Effect of Cannabis and Endocannabinoids on HIV Neuropathic Pain

NCT03099005 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 170510
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Conditions

Cannabis; HIV Neuropathy; Pain Syndrome

Keywords

neuropathic pain; human immunovirus; vaporized cannabis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Phase 1 - Patient Global Impression of Change (PGIC)

  The PGIC was measured two minutes after drug administration.

• Phase 1 - Von Frey Test

  The von Frey test was administered before drug administration and two minutes after drug administration.

• Phase 1 - Marijuana Subscale (M-scale) of the Addiction Research Center Inventory (ARCI)

  The M-scale was administered 2 minutes after drug treatment.

• Phase 1 - Levels of the Endocannabinoid Biomarker Anandamide (AEA)

  AEA was quantified 60 minutes after drug administration.

Study Arms (3)

Low CBD session

ACTIVE COMPARATOR

In the morning, participants will inhale 8 puffs of vaporized cannabis containing 1.9% THC + 0.01% CBD. They will then undergo experimental testing as described below under Outcome Measures.

Drug: Cannabis

Medium CBD session

ACTIVE COMPARATOR

In the morning, participants will inhale 8 puffs of vaporized cannabis 4 puffs will contain 1.9% THC + 0.01% CBD and 4 puffs will contain 1.4% THC + 5.1% CBD. They will then undergo experimental testing as described below under Outcome Measures.

Drug: Cannabis

High CBD session

ACTIVE COMPARATOR

In the morning, participants will inhale 8 puffs of vaporized cannabis containing 1.4% THC + 5.1% CBD. They will then undergo experimental testing as described below under Outcome Measures.

Drug: Cannabis

Interventions

Cannabis DRUG

vaporization of cannabis

Also known as: marijuana

High CBD session; Low CBD session; Medium CBD session

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UC Center for Medicinal Cannabis Research, UC San Diego

San Diego, California, 92103, United States

Location

MeSH Terms

Conditions

Marijuana Abuse; Somatoform Disorders; Neuralgia

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Brook Henry
• Organization: UCSD

blhenry@ucsd.edu

(619) 543-4737

Study Officials

• Brook L Henry, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will receive vaporized cannabis using Volcano vaporizers (Storz and Bickel) with either 3.74% THC + 0.49% CBD, 3.49% THC + 4.17% CBD, or 3.11% THC + 15.76% CBD at each of three visits. Allocation assignment of visits will be assigned using a Web-based random number- generating program, "Research Randomizer" (http:// www.randomizer.org/). The allocation schedule will be kept in the pharmacy and concealed from other study personnel.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Research Scientist

Model Details: 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).

Study Record Dates

• First Submitted: March 28, 2017
• First Posted: April 4, 2017
• Study Start: July 1, 2018
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: June 18, 2024
• Results First Posted: June 18, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)