Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • HIV Infections
  • Neuropathic Pain
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Triple (Participant, Care Provider, Investigator)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

This study will test how research vouchers for medical cannabis use affects neuropathic pain in PLWH with neuropathic pain. PITCH is a 2-arm randomized trial in which 100 adult PLWH with neuropathic pain and medical cannabis certification in New York State are randomized 1:1 to 1) vouchers for high ...

This study will test how research vouchers for medical cannabis use affects neuropathic pain in PLWH with neuropathic pain. PITCH is a 2-arm randomized trial in which 100 adult PLWH with neuropathic pain and medical cannabis certification in New York State are randomized 1:1 to 1) vouchers for high delta-9-tetrahydrocannabinol (THC) capsules (4.3 mg THC/0.7 mg CBD soft-gel capsules), or 2) vouchers for high cannabidiol (CBD) capsules (0.2 mg THC/4.8 mg CBD soft-gel capsules). Over 14 weeks, participants will have 5 in-person visits and 15 web- or phone-based questionnaires. Data sources will be blood samples, questionnaires, and medical and pharmacy records.

Tracking Information

NCT #
NCT04860089
Collaborators
  • National Institute on Drug Abuse (NIDA)
  • University of Colorado, Boulder
  • University of Pittsburgh
  • Vireo Health
Investigators
Principal Investigator: Deepika E Slawek, MD, MPH, MS Montefiore Medical Center