CannabisPhase 2NCT05563948
Repeated Administration of Cannabis Varying in THC and CBD
A Phase 2 study testing Cannabis in people with Cannabis, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
The majority of the >3 million medical cannabis patients in the U.S. use cannabis products to manage pain but many questions remain. This project is designed to answer three questions that will fill important voids in the field's understanding of sustained cannabis use: 1) is abrupt cessation of cannabis associated… Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cannabis
- What is being tested?
- Cannabis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2026to 30 Sep 2034
- Phase
- Phase 2
- 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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males or females, 21-65 years old
- For females: not pregnant or breast-feeding, and uses an acceptable form of birth control (e.g., condoms, IUD)
- Uses cannabis on a near-daily basis
- Not seeking treatment for cannabis use
- Able to provide informed consent
- Able to perform study procedures
Who cannot join
- Meets DSM-V criteria for any Substance Use Disorder other than cannabis, nicotine or caffeine
- Uses other illicit drugs ≥1 day/week in the prior 4 weeks
- Medical history, physical, psychiatric examination, or significant illness at the clinical discretion of the study physician; for example, history of heart disease, diabetes, hypertension (BP > 140/90) or uncontrolled asthma
- 5. Use of any prescription or daily use of over-the-counter medications 6. Recurrent, ongoing pain 7. Insensitivity to the thermal stimuli of the Cold Pressor Test or Quantitative Sensory Testing 8. History of physical violence or paranoia during cannabis withdrawal
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: Repeated Administration of Cannabis Varying in THC and CBD: Effects on Abuse Liability, Experimental Pain and Plasma Endocannabinoids
The majority of the >3 million medical cannabis patients in the U.S. use cannabis products to manage pain but many questions remain. This project is designed to answer three questions that will fill important voids in the field's understanding of sustained cannabis use: 1) is abrupt cessation of cannabis associated with increased pain sensitivity; 2) does tolerance develop to the analgesic and abuse-related effects of repeatedly administered cannabis with varying ratios of THC and CBD, and is this tolerance reversible following a period of abstinence; 3) how does repeated cannabis use affect levels of endocannabinoids, and are these changes associated with changes in pain sensitivity and abuse liability? In this study, the investigators will enroll participants (N=100 healthy, cannabis-using men and non-pregnant women, ages 21-65) inpatient for 15 days. They will be randomized to one of four cannabis conditions (n=25/group). Following a day of standardization on which participants will receive their assigned cannabis condition (Day 1), cannabis will be administered repeatedly for 14 days (Day 2-15). The investigators will measure abuse-related effects ("Good Drug Effect"), endocannabinoid levels and two distinct types of experimental pain: The Cold Pressor Test and Quantitative Sensory Testing Thermal Temporal Summation. Given the widespread use of cannabis for pain, understanding the consequences of daily repeated administration of cannabis with THC:CBD ratios that are representative of most medical cannabis products on pain, abuse liability, and endocannabinoids is imperative.
- Conditions
- Cannabis
- Being tested
- Cannabis
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabisDrug
Vaporized cannabis will be administered 3x/day for 15 days.
| Study group | Role | What they receive |
|---|---|---|
| High THC : High CBD | Experimental | Cannabis that is high in THC and high in CBD will be administered. Receives: Drug: Cannabis |
| High THC : Low CBD | Experimental | Cannabis that is high in THC and low in CBD will be administered. Receives: Drug: Cannabis |
| Low THC : High CBD | Experimental | Cannabis that is low in THC and high in CBD will be administered. Receives: Drug: Cannabis |
| Low THC : Low CBD | Placebo comparator | Cannabis that is low in THC and low in CBD will be administered. Receives: Drug: Cannabis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cold Pressor Test (Change over time from baseline)
The Cold Pressor Test (CPT) is a validated and reliable pain-induction procedure that reflects A-delta nerve fiber activity within the autonomic nervous system and closely mimics clinical chronic pain. CPT has been shown to have excellent reliability and predictive validity for medication-induced analgesia, including cannabinoids. For this task, two temperature-controlled circulating water baths maintain warm (36.5-37.5ºC) and cold (3.5-4.5ºC) water. Participants immerse their hand into a warm bath for 3 min (to standardize baseline skin temperature), then the cold bath, indicating when they first experience pain and withdrawing when the pain gets uncomfortable. Study staff will record time (in seconds) until participants: 1) report discomfort (pain threshold), and 2) withdraw their hand from the cold water (pain tolerance).
Measured: 8x/day on Days 1, 2, 5, 8, 9, 12, 15.
Quantitative Sensory Testing-Thermal Temporal Summation (QST-TTS; change over time from baseline)
(QST-TTS) uses repetitive fixed frequency and intensity heat stimulation to induce central sensitization of C-fibers in the spinal cord and is regarded as an experimental correlate of the 'wind-up' phenomenon in the dorsal horn. As dorsal horn CB-1 activity has been linked to suppression of 'wind-up' and central sensitization (the mechanism purportedly underlying cannabis' efficacy for neuropathic pain), cannabis use may decrease QST-TTS response, mirroring analgesia on the CPT during active cannabis administration vs. placebo. For this task, a Medoc TSA-II NeuroSensory Analyzer with a 30 x 30 mm Peltier thermode applies tonic noxious heat stimulation to the thenar eminence of the palm: the baseline temperature is 32.0°C, increases at a rate of 1°C/s up to 46.5°C, and remains constant for 120 sec. Total duration.
Measured: 8x/day on Days 1, 2, 5, 8, 9, 12, 15.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2022
- Study start1 Oct 2026 (estimated)
- Primary completion30 Sep 2032 (estimated)
- Study completion30 Sep 2034 (estimated)
Why it stopped: In response to quality assurance and compliance concerns, OHRP issued an FWA restriction on NYSPI research that included a pause of human research as of June 23, 2023.
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
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margaret Haney, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05563948
- Sponsor's protocol ID
- 8347
- Status last verified
- Aug 2026
- First submitted
- 26 Sep 2022
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeated Administration of Cannabis Varying in THC and CBD: Effects on Abuse Liability, Experimental Pain and Plasma Endocannabinoids
- ClinicalTrials.gov ID
- NCT05563948
- Acronym / sponsor ID
- 8347
- Conditions
- Cannabis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: In response to quality assurance and compliance concerns, OHRP issued an FWA restriction on NYSPI research that included a pause of human research as of June 23, 2023.
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 30 Sep 2032 (estimated)
- Study completion
- 30 Sep 2034 (estimated)
- First posted
- 3 Oct 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.
The majority of the >3 million medical cannabis patients in the U.S. use cannabis products to manage pain but many questions remain. This project is designed to answer three questions that will fill important voids in the field's understanding of sustained cannabis use: 1) is abrupt cessation of cannabis associated with increased pain sensitivity; 2) does tolerance develop to the analgesic and abuse-related effects of repeatedly administered cannabis with varying ratios of THC and CBD, and is this tolerance reversible following a period of abstinence; 3) how does repeated cannabis use affect levels of endocannabinoids, and are these changes associated with changes in pain sensitivity and abuse liability? In this study, the investigators will enroll participants (N=100 healthy, cannabis-using men and non-pregnant women, ages 21-65) inpatient for 15 days. They will be randomized to one of four cannabis conditions (n=25/group). Following a day of standardization on which participants will receive their assigned cannabis condition (Day 1), cannabis will be administered repeatedly for 14 days (Day 2-15). The investigators will measure abuse-related effects ("Good Drug Effect"), endocannabinoid levels and two distinct types of experimental pain: The Cold Pressor Test and Quantitative Sensory Testing Thermal Temporal Summation. Given the widespread use of cannabis for pain, understanding the consequences of daily repeated administration of cannabis with THC:CBD ratios that are representative of most medical cannabis products on pain, abuse liability, and endocannabinoids is imperative.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| High THC : High CBD | Experimental | Drug: CannabisCannabis that is high in THC and high in CBD will be administered. |
| High THC : Low CBD | Experimental | Drug: CannabisCannabis that is high in THC and low in CBD will be administered. |
| Low THC : High CBD | Experimental | Drug: CannabisCannabis that is low in THC and high in CBD will be administered. |
| Low THC : Low CBD | Placebo comparator | Drug: CannabisCannabis that is low in THC and low in CBD will be administered. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males or females, 21-65 years old
- For females: not pregnant or breast-feeding, and uses an acceptable form of birth control (e.g., condoms, IUD)
- Uses cannabis on a near-daily basis
- Not seeking treatment for cannabis use
- Able to provide informed consent
Key exclusion criteria (4 listed)
- Meets DSM-V criteria for any Substance Use Disorder other than cannabis, nicotine or caffeine
- Uses other illicit drugs ≥1 day/week in the prior 4 weeks
- Medical history, physical, psychiatric examination, or significant illness at the clinical discretion of the study physician; for example, history of heart disease, diabetes, hypertension (BP > 140/90) or uncontrolled asthma
- 5. Use of any prescription or daily use of over-the-counter medications 6. Recurrent, ongoing pain 7. Insensitivity to the thermal stimuli of the Cold Pressor Test or Quantitative Sensory Testing 8. History of physical violence or paranoia during cannabis withdrawal
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 |
|---|---|---|
| CannabisVaporized cannabis will be administered 3x/day for 15 days. | Drug | High THC : High CBD, High THC : Low CBD, Low THC : High CBD, Low THC : Low CBD |
Primary outcome
Cold Pressor Test (Change over time from baseline)
Time frame: 8x/day on Days 1, 2, 5, 8, 9, 12, 15.
The Cold Pressor Test (CPT) is a validated and reliable pain-induction procedure that reflects A-delta nerve fiber activity within the autonomic nervous system and closely mimics clinical chronic pain. CPT has been shown to have excellent reliability and predictive validity for medication-induced analgesia, including cannabinoids. For this task, two temperature-controlled circulating water baths maintain warm (36.5-37.5ºC) and cold (3.5-4.5ºC) water. Participants immerse their hand into a warm bath for 3 min (to standardize baseline skin temperature), then the cold bath, indicating when they first experience pain and withdrawing when the pain gets uncomfortable. Study staff will record time (in seconds) until participants: 1) report discomfort (pain threshold), and 2) withdraw their hand from the cold water (pain tolerance).
Quantitative Sensory Testing-Thermal Temporal Summation (QST-TTS; change over time from baseline)
Time frame: 8x/day on Days 1, 2, 5, 8, 9, 12, 15.
(QST-TTS) uses repetitive fixed frequency and intensity heat stimulation to induce central sensitization of C-fibers in the spinal cord and is regarded as an experimental correlate of the 'wind-up' phenomenon in the dorsal horn. As dorsal horn CB-1 activity has been linked to suppression of 'wind-up' and central sensitization (the mechanism purportedly underlying cannabis' efficacy for neuropathic pain), cannabis use may decrease QST-TTS response, mirroring analgesia on the CPT during active cannabis administration vs. placebo. For this task, a Medoc TSA-II NeuroSensory Analyzer with a 30 x 30 mm Peltier thermode applies tonic noxious heat stimulation to the thenar eminence of the palm: the baseline temperature is 32.0°C, increases at a rate of 1°C/s up to 46.5°C, and remains constant for 120 sec. Total duration.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cannabis in people with Cannabis, run by New York State Psychiatric Institute 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 6 inclusion and 4 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: paused, as of the sponsor's last update on 1 Sep 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?
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?
Results are not available in the source record.
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?
Cold Pressor Test (Change over time from baseline) (time frame: 8x/day on Days 1, 2, 5, 8, 9, 12, 15.). 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 1 Sep 2026.