NCT05554146 (PITCH-E) is a NA clinical trial of Receipt of Coupon for High THC Soft-Gel Capsule in HIV Infections, sponsored by Montefiore Medical Center.

Who is sponsoring NCT05554146?

NCT05554146 is sponsored by Montefiore Medical Center.

What drugs are being tested in NCT05554146?

Interventions in NCT05554146: 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.

What condition does NCT05554146 study?

NCT05554146 studies HIV Infections, Neuropathic Pain, Cannabis.

Is NCT05554146 still recruiting?

NCT05554146 is currently completed. Last updated 13 November 2025.

Are results published for NCT05554146?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-11-13 · How we verify

NCT05554146: PITCH-E

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Pain Inflammation and Cannabis in HIV

Completed NA Results posted Last updated 13 November 2025

What this trial tests

NA trial testing Receipt of Coupon for Placebo Soft-Gel Capsule in HIV Infections in 35 participants. Completed in 3 May 2024.

Timeline

28 October 2022

Primary endpoint
3 May 2024

3 May 2024

Quick facts

Lead sponsor	Montefiore Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	35
Start date	28 October 2022
Primary completion	3 May 2024
Estimated completion	3 May 2024
Sites	1 location across United States

Drugs / interventions tested

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

Conditions studied

HIV Infections — all drugs for HIV Infections →
Neuropathic Pain — all drugs for Neuropathic Pain →
Cannabis — all drugs for Cannabis →

Sponsor

Montefiore Medical Center

Who can join

Adults 18 to 100, any sex, with HIV Infections or Neuropathic Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Pain Severity Score Primary · At weekly intervals from Baseline to 14 weeks

Change in self-reported Pain Severity was measured at weekly intervals from baseline through 14 weeks using the Brief Pain Inventory (BPI) pain severity subscale. The BPI Pain Severity subscale uses a 0-10 numerical rating scale where 0 = "No pain at all" and 10 = "Pain as bad as you can imagine; completely interferes" such that higher scores were associated with increased Pain Severity. Participants were asked to assign a score to their pain, on average, over the prior week. Scores were summarized by study arm. For purposes of this study change in Pain Severity scores from baseline to 14 week

Week 1

Group	Value	95% CI
Coupon for a Discounted Placebo Product	6.44	± 2.07
Coupon for a Discounted High THC Product	6.86	± 2.27
Coupon for a Discounted Equal THC and CBD Product	8	± 2.38
Coupon for a Discounted High CBD Product	7.37	± 2.5

Week 2

Group	Value	95% CI
Coupon for a Discounted Placebo Product	5.87	± 3.09
Coupon for a Discounted High THC Product	6.67	± 2.58
Coupon for a Discounted Equal THC and CBD Product	7.37	± 1.76
Coupon for a Discounted High CBD Product	6.75	± 2.43

Week 3

Group	Value	95% CI
Coupon for a Discounted Placebo Product	5.22	± 3.15
Coupon for a Discounted High THC Product	5.86	± 2.23
Coupon for a Discounted Equal THC and CBD Product	7.57	± 2.25
Coupon for a Discounted High CBD Product	6.37	± 2.92

Week 4

Group	Value	95% CI
Coupon for a Discounted Placebo Product	3.87	± 2.64
Coupon for a Discounted High THC Product	6.28	± 2.63
Coupon for a Discounted Equal THC and CBD Product	7.14	± 2.73
Coupon for a Discounted High CBD Product	6.375	± 2.92

Week 5

Group	Value	95% CI
Coupon for a Discounted Placebo Product	4	± 2.87
Coupon for a Discounted High THC Product	3	± 2.34
Coupon for a Discounted Equal THC and CBD Product	7	± 2.23
Coupon for a Discounted High CBD Product	6.17	± 2.71

Week 6

Group	Value	95% CI
Coupon for a Discounted Placebo Product	4.37	± 2.72
Coupon for a Discounted High THC Product	5.14	± 3.43
Coupon for a Discounted Equal THC and CBD Product	6.25	± 2.37
Coupon for a Discounted High CBD Product	5.37	± 2.77

Week 7

Group	Value	95% CI
Coupon for a Discounted Placebo Product	4.11	± 3.62
Coupon for a Discounted High THC Product	5.57	± 2.29
Coupon for a Discounted Equal THC and CBD Product	6	± 2.2
Coupon for a Discounted High CBD Product	5.5	± 3.07

Week 8

Group	Value	95% CI
Coupon for a Discounted Placebo Product	4.25	± 3.11
Coupon for a Discounted High THC Product	4.86	± 3.67
Coupon for a Discounted Equal THC and CBD Product	6	± 2.56
Coupon for a Discounted High CBD Product	6.57	± 2.69

Change in Circulating Levels of Anti-inflammatory Cytokines - Interleukin-10 (IL-10) Secondary · From Baseline to 14 weeks

Change in circulating test levels of recent inflammation (based on a panel of inflammatory markers) from baseline to 14 weeks was analyzed. Blood draws for circulating levels of pro- and anti-inflammatory cytokines were collected, processed, and analyzed using an O-link assay which uses normal protein expression (NPX) values expressed on a log2 scale, where a higher value indicates a higher protein level. Results for IL-10 are summarized by study arm using basic descriptive statistics. For purposes of this study change in circulating levels of IL-10 from baseline to 14 weeks following interven

Group	Value	95% CI
Coupon for a Discounted Placebo Product	0.15	± 1.12
Coupon for a Discounted High THC Product	0.41	± 0.83
Coupon for a Discounted Equal THC and CBD Product	0.11	± 0.44
Coupon for a Discounted High CBD Product	0.65	± 0.85

Change in Circulating Levels of Anti-inflammatory Cytokines - Interleukin-4 (IL-4) Secondary · From Baseline to 14 weeks

Change in circulating test levels of recent inflammation (based on a panel of inflammatory markers) from baseline to 14 weeks was analyzed. Blood draws for circulating levels of pro- and anti-inflammatory cytokines were collected, processed, and analyzed using an O-link assay which uses normal protein expression (NPX) values expressed on a log2 scale, where a higher value indicates a higher protein level. Results for IL-4 are summarized by study arm using basic descriptive statistics. For purposes of this study change in circulating levels of IL-4 from baseline to 14 weeks following interventi

Group	Value	95% CI
Coupon for a Discounted Placebo Product	-0.33	± 0.57
Coupon for a Discounted High THC Product	-0.21	± 0.48
Coupon for a Discounted Equal THC and CBD Product	0.02	± 0.5
Coupon for a Discounted High CBD Product	0.07	± 0.54

Change in Circulating Levels of Pro-inflammatory Cytokines - Tumor Necrosis Factor Alpha (TNFa) Secondary · From Baseline to 14 weeks

Change in circulating test levels of recent inflammation (based on a panel of inflammatory markers) from baseline to 14 weeks was analyzed. Blood draws for circulating levels of pro- and anti-inflammatory cytokines were collected, processed, and analyzed using an O-link assay which uses normal protein expression (NPX) values expressed on a log2 scale, where a higher value indicates a higher protein level. Results for TNFa are summarized by study arm using basic descriptive statistics. For purposes of this study change in circulating levels of TNFa from baseline to 14 weeks following interventi

Group	Value	95% CI
Coupon for a Discounted Placebo Product	-0.02	± 0.64
Coupon for a Discounted High THC Product	0.03	± 0.37
Coupon for a Discounted Equal THC and CBD Product	0.05	± 0.18
Coupon for a Discounted High CBD Product	-0.18	± 0.24

Change in Circulating Levels of Pro-inflammatory Cytokines - Interleukin-6 (IL-6) Secondary · From Baseline to 14 weeks

Change in circulating test levels of recent inflammation (based on a panel of inflammatory markers) from baseline to 14 weeks was analyzed. Blood draws for circulating levels of pro- and anti-inflammatory cytokines were collected, processed, and analyzed using an O-link assay which uses normal protein expression (NPX) values expressed on a log2 scale, where a higher value indicates a higher protein level. Results for IL-6 are summarized by study arm using basic descriptive statistics. For purposes of this study change in circulating levels of IL-6 from baseline to 14 weeks following interventi

Group	Value	95% CI
Coupon for a Discounted Placebo Product	0.24	± 0.73
Coupon for a Discounted High THC Product	0.11	± 1.58
Coupon for a Discounted Equal THC and CBD Product	-0.18	± 0.83
Coupon for a Discounted High CBD Product	-0.09	± 0.33

Change in Antiretroviral Medication Adherence Score Secondary · From Baseline to 14 weeks

Change in Antiretroviral medication adherence from baseline to 14 weeks was assessed using the Visual Analog Scale (VAS) of antiretroviral therapy (ART) adherence. This is an ordinal scale representing the percentage of medication taken to that which had been administered. Participants were presented with a visual ranging from 0% to 100% scaled at 10% increments and asked to provide a best guess as to how much medicine was taken over the prior 30 days with 0% signifying no medication, 50% signifying half of administered medication taken, and 100% signifying that every single dose of medication

Group	Value	95% CI
Coupon for a Discounted Placebo Product	-1	± 2.708
Coupon for a Discounted High THC Product	0	± 0
Coupon for a Discounted Equal THC and CBD Product	2	± 3.46
Coupon for a Discounted High CBD Product	1	± 2

Change in HIV Viral Load Suppression Secondary · From Baseline to 14 weeks

Change in HIV viral load suppression from baseline was measured and assessed at 14 weeks. Blood draws were obtained at baseline and 14 weeks following intervention and samples were processed, analyzed, and quantified using the Abbott RealTime HIV-1 Viral Load assay. Results were summarized and HIV viral load values were reported in copies/milliliter (copies/mL). For purposes of this study change in HIV viral load from baseline to 14 weeks following intervention were summarized and reported. Positive values are indicative of increased HIV viral load levels compared to baseline and negative valu

Group	Value	95% CI
Coupon for a Discounted Placebo Product	-12270.43	± 32267.19
Coupon for a Discounted High THC Product	7.7	± 20.4
Coupon for a Discounted Equal THC and CBD Product	-5	± 14.9
Coupon for a Discounted High CBD Product	3737	± 9891.17

Change in Depression Score Secondary · From Baseline to 14 weeks

Change in Depression score was measured at baseline and 14 weeks using the Center for Epidemiologic Studies Depression (CES-D) questionnaire. The CES-D questionnaire is a 20-item screening tool used to assess the severity and frequency of depressive symptoms. Participants were asked to rate each of the 20 items using a 4-point Likert scale ranging from 0 ("Rarely/none of the time") to 3 ("Most/all of the time") to describe symptoms over the prior week (Questions, 4, 8, 12, and 16 were reverse-scored). Scores were summed to yield an overall possible scoring range of 0-60 with higher scores bein

Group	Value	95% CI
Coupon for a Discounted Placebo Product	-9.71	± 6.6
Coupon for a Discounted High THC Product	-9	± 9.39
Coupon for a Discounted Equal THC and CBD Product	-3.56	± 7.07
Coupon for a Discounted High CBD Product	-2.25	± 5.52

Change in Anxiety Score Secondary · From Baseline to 14 weeks

Change in Anxiety score was measured and assessed at baseline and 14 weeks using the Generalized Anxiety Disorder-7 (GAD-7). The GAD-7 is a 7-item screening tool used to assess the severity of anxiety-related symptoms. Participants were asked to rate each of the 7 items using a 4-point Likert scale ranging from 0 ("Not at all") to 3 ("Nearly every day") to indicate how long they have been bothered by the problems listed over the prior 2-week period, yielding an overall possible score of 0-21, with higher scores being indicative of worsening anxiety. Scores were summarized by study arm. For pur

Group	Value	95% CI
Coupon for a Discounted Placebo Product	-5.71	± 4.07
Coupon for a Discounted High THC Product	-1.43	± 2.57
Coupon for a Discounted Equal THC and CBD Product	-1.75	± 4.68
Coupon for a Discounted High CBD Product	-1.12	± 6.03

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to approximately 14 weeks following intervention. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Coupon for a Discounted Placebo Product

Serious: 1/9 (11%)

Deaths: 0/9

Coupon for a Discounted High THC Product

Serious: 2/8 (25%)

Deaths: 0/8

Coupon for a Discounted Equal THC and CBD Product

Serious: 0/9 (0%)

Deaths: 0/9

Coupon for a Discounted High CBD Product

Serious: 0/8 (0%)

Deaths: 0/8

Serious adverse events (4 terms)

Reaction	System	Coupon for a Discounted Pl…	Coupon for a Discounted Hi…	Coupon for a Discounted Eq…	Coupon for a Discounted Hi…
Bradycardia	Cardiac disorders	—	—	—	—
Acute Respiratory Failure	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Pneumonia	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Influenza	Infections and infestations	—	—	—	—

Other adverse events (2 terms — click to expand)

Reaction	System	Coupon for a Discounted Pl…	Coupon for a Discounted Hi…	Coupon for a Discounted Eq…	Coupon for a Discounted Hi…
Peripheral Neuropathy	Nervous system disorders	—	—	—	—
Knee Pain	Musculoskeletal and connective tissue disorders	—	—	—	—

Most-reported serious reactions: Bradycardia, Acute Respiratory Failure, Pneumonia, Influenza.

Data from ClinicalTrials.gov NCT05554146 adverse events section.

Sponsor's own description

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 tetrahydrocannabinol (THC) and cannabidiol (CBD) in medical cannabis impact neuropathic pain, inflammation and adverse events.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Transcriptomic Alterations Induced by Tetrahydrocannabinol in SIV/HIV Infection: A Systematic Review.
Valizadeh A, Veenhuis RT, Bradley BA, Xu K. · · 2025 · PMID 40141240 · DOI 10.3390/ijms26062598

Verify or expand the search:

Other recruiting trials for HIV Infections

Currently open trials in the same condition.

NCT07225530 — Implementation of Screen, Treat, and Triage for Women Living With HIV in La Romana (iSTAR) · NA · recruiting
NCT07202546 — A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study) · Phase 2 · recruiting
NCT06694753 — Safety and Immunogenicity Study of Three mRNAs Encoding HIV Immunogens in Adult Participants Without HIV and in Overall · Phase 1 · recruiting
NCT07235852 — Pilot Testing Into the Feasibility of the Developed Cognitive Behavioral Therapy Intervention · NA · recruiting
NCT06665646 — Clinical Trial to Evaluate the Safety and Immunogenicity of Hiltonol, Poly-ICLC-adjuvanted CD40.HIVRI.Env (VRIPRO) in Ad · Phase 1 · recruiting

Other Montefiore Medical Center trials

Trials by the same sponsor.

NCT07224061 — Promoting Asthma Management Guidelines With Technology-Based Intervention and Care Coordination in Clinics and Schools · NA · not yet recruiting
NCT06775886 — Effect of Personalized Accelerated Pacing in Symptomatic Patients With Non-Obstructive Hypertrophic Cardiomyopathy · NA · terminated
NCT06919094 — A Virtual Life Story Club Intervention to Improve Loneliness and Apathy in Community-Dwelling Older Adults · NA · recruiting
NCT07076069 — The Effect of Multimodal Pain Regimen on Use of Narcotics After Rotator Cuff Tear Repair · Phase 4 · recruiting
NCT07037940 — Physician Response Evaluation With Contextual Insights vs. Standard Engines - Artificial Intelligence RAG vs LLM Clinica · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05554146 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Montefiore Medical Center
Last refreshed: 13 November 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05554146.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing