PainPhase 2NCT02901275
Enhancing Medication-based Analgesia in Humans
A Phase 2 study testing Within-subject test of blinded study medications in people with Pain and Cannabis, run by Johns Hopkins University at 1 site in United States.
Trial summary
This is a single-group, within-subject, double-blind, double-dummy, placebo and active-controlled study evaluated whether the FDA-approved cannabinoid dronabinol (Marinol) would enhance analgesia, subjective reports, and cognitive performance when compared to the FDA-approved opioid hydromorphone (Dilaudid). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Cannabis, Opioid Use, Unspecified
- What is being tested?
- Within-subject test of blinded study medications
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to 23 Mar 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18-75
- Urine sample tests negative for common illicit substances of abuse, including cannabis
- Medically cleared to take study medications
- Are not pregnant or breast feeding
- Willing to comply with the study protocol.
Who cannot join
- Meet DSM-5 criteria for alcohol/substance use disorder
- Taking opioids for pain
- Previous adverse reaction to a cannabinoid product
- Prescribed and taking stimulants or benzodiazepines
- Answer "yes" to item 1 of the Brief Pain Inventory indicating chronic pain
- Self-report any illicit drug use in the past 7 days
Show all 12Show fewer
- Presence of any clinically significant medical/psychiatric illness judged by the investigators to put subject at elevated risk for experiencing an adverse event
- History of seizure disorder
- Have a known allergy to the study medications or sesame seed oil
- Taking medications contraindicated with hydromorphone or dronabinol
- Have a history of clinically significant cardiac arrhythmias or vasopastic disease
- Have an abnormal and clinically-significant ECG
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Using Dronabinol to Enhance the Analgesic Effect of Hydromorphone in Humans
This is a single-group, within-subject, double-blind, double-dummy, placebo and active-controlled study evaluated whether the FDA-approved cannabinoid dronabinol (Marinol) would enhance analgesia, subjective reports, and cognitive performance when compared to the FDA-approved opioid hydromorphone (Dilaudid).
Read the detailed description
This was a human laboratory systematic examination of whether adding the FDA-approved cannabinoid dronabinol (Marinol; oral) to the FDA-approved opioid hydromorphone (Dilaudid; oral) would change the experience of hydromorphone as rated by laboratory measures of pain, subjective reports of drug effects, and cognitive performance. Subjects are healthy individuals with no history of drug use disorder. Study subjects and staff were completed blinded to the study drugs and the class of drugs under investigation and were informed that subjects may receive opioids, stimulants, cannabinoids, benzodiazepines, over the counter medications, and/or placebo. All participants completed all sessions. Sessions lasted up to 8-hours and were conducted at least 7 days apart on an outpatient basis. Primary outcomes were collected from participants prior to dosing and at several hour periods post-dosing.
- Conditions
- Pain, Cannabis, Opioid Use, Unspecified
- Being tested
- Within-subject test of blinded study medications
- Keywords
- Clinical Trial, Phase II, Analgesia, Abuse Potential
- Medical subject headings
- Pain, Marijuana Abuse, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Within-subject test of blinded study medicationsDrug
Within-subject double-blind, double-dummy, study design wherein all participants received all doses in 8-hour outpatient sessions. Primary outcomes assessed during 8-hour outpatient sessions and included laboratory pain testing, subjective reports of drug effects, and cognitive performance, evaluated as a function of study medication condition.
| Study group | Role | What they receive |
|---|---|---|
| Placebo + Placebo | Placebo comparator | Within-subject double-blind, double-dummy administration of placebo + placebo. Order of dose randomized session days 2-5. Receives: Drug: Within-subject test of blinded study medications |
| Hydromorphone (oral) 4mg + Placebo | Active comparator | Within-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + placebo. Always administered during session 1. Receives: Drug: Within-subject test of blinded study medications |
| Hydromorphone (oral) 4mg / Dronabinol (oral) 2.5mg | Experimental | Within-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + dronabinol (oral) 2.5mg. Order of dose randomized session days 2-5. Receives: Drug: Within-subject test of blinded study medications |
| Hydromorphone (oral) 4mg / Dronabinol (oral) 5mg | Experimental | Within-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + dronabinol (oral) 5.0mg. Order of dose randomized session days 2-5. Receives: Drug: Within-subject test of blinded study medications |
| Hydromorphone (oral) 4mg / Dronabinol (oral) 10mg | Experimental | Within-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + dronabinol (oral) 10mg. Order of dose randomized session days 2-5 but was never the first hydromorphone 4mg + dronabinol combination dose. Receives: Drug: Within-subject test of blinded study medications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change From Baseline in Seconds to Withdraw Hand From Cold Pressor Laboratory Pain Task
Compare study conditions in seconds to withdraw hand from cold pressor laboratory pain task, where longer time periods reflect higher tolerance to pain.
Measured: Baseline and time of hand withdrawal from cold pressor, up to 60 seconds
Mean Peak Rating of "Drug Effect" (0-100) as Measured by the Visual Analog Rating Scale
Mean peak of Visual Analog Scale ratings of Drug Effect (0-100) compared across each study condition, with higher ratings reflecting stronger drug effects.
Measured: 8-hour study session
Mean Change From Baseline in Maximum Percent Correct on Digit Symbol Substitution Test of Cognitive Behavior
Within-subject comparison of study conditions on the Digit Symbol Substitution Test (DSST), a measure of cognitive performance that is sensitive to drug effects, wherein lower percent scores reflect worse performance and suggest greater drug-related impairment.
Measured: Baseline and 8-hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2016 (estimated)
- Study startDec 2016
- Primary completion23 Mar 2020
- Study completion23 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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 2
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Each participant completed each of the 5 study conditions (identified here as arms).
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kelly Dunn, PhD, Principal investigator, Principal InvestigatorClaudia Campbell, PhD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02901275
- Sponsor's protocol ID
- IRB00097937
- Status last verified
- Nov 2023
- First submitted
- 28 Jul 2016
- Last updated
- 7 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Dronabinol to Enhance the Analgesic Effect of Hydromorphone in Humans
- ClinicalTrials.gov ID
- NCT02901275
- Acronym / sponsor ID
- IRB00097937
- Conditions
- Pain, Cannabis, Opioid Use, Unspecified
- Keywords
- Clinical Trial, Phase II, Analgesia, Abuse Potential
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- 23 Mar 2020 (actual)
- Study completion
- 23 Mar 2020 (actual)
- First posted
- 15 Sep 2016 (estimated)
- Results
- Posted 7 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-group, within-subject, double-blind, double-dummy, placebo and active-controlled study evaluated whether the FDA-approved cannabinoid dronabinol (Marinol) would enhance analgesia, subjective reports, and cognitive performance when compared to the FDA-approved opioid hydromorphone (Dilaudid).
Detailed description
This was a human laboratory systematic examination of whether adding the FDA-approved cannabinoid dronabinol (Marinol; oral) to the FDA-approved opioid hydromorphone (Dilaudid; oral) would change the experience of hydromorphone as rated by laboratory measures of pain, subjective reports of drug effects, and cognitive performance. Subjects are healthy individuals with no history of drug use disorder. Study subjects and staff were completed blinded to the study drugs and the class of drugs under investigation and were informed that subjects may receive opioids, stimulants, cannabinoids, benzodiazepines, over the counter medications, and/or placebo. All participants completed all sessions. Sessions lasted up to 8-hours and were conducted at least 7 days apart on an outpatient basis. Primary outcomes were collected from participants prior to dosing and at several hour periods post-dosing.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
- Model description
- Each participant completed each of the 5 study conditions (identified here as arms).
| Arm | Type | Receives |
|---|---|---|
| Placebo + Placebo | Placebo comparator | Drug: Within-subject test of blinded study medicationsWithin-subject double-blind, double-dummy administration of placebo + placebo. Order of dose randomized session days 2-5. |
| Hydromorphone (oral) 4mg + Placebo | Active comparator | Drug: Within-subject test of blinded study medicationsWithin-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + placebo. Always administered during session 1. |
| Hydromorphone (oral) 4mg / Dronabinol (oral) 2.5mg | Experimental | Drug: Within-subject test of blinded study medicationsWithin-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + dronabinol (oral) 2.5mg. Order of dose randomized session days 2-5. |
| Hydromorphone (oral) 4mg / Dronabinol (oral) 5mg | Experimental | Drug: Within-subject test of blinded study medicationsWithin-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + dronabinol (oral) 5.0mg. Order of dose randomized session days 2-5. |
| Hydromorphone (oral) 4mg / Dronabinol (oral) 10mg | Experimental | Drug: Within-subject test of blinded study medicationsWithin-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + dronabinol (oral) 10mg. Order of dose randomized session days 2-5 but was never the first hydromorphone 4mg + dronabinol combination dose. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18-75
- Urine sample tests negative for common illicit substances of abuse, including cannabis
- Medically cleared to take study medications
- Are not pregnant or breast feeding
- Willing to comply with the study protocol.
Key exclusion criteria (12 listed)
- Meet DSM-5 criteria for alcohol/substance use disorder
- Taking opioids for pain
- Previous adverse reaction to a cannabinoid product
- Prescribed and taking stimulants or benzodiazepines
- Answer "yes" to item 1 of the Brief Pain Inventory indicating chronic pain
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 |
|---|---|---|
| Within-subject test of blinded study medicationsWithin-subject double-blind, double-dummy, study design wherein all participants received all doses in 8-hour outpatient sessions. Primary outcomes assessed during 8-hour outpatient sessions and included laboratory pain testing, subjective reports of drug effects, and cognitive performance, evaluated as a function of study medication condition. | Drug | Hydromorphone (oral) 4mg + Placebo, Hydromorphone (oral) 4mg / Dronabinol (oral) 10mg, Hydromorphone (oral) 4mg / Dronabinol (oral) 2.5mg, Hydromorphone (oral) 4mg / Dronabinol (oral) 5mg, Placebo + Placebo |
Primary outcome
Mean Change From Baseline in Seconds to Withdraw Hand From Cold Pressor Laboratory Pain Task
Time frame: Baseline and time of hand withdrawal from cold pressor, up to 60 seconds
Compare study conditions in seconds to withdraw hand from cold pressor laboratory pain task, where longer time periods reflect higher tolerance to pain.
Mean Peak Rating of "Drug Effect" (0-100) as Measured by the Visual Analog Rating Scale
Time frame: 8-hour study session
Mean peak of Visual Analog Scale ratings of Drug Effect (0-100) compared across each study condition, with higher ratings reflecting stronger drug effects.
Mean Change From Baseline in Maximum Percent Correct on Digit Symbol Substitution Test of Cognitive Behavior
Time frame: Baseline and 8-hours
Within-subject comparison of study conditions on the Digit Symbol Substitution Test (DSST), a measure of cognitive performance that is sensitive to drug effects, wherein lower percent scores reflect worse performance and suggest greater drug-related impairment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Kelly Dunn, PhD principal investigator
Principal Investigator
Claudia Campbell, PhD principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Within-subject test of blinded study medications in people with Pain and Cannabis, run by Johns Hopkins University at 1 site in United States.
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 5 inclusion and 12 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 7 Nov 2023. 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 United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Change From Baseline in Seconds to Withdraw Hand From Cold Pressor Laboratory Pain Task (time frame: Baseline and time of hand withdrawal from cold pressor, up to 60 seconds). The study lists 3 primary outcomes in all. 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 7 Nov 2023.