Effect of Cannabis and Endocannabinoids on HIV Neuropathic Pain

Cannabis Clinical Trial

Official title:

Effect of Cannabis Administration and Endocannabinoids on HIV Neuropathic Pain Primary Study - Phase 2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03099005
• Other study ID #: 170510
• Status: Completed
• Phase: Phase 2
• Start date: July 1, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: May 2024
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cannabis
• HIV Neuropathy
• Marijuana Abuse
• Neuralgia
• Pain Syndrome

Intervention

Drug:
• Cannabis
vaporization of cannabis

Locations

Country	Name	City	State
United States	UC Center for Medicinal Cannabis Research, UC San Diego	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase 1 - Numerical Pain Rating Scale (NPRS)	This is a scale from 0 to 10 indicating the self-reported level of pain. 0 is the minimum score, indicating no pain. 10 is the maximum score indicating highest level of pain.	Pain is measured once before they receive study medication and then 2 minutes after drug treatment.
Secondary	Phase 1 - Patient Global Impression of Change (PGIC)	This is a 7-point ordinal scale that asks the participant to rate improvement in their pain after drug administration compared to before drug administration. The scale range is 1 to 7. A score of 1 indicates the greatest improvement (reduction) in pain. A score of 7 indicates that pain is worse.	The PGIC was measured two minutes after drug administration.
Secondary	Phase 1 - Von Frey Test	This test measures sensitivity to pain causes by physical contact with the skin. The von Frey filament is applied to the dorsum of the more painful foot until bending is observed for 3 seconds. Pain is rated using a visual analog score (VAS). The scale is 0 to 100, where 0 indicates no pain and 100 indicates the worst pain.	The von Frey test was administered before drug administration and two minutes after drug administration.
Secondary	Phase 1 - Marijuana Subscale (M-scale) of the Addiction Research Center Inventory (ARCI)	The M-scale has 12 true/false statements describing the subjective effects of marijuana on participants after they take the drug. Each question is scored as 0 or 1. The scale ranges from 0 (minimum score) to 12 (maximum score). A lower score indicates that the participant is experiencing fewer side effects of the drug. A higher score indicates that the participant is experiencing more side effects of the drug. Reported side effects on this scale include dry mouth, slower movements, shaking hands, and having a pleasant feeling.	The M-scale was administered 2 minutes after drug treatment.
Secondary	Phase 1 - Levels of the Endocannabinoid Biomarker Anandamide (AEA)	Anandamide levels in plasma were quantified using liquid chromatography-tandem mass spectrometry (LC/MS).	AEA was quantified 60 minutes after drug administration.