Repeated Cannabis Administration on Experimental Pain and Abuse Liability
Status:
Recruiting
Trial end date:
2025-12-31
Target enrollment:
Participant gender:
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 [1].
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.
Phase:
Phase 2
Details
Lead Sponsor:
New York State Psychiatric Institute
Collaborators:
Alkermes, Inc. National Institute on Drug Abuse (NIDA)