Effect of Cannabis and Endocannabinoids on HIV Neuropathic Pain

• Status: Recruiting
• Trial end date: 2021-12-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, San Diego

Criteria

Inclusion Criteria:

1. the ability to provide informed consent

2. age 18 or older

3. HIV infection documented at the HNRP or assessed by an HIV test at screening;

4. a diagnosis of HIV sensory neuropathy

5. current use of cannabis

6. 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

7. ability to respond to daily text message

Exclusion Criteria:

1. meeting criteria for current substance or alcohol dependence

2. traumatic brain injury

3. dementia or Alzheimer's disease

4. psychosis

5. a respiratory condition, i.e., pulmonary disease, that would be exacerbated by inhaling vaporized cannabis

6. history of cardiovascular disease, including myocardial infarction or stroke;

7. uncontrolled hypertension, defined as a systolic blood pressure greater than 160 mm Hg or a diastolic blood pressure greater than 100 mm Hg

8. 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)

9. unwillingness or inability to receive or respond to text messages