CannabisPhase 2NCT03099005
Effect of Cannabis and Endocannabinoids on HIV Neuropathic Pain
A Phase 2 study testing Cannabis in people with Cannabis and HIV Neuropathy, run by University of California, San Diego at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cannabis, HIV Neuropathy, Pain Syndrome
- What is being tested?
- Cannabis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2018to 31 Dec 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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 locations and contacts
1 site in 1 country.
United States1 site
UC Center for Medicinal Cannabis Research, UC San Diego
San Diego, California, 92103
About this study
Official title: Effect of Cannabis Administration and Endocannabinoids on HIV Neuropathic Pain Primary Study - Phase 2
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
Read the 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.
- Conditions
- Cannabis, HIV Neuropathy, Pain Syndrome
- Being tested
- Cannabis
- Keywords
- neuropathic pain, human immunovirus, vaporized cannabis
- Medical subject headings
- Marijuana Abuse, Somatoform Disorders, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabisDrug
Also called marijuana
vaporization of cannabis
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Cannabis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: The PGIC was measured two minutes after drug administration.
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.
Measured: 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 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.
Measured: The M-scale was administered 2 minutes after drug treatment.
Phase 1 - Levels of the Endocannabinoid Biomarker Anandamide (AEA)
Anandamide levels in plasma were quantified using liquid chromatography-tandem mass spectrometry (LC/MS).
Measured: AEA was quantified 60 minutes after drug administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study start1 Jul 2018
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CannabisStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brook Henry, University of California, San Diego
- Investigators
- Brook L Henry, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03099005
- Sponsor's protocol ID
- 170510
- Status last verified
- May 2024
- First submitted
- 28 Mar 2017
- Last updated
- 18 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The principal investigator, Brook Henry PhD (blhenry@ucsd.edu), will supply individual participant data to other researchers after the project is completed.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cannabis Administration and Endocannabinoids on HIV Neuropathic Pain Primary Study - Phase 2
- ClinicalTrials.gov ID
- NCT03099005
- Acronym / sponsor ID
- 170510
- Conditions
- Cannabis, HIV Neuropathy, Pain Syndrome
- Keywords
- neuropathic pain, human immunovirus, vaporized cannabis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 4 Apr 2017 (actual)
- Results
- Posted 18 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- 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).
| Arm | Type | Receives |
|---|---|---|
| Low CBD session | Active comparator | Drug: CannabisIn 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. |
| Medium CBD session | Active comparator | Drug: CannabisIn 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. |
| High CBD session | Active comparator | Drug: CannabisIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CannabisAlso: marijuanavaporization of cannabis | Drug | High CBD session, Low CBD session, Medium CBD session |
Primary outcome
Phase 1 - Numerical Pain Rating Scale (NPRS)
Time frame: Pain is measured once before they receive study medication and then 2 minutes after drug treatment.
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.
4 secondary outcomes
Phase 1 - Patient Global Impression of Change (PGIC)
Time frame: The PGIC was measured two minutes after drug administration.
Phase 1 - Von Frey Test
Time frame: 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)
Time frame: The M-scale was administered 2 minutes after drug treatment.
Phase 1 - Levels of the Endocannabinoid Biomarker Anandamide (AEA)
Time frame: AEA was quantified 60 minutes after drug administration.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. The principal investigator, Brook Henry PhD (blhenry@ucsd.edu), will supply individual participant data to other researchers after the project is completed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brook L Henry, PhD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cannabis in people with Cannabis and HIV Neuropathy, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1 - Numerical Pain Rating Scale (NPRS) (time frame: Pain is measured once before they receive study medication and then 2 minutes after drug treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2024.