Effect of Cannabis and Endocannabinoids on HIV Neuropathic Pain
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ClinicalTrials.gov Identifier: NCT03099005 |
Recruitment Status :
Recruiting
First Posted : April 4, 2017
Last Update Posted : January 11, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cannabis HIV Neuropathy Pain Syndrome | Drug: Cannabis | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 120 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
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). |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Masking Description: | 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. |
Primary Purpose: | Treatment |
Official Title: | Effect of Cannabis Administration and Endocannabinoids on HIV Neuropathic Pain Primary Study - Phase 2 |
Actual Study Start Date : | July 1, 2018 |
Estimated Primary Completion Date : | September 30, 2022 |
Estimated Study Completion Date : | December 31, 2022 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Low CBD session
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.
|
Drug: Cannabis
vaporization of cannabis
Other Name: marijuana |
Active Comparator: Medium CBD session
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.
|
Drug: Cannabis
vaporization of cannabis
Other Name: marijuana |
Active Comparator: High CBD session
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.
|
Drug: Cannabis
vaporization of cannabis
Other Name: marijuana |
- Phase 1 - numerical 11-point Pain Intensity Scale [ Time Frame: participants will be followed for the duration of an 4 hour, single day human laboratory experiment, and the outcome will be measured once before they receive study medication and then 3 additional times during the treatment day ]an ordinal scale
- Phase 2 - numerical 11-point Pain Intensity Scale [ Time Frame: participants will be queried on a daily basis for six months using text messaging ]participants receive interactive text questions sent once a day to their cell phone asking them to indicate their average pain level for the day on a 0 to 10 scale
- Phase 1 - Patient Global Impression of Change (PGIC) [ Time Frame: participants will be followed for the duration of an 4 hour, single day human laboratory experiment, and this outcome will be measured 3 times after study medication is provided during the treatment day ]a 7 point ordinal scale reflective of improvement in pain
- Phase 1 - von Frey test [ Time Frame: participants will be followed for the duration of an 4 hour, single day human laboratory experiment, and the outcome will be measured once before they receive study medication and then 3 additional times during the treatment day ]The von Frey filament will be applied on the dorsum of the more painful foot until bending is observed for 3 seconds, followed by a VAS pain rating
- Phase 1 - Marijuana subscale (M-scale) of the Addiction Research Center Inventory (ARCI) [ Time Frame: participants will be followed for the duration of an 4 hour, single day human laboratory experiment, and the outcome will be measured once before they receive study medication and then 3 additional times during the treatment day ]The M -scale has 12 true/false statements describing the subjective effects of marijuana
- Phase 1 - Neuropsychological Assessment Battery [ Time Frame: participants will be followed for the duration of an 4 hour, single day human laboratory experiment, and the outcome will be measured once before they receive study medication and then 3 additional times during the treatment day ]Testing will include the Wechsler Adult Intelligence Scale (WAIS-III) Digit Symbol, Hopkins Verbal Learning Test-Revised and Grooved Pegboard Test (motor)
- Phase 1 - heart rate variability [ Time Frame: participants will be followed for the duration of an 4 hour, single day human laboratory experiment, and the outcome will be measured once before they receive study medication and then 3 additional times during the treatment day ]Heart Rate Variability (HRV) correlates with the level of pain intensity. Persons with effective analgesic treatment of chronic pain exhibited improved HRV relative to pain sufferers with ineffective treatment suggesting HRV may serve as a pain biomarker
- Phase 1 - store plasma samples for evaluation of THC, CBD, and endocannabinoid system biomarkers [ Time Frame: participants will be followed for the duration of an 4 hour, single day human laboratory experiment, and the outcome will be measured once before they receive study medication and then 3 additional times during the treatment day ]Cannabinoid and endocannabinoid levels in plasma will be quantified using a liquid chromatography-tandem mass spectrometry (LC/MS)

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03099005
Contact: Brook L Henry, PhD | (619) 543-4737 | blhenry@ucsd.edu | |
Contact: Recruitment Office | hnrprecruitment@ucsd.edu |
United States, California | |
UC Center for Medicinal Cannabis Research, UC San Diego | Recruiting |
San Diego, California, United States, 92103 | |
Contact: Brook L Henry, PhD 619-543-4737 blhenry@ucsd.edu | |
Principal Investigator: Brook L Henry, PhD | |
Sub-Investigator: Ron O Ellis, MD, PhD | |
Sub-Investigator: David Grelotti, MD |
Principal Investigator: | Brook L Henry, PhD | University of California, San Diego |
Responsible Party: | Brook Henry, Assistant Research Scientist, University of California, San Diego |
ClinicalTrials.gov Identifier: | NCT03099005 |
Other Study ID Numbers: |
170510 |
First Posted: | April 4, 2017 Key Record Dates |
Last Update Posted: | January 11, 2022 |
Last Verified: | January 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | The principal investigator, Brook Henry PhD (blhenry@ucsd.edu), will supply individual participant data to other researchers after the project is completed. |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
neuropathic pain human immunovirus vaporized cannabis |
Neuralgia Marijuana Abuse Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases |
Pain Neurologic Manifestations Substance-Related Disorders Chemically-Induced Disorders Mental Disorders |