Clinical trial NCT03099005: Effect of Cannabis and Endocannabinoids on HIV Neuropathic Pain
Official title: Effect of Cannabis Administration and Endocannabinoids on HIV Neuropathic Pain Primary Study - Phase 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cannabis
HIV Neuropathy
Pain Syndrome
Keywords: neuropathic pain
human immunovirus
vaporized cannabis
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2017-04-04
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Acutely administered CBD/THC will reduce HIV-neuropathic pain in a stair-step manner; the highest CBD dose will provide the greatest pain reduction (high CBD \> medium CBD \> low CBD).
Primary purpose: TREATMENT

Brief 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

Detailed description: Our objective is to assess 120 community-dwelling people living with HIV who have neuropathic pain and are currently using cannabis. These participants will be enrolled in a study that consists of two phases:

Phase 1) This will involve a cross over study involving three different doses of vaporized cannabis that contain THC and varying concentrations of CBD:

* Low CBD session: 8 puffs of 1.9% THC + 0.01% CBD
* Medium CBD sessions: 4 puffs of 1.4% THC + 0.01% CBD plus 4 puffs of 1.4% THC + 5.1% CBD
* High CBD sessions: 8 puffs of 1.4% THC + 5.1% CBD

This phase will examine the acute effects of cannabis on pain intensity, blood endocannabinoid levels, and the relationship of pain with heart rate variability (HRV).

Phase 2) This phase will involve the association between dispensary-obtained cannabis and changes in pain reported via IMPACT, a mHealth text messaging program that will serve as a useful tool to monitor the relationship between pain and cannabis use. Text messaging is an effective method to modify health behaviors, monitor substance use, and track pain. Our group has recently demonstrated the feasibility of using short message service (SMS) texting to promote anti-retroviral therapy adherence and monitor daily methamphetamine (METH) use in persons living with HIV neuropathy with bipolar disorder or METH dependence.

Eligibility 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

Primary outcomes:
measure: Phase 1 - Numerical Pain Rating Scale (NPRS)
timeFrame: Pain is measured once before they receive study medication and then 2 minutes after drug treatment.
Secondary outcomes:
measure: Phase 1 - Patient Global Impression of Change (PGIC)
timeFrame: The PGIC was measured two minutes after drug administration.
measure: Phase 1 - Von Frey Test
timeFrame: The von Frey test was administered before drug administration and two minutes after drug administration.
measure: Phase 1 - Marijuana Subscale (M-scale) of the Addiction Research Center Inventory (ARCI)
timeFrame: The M-scale was administered 2 minutes after drug treatment.
measure: Phase 1 - Levels of the Endocannabinoid Biomarker Anandamide (AEA)
timeFrame: AEA was quantified 60 minutes after drug administration.
Other outcomes:
Locations:
city: San Diego
country: United States
facility: UC Center for Medicinal Cannabis Research, UC San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: Brook L Henry, PhD
role: PRINCIPAL_INVESTIGATOR
References: