Phase 2 N=5 Randomized Quadruple-blind Treatment

Effect of Cannabis and Endocannabinoids on HIV Neuropathic Pain

Cannabis · HIV Neuropathy · Pain Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT03099005 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2024

Primary outcome: Primary: Phase 1 - Numerical Pain Rating Scale (NPRS) — 2.2; 2.6; 2.8; 1.4 units on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Cannabis (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of California, San Diego
Primary completion: Dec 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Phase 1 - Numerical Pain Rating Scale (NPRS)	2.2; 2.6; 2.8; 1.4; 1.2; 1.2	—
SECONDARY Phase 1 - Patient Global Impression of Change (PGIC)	2.8; 2.6; 3.4	—
SECONDARY Phase 1 - Von Frey Test	28; 13.4; 14.5; 7.4; 10.8; 8.8	—
SECONDARY Phase 1 - Marijuana Subscale (M-scale) of the Addiction Research Center Inventory (ARCI)	1.4; 3.2; 1.8	—
SECONDARY Phase 1 - Levels of the Endocannabinoid Biomarker Anandamide (AEA)	0.52; 0.53; 0.49	—

Summary

Acute cannabis administration is reported to alleviate HIV neuropathic pain (HIV-NP), but there is limited knowledge about the effects of cannabis constituents (delta-9 tetrahydrocannabinol/THC and cannabidiol/CBD), the consequences of long-term cannabis use, and the impact of cannabis on endocannabinoid (EC) function in people living with HIV- NP. Our objective is to address these three fundamental gaps in our knowledge by: 1) examining the acute effects of various CBD/THC products on HIV-NP, 2) utilizing a mHealth text messaging protocol, Individual Monitoring of Pain and Cannabis Taken (IMPACT) to monitor daily real-world cannabis use and changes in pain; and 3) studying the relationship between cannabinoids, EC biomarkers, and chronic neuropathic pain

Eligibility Criteria

Inclusion Criteria

the ability to provide informed consent
age 18 or older
HIV infection documented at the HNRP or assessed by an HIV test at screening;
a diagnosis of HIV sensory neuropathy
current use of cannabis
the ability to describe the THC and CBD content in the products they use, i.e., obtaining cannabis from dispensaries that list THC and CBD content
ability to respond to daily text message

Exclusion Criteria

meeting criteria for current substance or alcohol dependence
traumatic brain injury
dementia or Alzheimer's disease
psychosis
a respiratory condition, i.e., pulmonary disease, that would be exacerbated by inhaling vaporized cannabis
history of cardiovascular disease, including myocardial infarction or stroke;
uncontrolled hypertension, defined as a systolic blood pressure greater than 160 mm Hg or a diastolic blood pressure greater than 100 mm Hg
pregnancy, breastfeeding, or unwillingness to prevent pregnancy during the cannabis administration portion of the study (using birth control in female participants of child- bearing age)
unwillingness or inability to receive or respond to text messages

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03099005). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.