Pain, Inflammation, and Cannabis in HIV

NCT04860089 | Withdrawn

• 3 other identifiers: 2019-10394GRANT132671471K23DA053997-01A1
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

HIV Infections; Neuropathic Pain; Cannabis

Outcome Measures

Primary Outcomes (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.

  14 weeks

Secondary Outcomes (5)

• Circulating levels of inflammatory cytokines

  14 weeks

• Antiretroviral adherence

  14 weeks

• HIV Viral load suppression

  14 weeks

• Depression

  14 weeks

• Anxiety

  14 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• \>= 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Montefiore Medical Center: lead
• National Institute on Drug Abuse (NIDA): collaborator
• University of Colorado, Boulder: collaborator
• University of Pittsburgh: collaborator
• Vireo Health: collaborator

MeSH Terms

Conditions

HIV Infections; Neuralgia; Marijuana Abuse

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Deepika E Slawek, MD, MPH, MS

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: April 21, 2021
• First Posted: April 26, 2021
• Study Start: August 1, 2022
• Primary Completion: December 12, 2023
• Study Completion: June 30, 2025
• Last Updated: September 22, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share