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Within-subject test of blinded study medications for Cannabis

Phase 2
Waitlist Available
Led By Kelly E Dunn, PhD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 hour study session
Awards & highlights

Study Summary

This trial is testing whether combining two existing drugs can create an effective painkiller. It's the second in a series of such studies.

Eligible Conditions
  • Cannabis
  • Opioid Use Disorder
  • Pain

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 hour study session
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 hour study session for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Peak Cold Pressor Tolerance
Peak Number Accurate on Circular Lights
Peak Self-report Rating of "Drug Effect" (0-100), as Measured by the Visual Analog Rating Scale

Side effects data

From 2022 Phase 2 trial • 31 Patients • NCT04036968
32%
Drowsiness
16%
Dizziness
10%
Light Headed
6%
Nausea
3%
Dry Eyes
3%
Tingling
3%
Headache
3%
Shaky
3%
Euphoria
3%
Tremor
3%
Photosensitivity
3%
Restlessness
3%
Chills
3%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo+Placebo
Hydromorphone+Placebo
Hydromorphone (Oral) 4mg + Cannabidiol 50mg
Hydromorphone (Oral) 4mg + Cannabidiol 100mg
Hydromorphone (Oral) 4mg + Cannabidiol 200mg

Trial Design

5Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Hydromorphone (oral) 4mg + Cannabidiol 50mgExperimental Treatment1 Intervention
Within-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + cannabidiol (oral) 50mg. Order of dose randomized session days 2-5.
Group II: Hydromorphone (oral) 4mg + Cannabidiol 200mgExperimental Treatment1 Intervention
Within-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + cannabidiol (oral) 200mg. Order of dose randomized session days 2-5.
Group III: Hydromorphone (oral) 4mg + Cannabidiol 100mgExperimental Treatment1 Intervention
Within-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + cannabidiol (oral) 100mg. Order of dose randomized session days 2-5.
Group IV: Hydromorphone+PlaceboActive Control1 Intervention
Within-subject double-blind, double-dummy administration of hydromorphone (oral) 4mg + placebo. Always administered during session 1.
Group V: Placebo+PlaceboPlacebo Group1 Intervention
Within-subject double-blind, double-dummy administration of placebo + placebo. Order of dose randomized session days 2-5.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Within-subject test of blinded study medications
2020
Completed Phase 2
~60

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,464 Previous Clinical Trials
2,618,562 Total Patients Enrolled
20 Trials studying Cannabis
1,505 Patients Enrolled for Cannabis
Johns Hopkins UniversityLead Sponsor
2,256 Previous Clinical Trials
14,820,040 Total Patients Enrolled
7 Trials studying Cannabis
210 Patients Enrolled for Cannabis
Kelly E Dunn, PhDPrincipal InvestigatorJohns Hopkins University
1 Previous Clinical Trials
3 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Maryland
How old are they?
65+
What site did they apply to?
Johns Hopkins University Bayview Medical Campus
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Enhancing Medication-based Analgesia in Humans- STUDY 2
2020. "Enhancing Medication-based Analgesia in Humans- STUDY 2". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04036968.
~6 spots leftby Apr 2025
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