CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 10 enrolled
Drug / intervention
Active Cannabis +1 moredrug
Likely dose
Not stated in record
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Search/NCT04576507
NCT04576507Phase 2Completed

Effects of Repeated Cannabis Administration on Experimental Pain and Abuse Liability in Humans

New York State Psychiatric Institute·interventional·Posted Oct 6, 2020·Updated Aug 8, 2025

In Brief

A Phase 2 clinical trial evaluating Active Cannabis and Placebo Cannabis for Cannabis and 3 related conditions. Completed, enrolled 10 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsAlkermes, Inc.

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedOct 6, 2020
Enrollment StartJun 1, 2021
Primary CompletionDec 31, 2023
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 5.7 years ago

Interventions

Active Cannabisdrug

2.98% THC:4.91% CBD cannabis.

Placebo Cannabisdrug

\<0.01% THC:CBD cannabis.