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HIV InfectionsPITCH-ENCT04860089

Pain, Inflammation, and Cannabis in HIV

An observational study of HIV Infections and Neuropathic Pain, run by Montefiore Medical Center.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This study will examine how medical cannabis use affects neuropathic pain, inflammation and adverse events in people living with HIV (PLWH) with neuropathic pain. We will study how varying ratios of THC and CBD in medical cannabis impact neuropathic pain, inflammation and adverse events. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HIV Infections, Neuropathic Pain, Cannabis
How many people
0 participants
Where
No sites listed yet
Study dates
Aug 2022to 30 Jun 2025
Phase
Observational
Are there results?
None posted in the registry

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

Study population: Adults with HIV and neuropathic pain, who are not taking opioids and are actively certified for medical cannabis in New York

Who may be able to join

  • >= 18 years old
  • Diagnosis of HIV
  • Fluency in English
  • Active certification for medical cannabis
  • No medical cannabis dispensed or used within the previous 30 days
  • Intends to purchase soft-gel capsule medical cannabis at Vireo
Show all 9Show fewer
  • ICD-10 diagnosis code for neuropathic pain, OR
  • Neuropathic pain in problem list of electronic medical record, OR
  • Neuropathic pain questionnaire-short form>0

Who cannot join

  • Inability to provide informed consent
  • Inability to complete 14 weeks of study visits
  • Medical cannabis use within 30 days prior to enrollment
  • Unique pain symptoms (e.g. multiple sclerosis, rheumatoid arthritis)
  • Terminal illness
  • Current or prior psychotic disorder
Show all 10Show fewer
  • Street cannabis, opioid, cocaine, or benzodiazepine use in the past 30 days
  • Dispensed opioids of benzodiazepines within 60 days
  • Non-steroidal anti-inflammatory use within 7 days prior to enrollment
  • Steroid use within the past 14 days with duration of therapy >=21 days

About this study

Official title: The Impact of Medical Cannabis on Pain and Inflammation in People Living With HIV

This study will examine how medical cannabis use affects neuropathic pain, inflammation and adverse events in people living with HIV (PLWH) with neuropathic pain. We will study how varying ratios of THC and CBD in medical cannabis impact neuropathic pain, inflammation and adverse events.

Read the detailed description

This study will examine how medical cannabis use affects neuropathic pain in PLWH with neuropathic pain. We will enroll adults with HIV who have a) neuropathic pain, b) are actively certified for medical cannabis, and c) intend to have soft gel capsule products dispensed at Vireo (medical cannabis dispensary) (including a high THC:low CBD product, an equal THC:CBD product, and a low THC:high CBD product). Over 14 weeks, data sources will include questionnaires, blood samples, urine samples; medical, pharmacy, and Prescription Monitoring Program (PMP) records. The primary independent variable will be type of medical cannabis product dispensed at dispensary, and the primary outcome will be self-reported pain.

Medical subject headings
HIV Infections, Neuralgia, Marijuana Abuse

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain severity

    self-reported pain severity measured via the Brief Pain Interference (BPI) severity scale (1-10) with higher score indicating worse pain. Measured weekly with web- or phone-based questionnaire.

    Measured: 14 weeks

Secondary outcomes (5)

  1. Circulating levels of inflammatory cytokines

    Tests levels of recent inflammation (panel of inflammatory markers) at two time points before starting medical cannabis and 14 weeks after starting medical cannabis. Reported in pg/mL

    Measured: 14 weeks

  2. Antiretroviral adherence

    Measured at 0 and 14 weeks Visual Analog Scale [VAS] (0-100) with higher number indicating better adherence.

    Measured: 14 weeks

  3. HIV Viral load suppression

    HIV viral load measured at two time points (baseline and 14 weeks; copies/mL)

    Measured: 14 weeks

  4. Depression

    Measured at 0 and 14 weeks with the Patient Health Questionnaire- 9 [PHQ-9] (0-27) with higher score indicating worse depression

    Measured: 14 weeks

  5. Anxiety

    Measured at 0 and 14 weeks with the Generalized Anxiety Disorder-7 [GAD-7] (0-21) with higher score indicating worse anxiety

    Measured: 14 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Apr 2021
  2. Study startAug 2022 (estimated)
  3. Primary completion12 Dec 2023 (estimated)
  4. Study completion30 Jun 2025 (estimated)

Why it stopped: This protocol was never initiated. Due to a change in funding, a new study will be registered in its place.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04860089
Sponsor's protocol ID
2019-10394
Other IDs
GRANT13267147, 1K23DA053997-01A1, 2019
Acronym
PITCH-E
Status last verified
Sep 2022
First submitted
21 Apr 2021
Last updated
22 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of HIV Infections and Neuropathic Pain, run by Montefiore Medical Center.

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 9 inclusion and 10 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: withdrawn, as of the sponsor's last update on 22 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

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.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Pain severity (time frame: 14 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04860089.

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 22 Sep 2022.

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