CannabisEarly Phase 1NCT07434895
Repeated CBD Administration and Cannabis Outcomes
A Early Phase 1 study testing Cannabidiol, Medium Dose, Cannabidiol, Higher Dose and Active Inhaled Cannabis in people with Cannabis and Abuse Liability, run by Hannah Harris at 1 site in United States.
Trial summary
This outpatient study examines how cannabidiol (CBD) affects the behavioral and pain-relieving effects of cannabis. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cannabis, Abuse Liability, Experimental Pain in Healthy Human Participants
- What is being tested?
- Cannabidiol, Medium Dose, Cannabidiol, Higher Dose and Active Inhaled Cannabis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2026to 1 Dec 2029
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- English-speaking, literate adults,
- Male or female,
- Between the ages of 18-55,
- Body Mass Index from 18.5-32.0 kg/m2,
- Not currently seeking treatment for cannabis or drug use,
- Able to provide written informed consent and perform all study procedures,
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- If female, a negative pregnancy test and use of an effective form of contraception during study participation (e.g., oral contraceptive, abstinence, barrier method),
- Negative urine drug test for drugs of abuse (other than cannabis) prior to every Laboratory Session, and
- Otherwise healthy as determined by the investigator based on medical history, physical examination, vital signs, and laboratory chemistries.
Who cannot join
- Physiologic drug dependence on opioids, benzodiazepines, barbiturates, and/or alcohol that would require medical management,
- Clinically significant acute medical problem (e.g., infection) or chronic medical problem requiring daily medication or ongoing medical care (e.g., hypertension, cardiovascular disease, diabetes, respiratory disorders [e.g., asthma, COPD]),
- Current or past history of major psychiatric disorder that would limit ability to participate in the study,
- Use of cannabis exclusively for medical reasons (no recreational use reported),
- Current, unrelenting chronic pain that prevents participation (i.e., unable to sit in chair for 8 hours),
- Currently using daily prescription medications to manage medical conditions or any drug that could interfere with the study, including potent CYP2C9, CYP3A4, or CYP2C19 inducers,
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- Clinically significant abnormal ECG (as determined by study physician/cardiologist),
- Clinically significant abnormal laboratory findings,
- History of seizure disorder,
- Clinically significant history of head injuries requiring medical management or long lasting sequalae, and
- Self-report of past 30-day use of synthetic cannabis (i.e., K2, Spice).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kentucky
Lexington, Kentucky, 40508
Paul A Nuzzo, M.A., 859-323-0002, pnuzz2@email.uky.edu
Hannah M Harris, Ph.D., hannah.harris@uky.edu
About this study
Official title: The Effects of Repeated CBD Administration on Cannabis Abuse Liability and Analgesia: A Human Laboratory Study
This outpatient study examines how cannabidiol (CBD) affects the behavioral and pain-relieving effects of cannabis.
- Being tested
- Cannabidiol, Medium Dose, Cannabidiol, Higher Dose, Active Inhaled Cannabis, Placebo Cannabidiol, Placebo Inhaled Cannabis
- Keywords
- marijuana, cannabidiol (CBD), marijuana users
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cannabidiol, Medium DoseDrug
Active Cannabidiol: Active cannabidiol (medium dose) will be administered orally for 14 days.
Cannabidiol, Higher DoseDrug
Description: Active Cannabidiol: Active cannabidiol (higher dose) will be administered orally for 14 days.
Active Inhaled CannabisDrug
Active Marijuana: Active Marijuana (active inhaled cannabis) will be administered through a vaporizer once per study session day (Day 1, 7, 14) per block (3 blocks total).
Placebo CannabidiolDrug
Inactive/Placebo Cannabidiol: Inactive/placebo cannabidiol will be administered orally for 14 days.
Placebo Inhaled CannabisDrug
Inactive/Placebo Marijuana: Experimental, non-therapeutic administration of an inactive/placebo marijuana dose will be administered through a vaporizer at each study session day (Days 1, 7, 14) per block (3 blocks total).
| Study group | Role | What they receive |
|---|---|---|
| Placebo CBD/Placebo Inhaled Cannabis | Placebo comparator | Participants will receive non-therapeutic, experimental doses of placebo/inactive cannabidiol in combination with non-therapeutic, placebo/inactive vaporized marijuana. Inactive cannabidiol and inactive marijuana will be administered once per session. It is possible to receive both inactive drugs on the same day.
Inactive/Placebo Cannabidiol: Placebo/inactive cannabidiol will be administered orally.
Inactive/Placebo: Experimental, non-therapeutic administration of an inactive/placebo marijuana dose will be administered through a vaporizer. Receives: Drug: Placebo Cannabidiol; Drug: Placebo Inhaled Cannabis |
| Placebo CBD/Active Inhaled Cannabis | Experimental | Participants will receive a non-therapeutic, experimental dose of inactive/placebo cannabidiol in combination with non-therapeutic, active vaporized marijuana. It is possible to receive inactive cannabidiol and active marijuana on the same day.
Inactive/Placebo Cannabidiol: Active cannabidiol will be administered orally.
Active Marijuana: Experimental, non-therapeutic administration of an active marijuana dose will be administered through a vaporizer. Receives: Drug: Active Inhaled Cannabis; Drug: Placebo Cannabidiol |
| CBD (Medium Dose)/Placebo Inhaled Cannabis | Experimental | Participants will receive a non-therapeutic, experimental dose of active cannabidiol in combination with non-therapeutic, inactive vaporized marijuana. It is possible to receive active cannabidiol, and inactive marijuana on the same day.
Active Cannabidiol: Active cannabidiol will be administered orally.
Inactive/Placebo Marijuana: Experimental, non-therapeutic administration of an inactive/placebo marijuana dose will be administered through a vaporizer. Receives: Drug: Cannabidiol, Medium Dose; Drug: Placebo Inhaled Cannabis |
| CBD (Medium Dose)/Active Inhaled Cannabis | Experimental | Participants will receive non-therapeutic, experimental doses of active cannabidiol in combination with non-therapeutic, experimental doses of active vaporized marijuana. Cannabidiol and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day.
Vaporized Marijuana: Active Marijuana administered through a vaporizer
Cannabidiol: Active cannabidiol will be administered orally Receives: Drug: Cannabidiol, Medium Dose; Drug: Active Inhaled Cannabis |
| CBD (Higher Dose)/Placebo Inhaled Cannabis | Experimental | Participants will receive a non-therapeutic, experimental dose of active cannabidiol in combination with non-therapeutic, inactive vaporized marijuana. It is possible to receive active cannabidiol, and inactive marijuana on the same day.
Active Cannabidiol: Active cannabidiol will be administered orally.
Inactive/Placebo Marijuana: Experimental, non-therapeutic administration of an inactive/placebo marijuana dose will be administered through a vaporizer. Receives: Drug: Cannabidiol, Higher Dose; Drug: Placebo Inhaled Cannabis |
| CBD (Higher Dose)/Active Inhaled Cannabis | Experimental | Participants will receive non-therapeutic, experimental doses of active cannabidiol in combination with a non-therapeutic, experimental dose of active vaporized marijuana. Active cannabidiol and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day.
Active Cannabidiol: Active cannabidiol will be administered orally.
Active Marijuana: Active Marijuana will be administered through a vaporizer. Receives: Drug: Cannabidiol, Higher Dose; Drug: Active Inhaled Cannabis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline-Subject-Related Outcome-VAS Drug Liking
Participants rated their subjective drug liking on a standardized VAS scale (0 to 100). These Scores will indicate how participants are feeling at that moment, including questions on mood, physical symptoms, and drug effects. Low scores mean little to no drug liking. Higher scores mean greater drug liking. Raw data transformed to peak scores.
Measured: Days 1 (baseline), 7, 14, prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).
Change from Baseline-Marijuana Purchase Task: Elasticity
Behavioral economic demand for cannabis: how much a participant values cannabis as its "price" (cost, effort, or availability) increases. Participants indicate how much marijuana they would buy and consume at increasing, hypothetical prices. This outcome describes how sensitive marijuana consumption is to price changes and how quickly demand decreases as marijuana becomes more expensive.
Measured: Days 1 (baseline), 7, 14, measured ~3 hours post cannabis administration.
Secondary outcomes (3)
Change from Baseline-Cold Pressor Test (CPT) Threshold
Participants first immerse a dominant hand into the warm-water bath for 2 minutes. The participants are then instructed to immerse the dominanat hand in the cold-water bath and report when pain is first experienced, and to keep the hand submerged as long as possible, and to withdraw the hand from the water when the sensation becomes uncomfortable. Latency (in seconds) to first pain sensations (threshold) will be measured and recorded.
Measured: Days 1 (baseline), 7, 14, This outcome will be recorded before and at two additional intervals after active and placebo cannabis administration during the laboratory session (a total of 6 measurements per session).
Change from Baseline-Cold Pressor Test (CPT) Tolerance
Participants first immerse a dominant hand into the warm-water bath for 2 minutes. The participants are then instructed to immerse the dominant hand in the cold-water bath and report when pain is first experienced, and to keep the hand submerged as long as possible, and to withdraw the hand from the water when the sensation becomes uncomfortable. Latency to withdrawal from the water (tolerance) will be measured and recorded.
Measured: Days 1 (baseline), 7, 14, This outcome will be recorded before and at two additional intervals after active and placebo cannabis administration during the laboratory session (a total of 6 measurements per session).
Change from Baseline-Cold Pressor Visual Analog Scale (CPT-VAS): Painful
Participants first immerse a dominant hand in the warm-water bath for 2 minutes. The participants are then instructed to immerse the dominant hand in the cold-water bath and report when pain is first experienced, and to keep the hand submerged as long as possible, and to withdraw the hand from the water when the sensation becomes uncomfortable. Participants will report how painful the pain was on a visual analog scale. Low scores mean little to no pain. Higher scores mean greater pain. Raw data transformed to peak scores.
Measured: Days 1 (baseline), 7, 14, This outcome will be recorded before and after the CPT for a total of 6 measurements per session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start5 Aug 2026
- Primary completion1 Dec 2029 (estimated)
- Study completion1 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CannabisStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hannah Harris
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor-investigator, Hannah Harris, University of Kentucky
- Investigators
- Hannah M Harris, Ph.D., Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07434895
- Sponsor's protocol ID
- 107878
- Other IDs
- K01DA056692
- Status last verified
- Aug 2026
- First submitted
- 19 Feb 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Repeated CBD Administration on Cannabis Abuse Liability and Analgesia: A Human Laboratory Study
- ClinicalTrials.gov ID
- NCT07434895
- Acronym / sponsor ID
- 107878
- Keywords
- marijuana, cannabidiol (CBD), marijuana users
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Hannah HarrisUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 5 Aug 2026 (actual)
- Primary completion
- 1 Dec 2029 (estimated)
- Study completion
- 1 Dec 2029 (estimated)
- First posted
- 27 Feb 2026 (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.
This outpatient study examines how cannabidiol (CBD) affects the behavioral and pain-relieving effects of cannabis.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Placebo CBD/Placebo Inhaled Cannabis | Placebo comparator | Drug: Placebo Cannabidiol, Drug: Placebo Inhaled CannabisParticipants will receive non-therapeutic, experimental doses of placebo/inactive cannabidiol in combination with non-therapeutic, placebo/inactive vaporized marijuana. Inactive cannabidiol and inactive marijuana will be administered once per session. It is possible to receive both inactive drugs on the same day. Inactive/Placebo Cannabidiol: Placebo/inactive cannabidiol will be administered orally. Inactive/Placebo: Experimental, non-therapeutic administration of an inactive/placebo marijuana dose will be administered through a vaporizer. |
| Placebo CBD/Active Inhaled Cannabis | Experimental | Drug: Active Inhaled Cannabis, Drug: Placebo CannabidiolParticipants will receive a non-therapeutic, experimental dose of inactive/placebo cannabidiol in combination with non-therapeutic, active vaporized marijuana. It is possible to receive inactive cannabidiol and active marijuana on the same day. Inactive/Placebo Cannabidiol: Active cannabidiol will be administered orally. Active Marijuana: Experimental, non-therapeutic administration of an active marijuana dose will be administered through a vaporizer. |
| CBD (Medium Dose)/Placebo Inhaled Cannabis | Experimental | Drug: Cannabidiol, Medium Dose, Drug: Placebo Inhaled CannabisParticipants will receive a non-therapeutic, experimental dose of active cannabidiol in combination with non-therapeutic, inactive vaporized marijuana. It is possible to receive active cannabidiol, and inactive marijuana on the same day. Active Cannabidiol: Active cannabidiol will be administered orally. Inactive/Placebo Marijuana: Experimental, non-therapeutic administration of an inactive/placebo marijuana dose will be administered through a vaporizer. |
| CBD (Medium Dose)/Active Inhaled Cannabis | Experimental | Drug: Cannabidiol, Medium Dose, Drug: Active Inhaled CannabisParticipants will receive non-therapeutic, experimental doses of active cannabidiol in combination with non-therapeutic, experimental doses of active vaporized marijuana. Cannabidiol and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Vaporized Marijuana: Active Marijuana administered through a vaporizer Cannabidiol: Active cannabidiol will be administered orally |
| CBD (Higher Dose)/Placebo Inhaled Cannabis | Experimental | Drug: Cannabidiol, Higher Dose, Drug: Placebo Inhaled CannabisParticipants will receive a non-therapeutic, experimental dose of active cannabidiol in combination with non-therapeutic, inactive vaporized marijuana. It is possible to receive active cannabidiol, and inactive marijuana on the same day. Active Cannabidiol: Active cannabidiol will be administered orally. Inactive/Placebo Marijuana: Experimental, non-therapeutic administration of an inactive/placebo marijuana dose will be administered through a vaporizer. |
| CBD (Higher Dose)/Active Inhaled Cannabis | Experimental | Drug: Cannabidiol, Higher Dose, Drug: Active Inhaled CannabisParticipants will receive non-therapeutic, experimental doses of active cannabidiol in combination with a non-therapeutic, experimental dose of active vaporized marijuana. Active cannabidiol and marijuana doses will be administered once during each session. It is possible to receive both active drugs on the same day. Active Cannabidiol: Active cannabidiol will be administered orally. Active Marijuana: Active Marijuana will be administered through a vaporizer. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- English-speaking, literate adults,
- Male or female,
- Between the ages of 18-55,
- Body Mass Index from 18.5-32.0 kg/m2,
- Not currently seeking treatment for cannabis or drug use,
Key exclusion criteria (11 listed)
- Physiologic drug dependence on opioids, benzodiazepines, barbiturates, and/or alcohol that would require medical management,
- Clinically significant acute medical problem (e.g., infection) or chronic medical problem requiring daily medication or ongoing medical care (e.g., hypertension, cardiovascular disease, diabetes, respiratory disorders [e.g., asthma, COPD]),
- Current or past history of major psychiatric disorder that would limit ability to participate in the study,
- Use of cannabis exclusively for medical reasons (no recreational use reported),
- Current, unrelenting chronic pain that prevents participation (i.e., unable to sit in chair for 8 hours),
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 |
|---|---|---|
| Cannabidiol, Medium DoseActive Cannabidiol: Active cannabidiol (medium dose) will be administered orally for 14 days. | Drug | CBD (Medium Dose)/Active Inhaled Cannabis, CBD (Medium Dose)/Placebo Inhaled Cannabis |
| Cannabidiol, Higher DoseDescription: Active Cannabidiol: Active cannabidiol (higher dose) will be administered orally for 14 days. | Drug | CBD (Higher Dose)/Active Inhaled Cannabis, CBD (Higher Dose)/Placebo Inhaled Cannabis |
| Active Inhaled CannabisActive Marijuana: Active Marijuana (active inhaled cannabis) will be administered through a vaporizer once per study session day (Day 1, 7, 14) per block (3 blocks total). | Drug | CBD (Higher Dose)/Active Inhaled Cannabis, CBD (Medium Dose)/Active Inhaled Cannabis, Placebo CBD/Active Inhaled Cannabis |
| Placebo CannabidiolInactive/Placebo Cannabidiol: Inactive/placebo cannabidiol will be administered orally for 14 days. | Drug | Placebo CBD/Active Inhaled Cannabis, Placebo CBD/Placebo Inhaled Cannabis |
| Placebo Inhaled CannabisInactive/Placebo Marijuana: Experimental, non-therapeutic administration of an inactive/placebo marijuana dose will be administered through a vaporizer at each study session day (Days 1, 7, 14) per block (3 blocks total). | Drug | CBD (Higher Dose)/Placebo Inhaled Cannabis, CBD (Medium Dose)/Placebo Inhaled Cannabis, Placebo CBD/Placebo Inhaled Cannabis |
Primary outcome
Change from Baseline-Subject-Related Outcome-VAS Drug Liking
Time frame: Days 1 (baseline), 7, 14, prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).
Participants rated their subjective drug liking on a standardized VAS scale (0 to 100). These Scores will indicate how participants are feeling at that moment, including questions on mood, physical symptoms, and drug effects. Low scores mean little to no drug liking. Higher scores mean greater drug liking. Raw data transformed to peak scores.
Change from Baseline-Marijuana Purchase Task: Elasticity
Time frame: Days 1 (baseline), 7, 14, measured ~3 hours post cannabis administration.
Behavioral economic demand for cannabis: how much a participant values cannabis as its "price" (cost, effort, or availability) increases. Participants indicate how much marijuana they would buy and consume at increasing, hypothetical prices. This outcome describes how sensitive marijuana consumption is to price changes and how quickly demand decreases as marijuana becomes more expensive.
3 secondary outcomes
Change from Baseline-Cold Pressor Test (CPT) Threshold
Time frame: Days 1 (baseline), 7, 14, This outcome will be recorded before and at two additional intervals after active and placebo cannabis administration during the laboratory session (a total of 6 measurements per session).
Change from Baseline-Cold Pressor Test (CPT) Tolerance
Time frame: Days 1 (baseline), 7, 14, This outcome will be recorded before and at two additional intervals after active and placebo cannabis administration during the laboratory session (a total of 6 measurements per session).
Change from Baseline-Cold Pressor Visual Analog Scale (CPT-VAS): Painful
Time frame: Days 1 (baseline), 7, 14, This outcome will be recorded before and after the CPT for a total of 6 measurements per session.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- 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.
Hannah M Harris, Ph.D. principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Cannabidiol, Medium Dose, Cannabidiol, Higher Dose and Active Inhaled Cannabis in people with Cannabis and Abuse Liability, run by Hannah Harris 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 9 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 12 Aug 2026. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paul A Nuzzo, M.A. (859-323-0002, pnuzz2@email.uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline-Subject-Related Outcome-VAS Drug Liking (time frame: Days 1 (baseline), 7, 14, prior to and in regular intervals after drug administration for the duration of the session (approx. 8 hours per session).). The study lists 2 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 12 Aug 2026.