Pain, Inflammation, and Cannabis in HIV | NCT04860089

Studies
Pain, Inflammation, and Cannabis in HIV

NCT04860089

Sponsor

Montefiore Medical Center

Status

Withdrawn

Last Update Posted

Sep 22, 2022Actual

Enrollment

0Actual

Phase

Not provided

Conditions

HIV Infections
Neuropathic Pain
Cannabis

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
GRANT13267147	Other Grant/Funding Number	NIDA
1K23DA053997-01A1	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Sep 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

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

Expanded Access Info

Start Date

Aug 2022Estimated

Primary Completion Date

Dec 12, 2023Estimated

Completion Date

Jun 30, 2025Estimated

First Submitted Date

Apr 21, 2021

First Submission Date that Met QC Criteria

Apr 22, 2021

First Posted Date

Apr 26, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 20, 2022

Last Update Posted Date

Sep 22, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Deepika Slawek, Assistant Professor of Medicine, Montefiore Medical CenterPrincipal Investigator

Lead Sponsor

Montefiore Medical CenterOTHER

Collaborators

Name	Class
National Institute on Drug Abuse (NIDA)	NIH
University of Colorado, Boulder	OTHER
University of Pittsburgh	OTHER
Vireo Health

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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. We will study how varying ratios of THC and CBD 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. 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	14 weeks

Secondary Outcomes

Measure	Description	Time Frame
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	14 weeks
Antiretroviral adherence

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Deepika E Slawek, MD, MPH, MS	Montefiore Medical Center	Principal Investigator

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015658	HIV Infections
D009437	Neuralgia
D002189	Marijuana Abuse

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral

Browse Leaves

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Browse Branches

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