Respiratory DepressionPhase 4COXYNCT05235503
Influence of Δ9-tetrahydrocannabinol (THC) on Oxycodone Induced Ventilatory Depression in Healthy Volunteers
A Phase 4 study testing Medicinal cannabis in combination with oxycodon in people with Respiratory Depression and Cannabis Use, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
Rationale: Opioid misuse and abuse are common problems in the Western world. The rate of unintentional drug overdose is rapidly increasing, not only in the Unites States but also in the Netherlands. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Depression, Cannabis Use, Opioid Use
- What is being tested?
- Medicinal cannabis in combination with oxycodon
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 9 Dec 2021to Jun 2023
- Phase
- Phase 4
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- aged 18-45 years,
- body mass index < 30 kg.m-2,
- able to understand the written informed consent form,
- able to communicate with the staff,
- able and willing to complete the study procedures,
- signed the informed consent form,
- deemed suitable by the investigators.
Who cannot join
- Presence or history of any medical or psychiatric disease (incl. a history of substance abuse, anxiety, or the presence of a painful syndrome such as fibromyalgia);
- Use of any medication in the three months prior to the study (incl. paracetamol or other pain killers), except for oral contraceptives (females);
- Use of more than 21 alcohol units per week;
- Use of cannabis in the 4 weeks prior to the study;
- A positive urinary drug test or a breath alcohol test at screening or on the morning of the experiment;
- Pregnancy, lactating or a positive pregnancy test on the morning of the experiment;
- Participation in another drug trial in the 60 days prior to dosing.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Leiden University Medical Center
Leiden, South Holland, 2333 ZA
Cornelis Jan CJ van Dam, MSc, 31(0)715299797, c.j.van_dam@lumc.nl
Monique van Velzen, Phd, +31(0)715262301, m.van_velzen@lumc.nl
About this study
Rationale:
Opioid misuse and abuse are common problems in the Western world. The rate of unintentional drug overdose is rapidly increasing, not only in the Unites States but also in the Netherlands. Additionally, it is well known that opioids are often used (and abused) in combination with other legal or illicit substances, for example cannabis, including medicinal (i.e. doctor prescribed) cannabis. A major opioid-induced adverse effect is respiratory depression and there are no data that show how oxycodone interacts with cannabis on the ventilatory control system. An appreciable effect is possible given the sedative effects of cannabis. Moreover, investigators previously showed that combining even a low dose of oxycodone (20 mg) with ethanol increased the likelihood of an apneic event (van der Schrier et al. Anesthesiology 2017; 102: 115-122). Because of this side effect and also due to the rising number of addicted chronic opioid users, there is an increasing imminent societal, political and medical interest in advancing research on opioids, opioid-drug interaction and alternatives for the treatment of various chronic illnesses and chronic pain.
Read more
Hypothesis: The investigators hypothesize that cannabis will amplify the ventilatory depressant effect of oxycodone (primary end-point).
Objective: The objective of the study is to quantify the interactive effect of Δ9-tetrahydrocannabinol (THC) and oxycodone on ventilatory control.
Study design: Double blind, randomized cross-over, placebo-controlled design.
Study population: Healthy human volunteers between the age of 18 and 45 years old.
Intervention:
Visit A: placebo capsule at t = 0 min + Bedrocan (22.4 mg THC) at t = 90 and 270 min; Visit B: oxycodone 20 mg at t = 0 min + Bedrocan (22.4 mg THC) at t = 90 and 270 min.
Main study parameters/endpoints:
Primary endpoint: The effect of inhaled THC on ventilation at an end-tidal PCO2 = 55 mmHg without and with concomitant intake of 20 mg oxycodone immediate release (IR) capsule in healthy volunteers 120 min after oxycodone intake.
Secondary endpoints: (1) Outcome of Bowdle and Bond \& Lader questionnaires; (2) Level of sedation; (3) Pain Pressure Threshold; (4) slope of the hypercapnic ventilatory response; (5) plasma concentrations of THC, 11-OH-THC and oxycodone; a secondary analysis will be performed on the pharmacokinetic and pharmacodynamic data (PKPD modeling).
Read the detailed description
General study design The design of the study is randomized, placebo-controlled crossover. Each subject will be studied twice, on one occasion he or she will receive THC and a placebo opioid capsule, and on the other occasion THC and an oxycodone capsule. The visits to the lab will be randomized, the washout period between the two occasions is at least 10 days. Subjects will be evaluated by a physician at screening and only healthy volunteers, aged 18-45 years, with a body mass index < 30 kg.m-2, are eligible to participate in the study.
Upon arrival in the laboratory (K5-120), the investigators will perform a urinary drug test and breath alcohol test. When these tests are positive, the subject is excluded from further participation. A venous and an arterial line will be placed. The venous line is used for fluid administration (NaCl/Glucose 50-100 ml/h), the arterial line is for blood sample drawing.
Next, the first hypercapnic ventilatory responses (HCVR) will be obtained (t = -30 min). This is the pre-drug baseline measurement. At t = 0, the subjects will receive 20 mg oxycodone immediate release or placebo. Next, the investigators will obtain HCVRs at 1-hour intervals until 6 hours after oxycodone/placebo intake. At t = 1.5 h and at t = 4.5 h the subject will inhale 100 mg Bedrocan. Breathing will be measured using the "dynamic end-tidal forcing" (DEF) system. At specific time points the investigators will draw 10 mL blood for measurement of drug concentrations. After 8 hours of measurement, we will assess whether the HCVR is still depressed. If so, the investigators will take another measurement at t = 9 h and reassess the HCVR. If still depressed, a last response will be obtained at t = 10 h. If necessary, the subject will stay overnight in the hospital. This will be decided by the physician-investigator. For example, the subject may still be sedated.
The hypercapnic ventilatory response To obtain the HCVR curve, the subject will rebreathe a gas mixture from a 6 L rebreathing balloon bag containing 7% carbon dioxide in 93% oxygen. The slope of the response and ventilation at 55 mmHg will be used in the analysis.
Oxycodone intake:
At t = 0, the subject will ingest 1 oxycodone 20 mg immediate release or a placebo capsule with 100 mL water. Both drugs will be obtained from the LUMC pharmacy.
Cannabis inhalation: Bedrocan is vaporized using the CE-marked Volcano Medic vaporizer (Storz \& Bickel GmbH \& Co, Tuttlingen, Germany), a safe and reliable method of intrapulmonary administration of cannabinoids. The Volcano heats the homogenized plant material to 210 °C to allow for conversion of the THC acid and CBD acid into THC and CBD vapor for inhalation. The complete 100 mg from the glass vial will be entered into the vaporizing chamber of the Volcano Medic. The vapor will be collected in a 6-L plastic balloon that, after inflation, is detached from the vaporizer and subsequently equipped with a mouthpiece for inhalation. It is our experience that the full content of the balloon is inhaled without any problems within 3-5 min.
The Bedrocan cannabis variety contains 22% THC (220 mg per gram) and less than 1%CBD. It is developed in the Netherlands out of a requirement by the Dutch Health Ministry to have a "high THC" variety available to patients. We will administer 100 mg Bedrocan that contains 22.4-mg THC and less than 1-mg CBD, twice. Bedrocan will be obtained via the Bureau voor Medicinale Cannabis (BMO), a governmental organization (VWS) that obtains cannabis from Bedrocan Int. BV in Veenendaal, The Netherlands.
Blood sampling Ten mL blood samples will be obtained on 14 occasions on each visit (total volume = 112 mL per visit) at t = 30 and 60 min after oxycodone intake and at t = 5, 20, 40, 60, 120, 180, 185, 200, 220, 240, 300 and 360 min after the first THC inhalation. From these sample, the following drugs will be measured: oxycodone, THC, THC's metabolite 11-OH-THC and cannabidiol (CBD). CBD is measured as it is expected that some minor quantities of CBD are present in Bedrocan.
Arterial blood will be collected in EDTA tubes. After blood collection the tubes will preferably be put in ice water in aluminum foiled containers, will be centrifuged within one hour for 10 minutes at 2000 G at 4 °C. The handling of samples will be done with the lights switched off. The plasma will be equally divided in 2 tubes (Brown Sarstedt) (primary and back-up sample). Plasma samples will be stored at a temperature of -80 °C and blood samples will be sent to Analytical Biochemical Laboratory (ABL) B.V., Assen, The Netherlands on dry-ice. Pharmacokinetic analysis will be performed using a validated assay. Determination of drug concentrations will be performed using liquid chromatography with tandem-mass spectrometer detection (LC-MS/MS). Analysis of the samples and acceptance criteria are indicated in ABL Standard Operating Procedure (SOP) 0251.
- Conditions
- Respiratory Depression, Cannabis Use, Opioid Use
- Being tested
- Medicinal cannabis in combination with oxycodon, Medicinal cannabis in combination with placebo oxycodon
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medicinal cannabis in combination with oxycodonDrug
The intervention will be administering the combination of medicinal cannabis in combination with oxycodon
Medicinal cannabis in combination with placebo oxycodonDrug
The intervention will be administering the combination of medicinal cannabis in combination with placebo oxycodon
| Study group | Role | What they receive |
|---|---|---|
| 20mg Oxycodon (capsule) + 100 mg Bedrocan (vaporized) | Experimental | As stated above Receives: Drug: Medicinal cannabis in combination with oxycodon |
| Placebo oxycodon (capsule) + 100 mg Bedrocan (vaporized) | Placebo comparator | As stated above Receives: Drug: Medicinal cannabis in combination with placebo oxycodon |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of inhaled THC on ventilation (Liters per minute) at an end-tidal PCO2 = 55 mmHG without and with concomitant intake of 20 mg oxycodone immediate release (IR) capsule in healthy volunteers 120 min after oxycodone intake.
As stated above
Measured: 120 minutes after oxycodone intake
Secondary outcomes (5)
Bowdle questionnaire score;
Three factors of psychedelic effects can be derived from the Bowdle questionnaire: drug high, internal perception, and external perception. Internal perception reflects inner feelings that do not correspond with the reality and is derived from questions regarding the hearing of unrealistic voices or sounds and having unrealistic thoughts and paranoid or anxious feelings. The external perception indicates a misperception of an external stimulus or change in the awareness of the subject's surroundings and is derived from questions regarding the change of body parts, the change of surroundings, the altered passing of time, the difficulty of controlling thoughts, and the change in color and sound intensity.
Measured: Time 0, 30, 90, 150, 210, 270, 330, 390 and 450 minutes after oxycodon or placebo administration.
Pain Pressure Threshold (mN);
We will use the FPN 100 N Algometer (FDN 100, Wagner Instruments Inc., Greenwich, CT, USA; Rolke et al., 2005) to deliver pressure pain on a skin area of 1 cm2 between thumb and index finger. The FDN 100 has a force capacity (± accuracy) of 100 ± 2 N (10 ± 0.2 kgf) and graduation of 1 N (100 gf), respectively. A gradually increasing pressure is manually applied and the subjects are asked to indicate when the procedure becomes painful (pressure pain threshold, PPTh).
Measured: Time 0, 25, 55, 90, 105, 125, 145, 205, 265, 270, 285, 305, 325, 385 and 445 minutes after oxycodon or placebo administration.
slope of the hypercapnic ventilatory response;
Slope
Measured: Time 0, 60, 120, 180, 240, 300, 360 and 420 minutes after oxycodon or placebo administration.
plasma concentrations of THC, 11-OH-THC and oxycodone; a secondary analysis will be performed on the pharmacokinetic and pharmacodynamic data (PKPD modeling).
Plasma concentration
Measured: Time 0, 30, 60, 95, 110, 130, 150, 210, 270, 275, 290, 310, 330, 390 and 450 minutes after oxycodon or placebo administration.
Bond & Lader questionnaire score
The Bond and Lader scales are calculated from sixteen 100 mm visual analog scales.
Measured: Time 0, 30, 90, 150, 210, 270, 330, 390 and 450 minutes after oxycodon or placebo administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start9 Dec 2021
- Primary completionDec 2022 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory DepressionStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double blind, randomized cross-over, placebo-controlled design.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Albert Dahan, Leiden University Medical Center
- Investigators
- Monique van Velzen, Phd, Principal investigator, LUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05235503
- Sponsor's protocol ID
- P21.030
- Other IDs
- 2021-000083-29, NL76443.058.21
- Acronym
- COXY
- Status last verified
- Feb 2022
- First submitted
- 30 Nov 2021
- Last updated
- 11 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Δ9-tetrahydrocannabinol (THC) on Oxycodone Induced Ventilatory Depression in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05235503
- Acronym / sponsor ID
- COXY / P21.030
- Conditions
- Respiratory Depression, Cannabis Use, Opioid Use
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 9 Dec 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 11 Feb 2022 (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.
Rationale:
Opioid misuse and abuse are common problems in the Western world. The rate of unintentional drug overdose is rapidly increasing, not only in the Unites States but also in the Netherlands. Additionally, it is well known that opioids are often used (and abused) in combination with other legal or illicit substances, for example cannabis, including medicinal (i.e. doctor prescribed) cannabis. A major opioid-induced adverse effect is respiratory depression and there are no data that show how oxycodone interacts with cannabis on the ventilatory control system. An appreciable effect is possible given the sedative effects of cannabis. Moreover, investigators previously showed that combining even a low dose of oxycodone (20 mg) with ethanol increased the likelihood of an apneic event (van der Schrier et al. Anesthesiology 2017; 102: 115-122). Because of this side effect and also due to the rising number of addicted chronic opioid users, there is an increasing imminent societal, political and medical interest in advancing research on opioids, opioid-drug interaction and alternatives for the treatment of various chronic illnesses and chronic pain.
Hypothesis: The investigators hypothesize that cannabis will amplify the ventilatory depressant effect of oxycodone (primary end-point).
Objective: The objective of the study is to quantify the interactive effect of Δ9-tetrahydrocannabinol (THC) and oxycodone on ventilatory control.
Study design: Double blind, randomized cross-over, placebo-controlled design.
Study population: Healthy human volunteers between the age of 18 and 45 years old.
Intervention:
Visit A: placebo capsule at t = 0 min + Bedrocan (22.4 mg THC) at t = 90 and 270 min; Visit B: oxycodone 20 mg at t = 0 min + Bedrocan (22.4 mg THC) at t = 90 and 270 min.
Main study parameters/endpoints:
Primary endpoint: The effect of inhaled THC on ventilation at an end-tidal PCO2 = 55 mmHg without and with concomitant intake of 20 mg oxycodone immediate release (IR) capsule in healthy volunteers 120 min after oxycodone intake.
Secondary endpoints: (1) Outcome of Bowdle and Bond \& Lader questionnaires; (2) Level of sedation; (3) Pain Pressure Threshold; (4) slope of the hypercapnic ventilatory response; (5) plasma concentrations of THC, 11-OH-THC and oxycodone; a secondary analysis will be performed on the pharmacokinetic and pharmacodynamic data (PKPD modeling).
Detailed description
General study design The design of the study is randomized, placebo-controlled crossover. Each subject will be studied twice, on one occasion he or she will receive THC and a placebo opioid capsule, and on the other occasion THC and an oxycodone capsule. The visits to the lab will be randomized, the washout period between the two occasions is at least 10 days. Subjects will be evaluated by a physician at screening and only healthy volunteers, aged 18-45 years, with a body mass index < 30 kg.m-2, are eligible to participate in the study.
Upon arrival in the laboratory (K5-120), the investigators will perform a urinary drug test and breath alcohol test. When these tests are positive, the subject is excluded from further participation. A venous and an arterial line will be placed. The venous line is used for fluid administration (NaCl/Glucose 50-100 ml/h), the arterial line is for blood sample drawing.
Next, the first hypercapnic ventilatory responses (HCVR) will be obtained (t = -30 min). This is the pre-drug baseline measurement. At t = 0, the subjects will receive 20 mg oxycodone immediate release or placebo. Next, the investigators will obtain HCVRs at 1-hour intervals until 6 hours after oxycodone/placebo intake. At t = 1.5 h and at t = 4.5 h the subject will inhale 100 mg Bedrocan. Breathing will be measured using the "dynamic end-tidal forcing" (DEF) system. At specific time points the investigators will draw 10 mL blood for measurement of drug concentrations. After 8 hours of measurement, we will assess whether the HCVR is still depressed. If so, the investigators will take another measurement at t = 9 h and reassess the HCVR. If still depressed, a last response will be obtained at t = 10 h. If necessary, the subject will stay overnight in the hospital. This will be decided by the physician-investigator. For example, the subject may still be sedated.
The hypercapnic ventilatory response To obtain the HCVR curve, the subject will rebreathe a gas mixture from a 6 L rebreathing balloon bag containing 7% carbon dioxide in 93% oxygen. The slope of the response and ventilation at 55 mmHg will be used in the analysis.
Oxycodone intake:
At t = 0, the subject will ingest 1 oxycodone 20 mg immediate release or a placebo capsule with 100 mL water. Both drugs will be obtained from the LUMC pharmacy.
Cannabis inhalation: Bedrocan is vaporized using the CE-marked Volcano Medic vaporizer (Storz \& Bickel GmbH \& Co, Tuttlingen, Germany), a safe and reliable method of intrapulmonary administration of cannabinoids. The Volcano heats the homogenized plant material to 210 °C to allow for conversion of the THC acid and CBD acid into THC and CBD vapor for inhalation. The complete 100 mg from the glass vial will be entered into the vaporizing chamber of the Volcano Medic. The vapor will be collected in a 6-L plastic balloon that, after inflation, is detached from the vaporizer and subsequently equipped with a mouthpiece for inhalation. It is our experience that the full content of the balloon is inhaled without any problems within 3-5 min.
The Bedrocan cannabis variety contains 22% THC (220 mg per gram) and less than 1%CBD. It is developed in the Netherlands out of a requirement by the Dutch Health Ministry to have a "high THC" variety available to patients. We will administer 100 mg Bedrocan that contains 22.4-mg THC and less than 1-mg CBD, twice. Bedrocan will be obtained via the Bureau voor Medicinale Cannabis (BMO), a governmental organization (VWS) that obtains cannabis from Bedrocan Int. BV in Veenendaal, The Netherlands.
Blood sampling Ten mL blood samples will be obtained on 14 occasions on each visit (total volume = 112 mL per visit) at t = 30 and 60 min after oxycodone intake and at t = 5, 20, 40, 60, 120, 180, 185, 200, 220, 240, 300 and 360 min after the first THC inhalation. From these sample, the following drugs will be measured: oxycodone, THC, THC's metabolite 11-OH-THC and cannabidiol (CBD). CBD is measured as it is expected that some minor quantities of CBD are present in Bedrocan.
Arterial blood will be collected in EDTA tubes. After blood collection the tubes will preferably be put in ice water in aluminum foiled containers, will be centrifuged within one hour for 10 minutes at 2000 G at 4 °C. The handling of samples will be done with the lights switched off. The plasma will be equally divided in 2 tubes (Brown Sarstedt) (primary and back-up sample). Plasma samples will be stored at a temperature of -80 °C and blood samples will be sent to Analytical Biochemical Laboratory (ABL) B.V., Assen, The Netherlands on dry-ice. Pharmacokinetic analysis will be performed using a validated assay. Determination of drug concentrations will be performed using liquid chromatography with tandem-mass spectrometer detection (LC-MS/MS). Analysis of the samples and acceptance criteria are indicated in ABL Standard Operating Procedure (SOP) 0251.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Double blind, randomized cross-over, placebo-controlled design.
| Arm | Type | Receives |
|---|---|---|
| 20mg Oxycodon (capsule) + 100 mg Bedrocan (vaporized) | Experimental | Drug: Medicinal cannabis in combination with oxycodonAs stated above |
| Placebo oxycodon (capsule) + 100 mg Bedrocan (vaporized) | Placebo comparator | Drug: Medicinal cannabis in combination with placebo oxycodonAs stated above |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- aged 18-45 years,
- body mass index < 30 kg.m-2,
- able to understand the written informed consent form,
- able to communicate with the staff,
- able and willing to complete the study procedures,
Key exclusion criteria (7 listed)
- Presence or history of any medical or psychiatric disease (incl. a history of substance abuse, anxiety, or the presence of a painful syndrome such as fibromyalgia);
- Use of any medication in the three months prior to the study (incl. paracetamol or other pain killers), except for oral contraceptives (females);
- Use of more than 21 alcohol units per week;
- Use of cannabis in the 4 weeks prior to the study;
- A positive urinary drug test or a breath alcohol test at screening or on the morning of the experiment;
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 |
|---|---|---|
| Medicinal cannabis in combination with oxycodonThe intervention will be administering the combination of medicinal cannabis in combination with oxycodon | Drug | 20mg Oxycodon (capsule) + 100 mg Bedrocan (vaporized) |
| Medicinal cannabis in combination with placebo oxycodonThe intervention will be administering the combination of medicinal cannabis in combination with placebo oxycodon | Drug | Placebo oxycodon (capsule) + 100 mg Bedrocan (vaporized) |
Primary outcome
The effect of inhaled THC on ventilation (Liters per minute) at an end-tidal PCO2 = 55 mmHG without and with concomitant intake of 20 mg oxycodone immediate release (IR) capsule in healthy volunteers 120 min after oxycodone intake.
Time frame: 120 minutes after oxycodone intake
As stated above
5 secondary outcomes
Bowdle questionnaire score;
Time frame: Time 0, 30, 90, 150, 210, 270, 330, 390 and 450 minutes after oxycodon or placebo administration.
Pain Pressure Threshold (mN);
Time frame: Time 0, 25, 55, 90, 105, 125, 145, 205, 265, 270, 285, 305, 325, 385 and 445 minutes after oxycodon or placebo administration.
slope of the hypercapnic ventilatory response;
Time frame: Time 0, 60, 120, 180, 240, 300, 360 and 420 minutes after oxycodon or placebo administration.
plasma concentrations of THC, 11-OH-THC and oxycodone; a secondary analysis will be performed on the pharmacokinetic and pharmacodynamic data (PKPD modeling).
Time frame: Time 0, 30, 60, 95, 110, 130, 150, 210, 270, 275, 290, 310, 330, 390 and 450 minutes after oxycodon or placebo administration.
Bond & Lader questionnaire score
Time frame: Time 0, 30, 90, 150, 210, 270, 330, 390 and 450 minutes after oxycodon or placebo administration.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2022.
- Individual participant dataSharing planned: No
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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.
Monique van Velzen, Phd principal investigator
LUMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Medicinal cannabis in combination with oxycodon in people with Respiratory Depression and Cannabis Use, run by Leiden University Medical Center at 1 site in Netherlands.
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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 11 Feb 2022. 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 Netherlands. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cornelis Jan CJ van Dam, MSc (+31715299797, c.j.van_dam@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of inhaled THC on ventilation (Liters per minute) at an end-tidal PCO2 = 55 mmHG without and with concomitant intake of 20 mg oxycodone immediate release (IR) capsule in healthy volunteers 120 min after oxycodone intake. (time frame: 120 minutes after oxycodone intake). 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 11 Feb 2022.