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PainPhase 2NCT04036968

Enhancing Medication-based Analgesia in Humans- STUDY 2

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a single-group, within-subject, double-blind, double-dummy, placebo and active-controlled study evaluated whether the FDA-approved cannabinoid cannabidiol (CBD; Epidiolex) 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
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
31 participants
Where
1 siteUnited States
Study dates
1 Feb 2020to 1 Nov 2022
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 or cannabinoid use in the past 7 days
Show all 14Show 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
  • ALT or AST levels >3x ULN and/or Bilirubin levels >2x ULN during Screening
  • Current (past 60-day) suicidal thoughts or past year history of suicidal behavior
  • Taking medications contraindicated with hydromorphone or cannabidiol
  • 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.

United States1 site

  • Johns Hopkins University Bayview Medical Campus

    Baltimore, Maryland, 21224

Other trials in United States

About this study

Official title: Evaluating Cannabidiol (CBD) 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 cannabidiol (CBD; Epidiolex) would enhance analgesia, subjective reports, and cognitive performance when compared to the FDA-approved opioid hydromorphone (Dilaudid). This is study 2 is a series of studies.

Read the detailed description

This was a human laboratory systematic examination of whether adding the FDA-approved cannabinoid cannabidiol (CBD; Epidiolex; 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.

Being tested
Within-subject test of blinded study medications
Keywords
Clinical Trial, Analgesia, Phase II, 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 groups in NCT04036968
Study groupRoleWhat they receive
Placebo+PlaceboPlacebo comparatorWithin-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+PlaceboActive comparatorWithin-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 + Cannabidiol 50mgExperimentalWithin-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + cannabidiol (oral) 50mg. Order of dose randomized session days 2-5.
Receives: Drug: Within-subject test of blinded study medications
Hydromorphone (oral) 4mg + Cannabidiol 100mgExperimentalWithin-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + cannabidiol (oral) 100mg. Order of dose randomized session days 2-5.
Receives: Drug: Within-subject test of blinded study medications
Hydromorphone (oral) 4mg + Cannabidiol 200mgExperimentalWithin-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + cannabidiol (oral) 200mg. Order of dose randomized session days 2-5.
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.

  1. Peak Cold Pressor Tolerance

    Peak amount of time participant submerged hand in cold pressor (5 degree circulating cold water) laboratory test of pain as a function of double- blinded study medications (range 0 -300).

    Measured: 8 hour study session

  2. Peak Self-report Rating of "Drug Effect" (0-100), as Measured by the Visual Analog Rating Scale

    Peak self-report rating of "Drug Effect" on a 0 ("none at all") to 100 ("extremely") visual analog scale as a function of double- blinded study medication, wherein higher values indicate stronger subjectively-experienced drug effects.

    Measured: 8 hour study session

  3. Peak Number Accurate on Circular Lights

    Peak number accuracy on the Circular Lights fine motor task as a function of double-blinded study drug administration. Participants were provided 60 seconds to press buttons that are lit in randomized order and displayed automatically on a circular lights wall mounted unit. The primary outcome is the number of lit buttons that were accurately pressed within 60 seconds, which is a metric to assess fine motor impairment. Lower numbers are indicative of greater drug-related impairment. There is no upper limit on the circular lights task.

    Measured: 8 hour study session

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2019
  2. Study start1 Feb 2020
  3. Primary completion1 Nov 2022
  4. Study completion1 Nov 2022

Resources

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
Within-subject study
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
31 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04036968
Sponsor's protocol ID
IRB00214289
Other IDs
R01DA040644
Status last verified
Dec 2023
First submitted
25 Jul 2019
Last updated
19 Dec 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bergeria CL, Mun CJ, Speed TJ, Huhn AS, Wolinsky D, Vandrey R, Campbell CM, Dunn KE. A within-subject, double-blind, placebo-controlled randomized evaluation of the combined effects of cannabidiol and hydromorphone in a human laboratory pain model. Pain. 2025 Feb 28;166(9):e175-e184. doi: 10.1097/j.pain.0000000000003561.

    PubMed 40839659

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 14 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 19 Dec 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 19 Dec 2023). 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?

Peak Cold Pressor Tolerance (time frame: 8 hour study session). 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?

On the ClinicalTrials.gov record for NCT04036968, which also lists 1 linked publication.

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 19 Dec 2023.

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