Effect of Cannabis and Endocannabinoids on HIV Neuropathic Pain

University of California San Diego logo

University of California San Diego

Status and phase

Completed
Phase 2

Conditions

HIV Neuropathy
Pain Syndrome
Cannabis

Treatments

Drug: Cannabis

Study type

Interventional

Funder types

Other

Identifiers

NCT03099005
170510

Details and patient eligibility

About

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

Full 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 1.6% THC + 0.09 CBD Medium CBD sessions: 4 puffs of 1.6% THC + 0.09 CBD plus 4 puffs of 1.73% THC + 5.4% CBD High CBD sessions: 8 puffs of 1.73% THC + 5.4% 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.

Enrollment

44 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

44 participants in 3 patient groups

Low CBD session
Active Comparator group
Description:
In the morning, participants will inhale 8 puffs of vaporized cannabis containing 1.6% THC + 0.09 CBD. They will then undergo experimental testing as described below under Outcome Measures.
Treatment:
Drug: Cannabis
Medium CBD session
Active Comparator group
Description:
In the morning, participants will inhale 8 puffs of vaporized cannabis 4 puffs will contain 1.6% THC + 0.09 CBD and 4 puffs will contain 1.73% THC + 5.4% CBD. They will then undergo experimental testing as described below under Outcome Measures.
Treatment:
Drug: Cannabis
High CBD session
Active Comparator group
Description:
In the morning, participants will inhale 8 puffs of vaporized cannabis containing 1.73% THC + 5.4% CBD. They will then undergo experimental testing as described below under Outcome Measures.
Treatment:
Drug: Cannabis

Trial contacts and locations

1

Loading...

Central trial contact

Brook L Henry, PhD; Recruitment Office

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems