A Phase 2 interventional study of Active Cannabis and Placebo Cannabis in Cannabis, Pain and Tolerance, sponsored by New York State Psychiatric Institute. Completed at 1 site in United States. Open to participants aged 21 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-08.
Sponsored by New York State Psychiatric Institute · Phase 2, Interventional, and Basic science
Chronic pain is a significant public health concern in the U.S., for which prescription opioids have historically been the standard treatment. This has resulted in striking rates of opioid use disorders and fatal overdoses. Identifying non-opioid medications for the management of chronic pain with minimal abuse liability is a public health necessity, and cannabinoids are a promising drug class for this purpose. More than 80% of medicinal cannabis users report pain as their primary medical indication. These patients tend to seek products that are low in delta-9-tetrahydrocannabinol (THC; the primary psychoactive, and thus intoxicating, component of cannabis), and high in cannabidiol (CBD), a cannabinoid that purportedly has therapeutic benefit for pain but does not produce intoxicating effects. However, there are few well-controlled human laboratory studies assessing the efficacy of high-CBD cannabis for pain in the context of abuse, and even less is known regarding the effects of daily repeated use of cannabis on pain and its relationship to abuse liability.
The proposed randomized, within-subjects, placebo-controlled 16-day crossover inpatient human laboratory pilot study (N = 16 healthy cannabis users; 8 men, 8 women) will address important gaps in our understanding of the potential therapeutic utility of cannabis for pain: 1) If repeated cannabis use can result in hyperalgesia; 2) If tolerance to the analgesic and abuse-related effects of cannabis develops and is reversible. Two distinct modalities of experimental pain will be assessed: The Cold Pressor Test (CPT) and Quantitative Sensory Testing Thermal Temporal Summation (QST-TTS), and participants will smoke cannabis 3x/day. Throughout the study, experimental pain and abuse-related effects will be assessed, as will sleep and subjective mood assessments.
This protocol is currently suspended due to the NYSPI human subjects research pause and results cannot currently be analyzed and posted. Upon un-suspension, we will analyze the data and post results immediately.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's enrollment of 10 is below the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →New York State Psychiatric Institute is the lead sponsor of 435 studies on the registry; 27 are open to participants now.
Of its 51 completed or terminated interventional studies of FDA-regulated products, 45 (88%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
On the first full inpatient day (Day 1), participants will smoke one specified strength (Dose A; 75% of active cannabis cigarette, 2.98% THC, 4.91% CBD) of cannabis.
Drug: Active Cannabis
Days 2-8 comprises the Placebo phase, in which a second strength (Dose B; 75% of one placebo cannabis cigarette, \<0.01% THC, CBD) of cannabis will be administered 3x/day.
Drug: Placebo Cannabis
Days 9-15 comprise the Active Phase, cannabis Dose A (75% of one active cannabis cigarette, 2.98% THC, 4.91% CBD) will be administered once again, 3x/day.
Drug: Active Cannabis
2.98% THC:4.91% CBD cannabis.
\<0.01% THC:CBD cannabis.
Change in Cold Pressor Test (CPT) Latency
The CPT apparatus consists of two refrigerated circulators, filled with warm (36.5-37.5°C). participants will complete the CPT 30 minutes before the 1000h cannabis administration (baseline), and 15, 30, 45, 60, and 90 minutes post-cannabis administration. and cold (3.5 - 4.5°C) water. Participants will insert their non-dominant hand into the warm water and remove it after 3 minutes; skin temperature of the thumb pad will be measured. Participants will then insert their hand in the cold water and will be instructed to report when they first experience pain (pain threshold) and remove their hand when the cold water can no longer be tolerated (pain tolerance). Maximum immersion time will be 3 minutes. Data points reported here represent Percent Change in Pain Tolerance from Day 1 (first timepoint, 15 minutes post-cannabis \[2.98% THC / 4.91% CBD\]) across study days (Day 2, 5, 8, 9, 12, and 15). Other timepoints are not reported.
Time frame: Up to 15 days
Change in Cannabis Rating Form (CRF) Ratings
Participants rate the "high" experienced as a result of cannabis administration on a 100mm visual analog scale. Data points represent Percent Change from Day 1 (first timepoint, 15 minutes post-cannabis \[2.98% THC / 4.91% CBD\]) across study days (Day 2, 5, 8, 9, 12, and 15) Repeats at days 1, 2, 5, 8, 9, 12, and 15.
Time frame: Up to 15 days
Participants were recruited between June 2021 and June 2023. Eligible participants were recruited from the New York, NY area and occurred through advertisements in local newspapers, online through Craigslist, RecruitMe, and by word of mouth.
| Milestone | Dose A - Dose B - Dose A |
|---|---|
| Started | 10 |
| Completed | 5 |
| Not completed | 5 |
| Withdrew: Adverse event | 4 |
| Withdrew: Withdrawal by subject | 1 |
The CPT apparatus consists of two refrigerated circulators, filled with warm (36.5-37.5°C). participants will complete the CPT 30 minutes before the 1000h cannabis administration (baseline), and 15, 30, 45, 60, and 90 minutes post-cannabis administration. and cold (3.5 - 4.5°C) water. Participants will insert their non-dominant hand into the warm water and remove it after 3 minutes; skin temperature of the thumb pad will be measured. Participants will then insert their hand in the cold water and will be instructed to report when they first experience pain (pain threshold) and remove their hand when the cold water can no longer be tolerated (pain tolerance). Maximum immersion time will be 3 minutes. Data points reported here represent Percent Change in Pain Tolerance from Day 1 (first timepoint, 15 minutes post-cannabis \[2.98% THC / 4.91% CBD\]) across study days (Day 2, 5, 8, 9, 12, and 15). Other timepoints are not reported.
| percent change from Day 1 baseline | CPT Pain Tolerance: Day 2 | CPT Pain Tolerance: Day 5 | CPT Pain Tolerance: Day 8 | CPT Pain Tolerance: Day 9 | CPT Pain Tolerance: Day 12 | CPT Pain Tolerance: Day 15 |
|---|---|---|---|---|---|---|
| Change in Cold Pressor Test (CPT) Latency | 21.40 ± 24.22 | 10.94 ± 18.81 | 2.07 ± 5.84 | 15.17 ± 16.97 | 20.06 ± 25.07 | 30.16 ± 28.67 |
Participants rate the "high" experienced as a result of cannabis administration on a 100mm visual analog scale. Data points represent Percent Change from Day 1 (first timepoint, 15 minutes post-cannabis \[2.98% THC / 4.91% CBD\]) across study days (Day 2, 5, 8, 9, 12, and 15) Repeats at days 1, 2, 5, 8, 9, 12, and 15.
| score on a scale | Day 1 Cannabis Rating Form: "High" | Day 2 Cannabis Rating Form: "High" | Day 5 Cannabis Rating Form: "High" | Day 8 Cannabis Rating Form: "High" | Day 9 Cannabis Rating Form: "High" | Day 12 Cannabis Rating Form: "High" | Day 15 Cannabis Rating Form: "High" |
|---|---|---|---|---|---|---|---|
| Change in Cannabis Rating Form (CRF) Ratings | 14.60 ± 7.53 | 9.6 ± 7.756 | 17.60 ± 12.66 | 11.20 ± 8.16 | 30.80 ± 10.29 | 42.00 ± 18.20 | 41.40 ± 15.84 |
Collected over Information on adverse events was collected continuously for the duration of study participation for each participant, which was approximately 1 month (screening through study completion). All participants received the same order of drug administration and as such, are reported under one condition.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Participants | 0/10 (0%) | 0/10 (0%) | 4/10 (40%) |
| Event | All Participants |
|---|---|
| High blood pressureCardiac disorders | 1/10 |
| Acid refluxGastrointestinal disorders | 1/10 |
| High blood pressureCardiac disorders | 1/10 |
| High blood pressureCardiac disorders | 1/10 |
| Age, Categorical(Participants) | Dose A - Dose B - Dose A |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 5 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Dose A - Dose B - Dose A |
|---|---|
| Female | 1 |
| Male | 4 |
| Ethnicity (NIH/OMB)(Participants) | Dose A - Dose B - Dose A |
|---|---|
| Hispanic or Latino | 2 |
| Not Hispanic or Latino | 3 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Dose A - Dose B - Dose A |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 3 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(Participants) | Dose A - Dose B - Dose A |
|---|---|
| United States | 5 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Jun 2021 to primary completion in Dec 2023, 30 months.
Results were first posted in Aug 2025, 1 year 7 months after primary completion. A results delay was requested in Dec 2024.
Of 124 non-industry phase 2 interventional studies under Pain, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 60. This study's 30 months is close to that.
Counting every sponsor, half of 186 studies reached it within 21 months; a quarter within 7 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Cannabis sativa subsp. indica TOP
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