy at the time of the answer
2nd / 3rd / 4th / 5th / 6th year of study in pharmacy
Measured: At day 1
Estimation of attendance to courses
Visual analogic scale: 0 (no attendance) - 100 (full attendance)
Measured: At day 1
Estimation of annual average mark during the past university year
<10, 10-12, 12-14, 14-16 and >16/20
Measured: At day 1
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.
- First posted1 Mar 2019
- Study start14 Jan 2019
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-Related DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 2,034 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- UFR Pharmacie (Clermont-Ferrand)
- Responsible party
- Sponsor
- Investigators
- David BALAYSSAC, Principal investigator, University Hospital, Clermont-Ferrand
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
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pharmacy Students' Perception of Opioid / Opiate Dependence: Cross-sectional National Study
- ClinicalTrials.gov ID
- NCT03859778
- Acronym / sponsor ID
- STUD_TOX / CHU-427
- Conditions
- Opioid-Related Disorders
- Keywords
- Opioid-Related Disorders, student, Community Pharmacy Services
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,034 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- UFR Pharmacie (Clermont-Ferrand)
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 1 Mar 2019 (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.
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.
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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pharmacy students | – | Other: survey |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- French pharmacy students
Key inclusion criteria (1 listed)
- French pharmacy students
Key exclusion criteria (4 listed)
- Age <18 years
- Other health students
- Graduated pharmacist
- First year pharmacy student
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surveyFrench pharmacy students will be contacted by email thanks to the student associations and scolarity departments. Answer to the survey will be done online | Other | pharmacy students |
Primary outcome
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)
17 secondary outcomes
Proportion of courses on drug addiction during pharmacy studies
Time frame: At day 1
Study year of courses on drug addiction during pharmacy studies
Time frame: 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
Time frame: At day 1
Perception of the efficacy of opioid substitution treatments (buprenorphine and methadone)
Time frame: At day 1
Proportion of realization of internships or temporary employment in pharmacy
Time frame: At day 1
Proportion of delivery of opioid substitution treatments (buprenorphine and methadone)
Time frame: At day 1
Proportion of tobacco (cigarettes) use
Time frame: At day 1
Proportion of electronic cigarettes use
Time frame: At day 1
Proportion of alcohol use
Time frame: At day 1
Proportion of alcohol use (>10 alcohol units per week)
Time frame: At day 1
Proportion of cannabis use
Time frame: At day 1
Frequency of cannabis use (for users)
Time frame: At day 1
Proportion of personal experience with a relative having or having had a problem of drug use
Time frame: At day 1
Academic year in pharmacy at the time of the answer
Time frame: At day 1
Estimation of attendance to courses
Time frame: At day 1
Estimation of annual average mark during the past university year
Time frame: At day 1
Demographic information
Time frame: At day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2019.
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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.
David BALAYSSAC principal investigator
University Hospital, Clermont-Ferrand
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 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.