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Pain Inflammation and Cannabis in HIV (PITCH-E)

Primary Purpose

HIV Infections, Neuropathic Pain, Cannabis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Receipt of Coupon for Placebo Soft-Gel Capsule
Receipt of Coupon for High THC Soft-Gel Capsule
Receipt of Coupon for Equal THC and CBD Soft-Gel Capsule
Receipt of Coupon for High CBD Soft-Gel Capsule
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV Infections

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • >= 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
  • ICD-10 (International Classification of Diseases 10th Revision) diagnosis code for neuropathic pain, OR
  • Neuropathic pain in problem list of electronic medical record, OR
  • Neuropathic pain questionnaire-short form>0

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • Montefiore Health SystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Other

Other

Other

Other

Arm Label

Coupon for a Discounted Placebo Product

Coupon for a Discounted High THC Product

Coupon for a Discounted Equal THC and CBD Product

Coupon for a Discounted High CBD Product

Arm Description

We will observe participants who were previously randomized to a coupon for discounted placebo soft-gel capsules by our collaborators, Vireo.

We will observe participants who were previously randomized to a coupon for discounted 4.3 mg THC/0.7 mg CBD soft-gel capsules by our collaborators, Vireo.

We will observe participants who were previously randomized to a coupon for discounted 2.5 mg THC/2.5 mg CBD soft-gel capsules by our collaborators, Vireo.

We will observe participants who were previously randomized to a coupon for discounted 0.2 mg THC/4.8 mg CBD soft-gel capsules by our collaborators, Vireo.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Antiretroviral adherence
Measured at 0 and 14 weeks Visual Analog Scale [VAS] (0-100) with higher number indicating better adherence.
HIV Viral load suppression
HIV viral load measured at two time points (baseline and 14 weeks; copies/mL)
Depression
Measured at 0 and 14 weeks with the Patient Health Questionnaire- 9 [PHQ-9] (0-27) with higher score indicating worse depression
Anxiety
Measured at 0 and 14 weeks with the Generalized Anxiety Disorder-7 [GAD-7] (0-21) with higher score indicating worse anxiety

Full Information

First Posted
September 21, 2022
Last Updated
May 31, 2023
Sponsor
Montefiore Medical Center
Collaborators
National Institute on Drug Abuse (NIDA), University of Colorado, Boulder, University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT05554146
Brief Title
Pain Inflammation and Cannabis in HIV
Acronym
PITCH-E
Official Title
The Impact of Medical Cannabis on Pain and Inflammation in People Living With HIV
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 28, 2022 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefiore Medical Center
Collaborators
National Institute on Drug Abuse (NIDA), University of Colorado, Boulder, University of Pittsburgh

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. The investigators will observe how varying ratios of THC (tetrahydrocannabinol) and CBD (cannabidiol) in medical cannabis impact neuropathic pain, inflammation and adverse events.
Detailed Description
This study will examine how medical cannabis use affects neuropathic pain in PLWH with neuropathic pain. The investigators 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). The investigators will observe how pain and inflammation change in participants after they are randomized to receive high THC:low CBD product, an equal THC:CBD product, a low THC:high CBD product, or placebo by our collaborator in a separate study. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections, Neuropathic Pain, Cannabis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
We will observe participants who are enrolled in one of 4 arms in a partnering study over 14 weeks.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Coupon for a Discounted Placebo Product
Arm Type
Other
Arm Description
We will observe participants who were previously randomized to a coupon for discounted placebo soft-gel capsules by our collaborators, Vireo.
Arm Title
Coupon for a Discounted High THC Product
Arm Type
Other
Arm Description
We will observe participants who were previously randomized to a coupon for discounted 4.3 mg THC/0.7 mg CBD soft-gel capsules by our collaborators, Vireo.
Arm Title
Coupon for a Discounted Equal THC and CBD Product
Arm Type
Other
Arm Description
We will observe participants who were previously randomized to a coupon for discounted 2.5 mg THC/2.5 mg CBD soft-gel capsules by our collaborators, Vireo.
Arm Title
Coupon for a Discounted High CBD Product
Arm Type
Other
Arm Description
We will observe participants who were previously randomized to a coupon for discounted 0.2 mg THC/4.8 mg CBD soft-gel capsules by our collaborators, Vireo.
Intervention Type
Other
Intervention Name(s)
Receipt of Coupon for Placebo Soft-Gel Capsule
Intervention Description
The investigators will follow participants who were randomized to receive a coupon for placebo soft-gel capsule medical cannabis products by our collaborators at Vireo medical cannabis dispensary in a separate study
Intervention Type
Other
Intervention Name(s)
Receipt of Coupon for High THC Soft-Gel Capsule
Intervention Description
The investigators will follow participants who were randomized to receive a coupon for high THC soft-gel capsule medical cannabis products by our collaborators at Vireo medical cannabis dispensary in a separate study
Intervention Type
Other
Intervention Name(s)
Receipt of Coupon for Equal THC and CBD Soft-Gel Capsule
Intervention Description
The investigators will follow participants who were randomized to receive a coupon for equal THC and CBD soft-gel capsule medical cannabis products by our collaborators at Vireo medical cannabis dispensary in a separate study
Intervention Type
Other
Intervention Name(s)
Receipt of Coupon for High CBD Soft-Gel Capsule
Intervention Description
The investigators will follow participants who were randomized to receive a coupon for high CBD soft-gel capsule medical cannabis products by our collaborators at Vireo medical cannabis dispensary in a separate study
Primary Outcome Measure Information:
Title
Pain severity
Description
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.
Time Frame
14 weeks
Secondary Outcome Measure Information:
Title
Circulating levels of inflammatory cytokines
Description
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
Time Frame
14 weeks
Title
Antiretroviral adherence
Description
Measured at 0 and 14 weeks Visual Analog Scale [VAS] (0-100) with higher number indicating better adherence.
Time Frame
14 weeks
Title
HIV Viral load suppression
Description
HIV viral load measured at two time points (baseline and 14 weeks; copies/mL)
Time Frame
14 weeks
Title
Depression
Description
Measured at 0 and 14 weeks with the Patient Health Questionnaire- 9 [PHQ-9] (0-27) with higher score indicating worse depression
Time Frame
14 weeks
Title
Anxiety
Description
Measured at 0 and 14 weeks with the Generalized Anxiety Disorder-7 [GAD-7] (0-21) with higher score indicating worse anxiety
Time Frame
14 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: ->=18 years old Diagnosis of HIV Fluency in English Active certification for medical cannabis ICD-10 diagnosis code for neuropathic pain, OR Neuropathic pain in problem list of electronic medical record, OR Neuropathic pain per medical cannabis certification form, OR Neuropathic Pain Questionnaire-Short Form>0 Exclusion Criteria: Inability to provide informed consent Inability to complete 14 weeks of study visits Medical cannabis use within 14 days of enrollment, and no medical cannabis dispensed within 30 days of enrollment Unique pain symptoms (e.g., multiple sclerosis, rheumatoid arthritis) Terminal illness Current or prior psychotic disorder Unregulated cannabis use in the past 14 days; opioid or cocaine use in the past 30 days Dispensed opioids within 30 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 COVID vaccination or booster within 14 days of screening Active or acute cardiac disease based on clinician chart review.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Deepika E Slawek, MD, MPH, MS
Phone
718-920-3786
Email
dslawek@montefiore.org
First Name & Middle Initial & Last Name or Official Title & Degree
Giovanna DiFrancesca
Phone
718-920-5763
Email
giovanna.calderon@einsteinmed.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deepika E Slawek, MD, MPH, MS
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Health System
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Deepika Slawek, MD
Phone
718-920-3786
Email
dslawek@montefiore.org
First Name & Middle Initial & Last Name & Degree
Giovanna DiFrancesca
Phone
718-920-5763
Email
giovanna.calderon@einsteinmed.org

12. IPD Sharing Statement

Plan to Share IPD
No

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Pain Inflammation and Cannabis in HIV

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