HIV InfectionsPITCH-ENCT05554146
Pain Inflammation and Cannabis in HIV
A study testing Receipt of Coupon for High THC Soft-Gel Capsule, Receipt of Coupon for Equal THC and CBD Soft-Gel Capsule and Receipt of Coupon for High CBD Soft-Gel Capsule in people with HIV Infections and Neuropathic Pain, run by Montefiore Medical Center at 1 site in United States.
Trial 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 tetrahydrocannabinol (THC) and cannabidiol (CBD) in medical cannabis impact neuropathic pain… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- HIV Infections, Neuropathic Pain, Cannabis
- What is being tested?
- Receipt of Coupon for High THC Soft-Gel Capsule, Receipt of Coupon for Equal THC and CBD Soft-Gel Capsule and Receipt of Coupon for High CBD Soft-Gel Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2022to 3 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ->=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
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Medical Cannabis on Pain and Inflammation in People Living With HIV
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.
Read the 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.
- Conditions
- HIV Infections, Neuropathic Pain, Cannabis
- Being 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
- Medical subject headings
- HIV Infections, Neuralgia, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Receipt of Coupon for Placebo Soft-Gel CapsuleOther
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
Placebo (0:0) Softgel, 0mg THC and 0mg CBD per cap, Bottle of 30 caps
Receipt of Coupon for High THC Soft-Gel CapsuleOther
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
Vireo Yellow (6:1) Softgel, 4.29mg THC and 0.72mg CBD per cap, Bottle of 30 caps
Receipt of Coupon for Equal THC and CBD Soft-Gel CapsuleOther
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
Vireo Green (1:1) Softgel, 2.5mg THC and 2.5mg CBD per cap, Bottle of 30 caps
Receipt of Coupon for High CBD Soft-Gel CapsuleOther
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
Vireo Indigo (1:19) Softgel, 0.25mg THC and 4.75mg CBD per cap, Bottle of 30 caps
| Study group | Role | What they receive |
|---|---|---|
| Coupon for a Discounted Placebo Product | Other | We will observe participants who were previously randomized to a coupon for discounted placebo soft-gel capsules by our collaborators, Vireo. Receives: Other: Receipt of Coupon for Placebo Soft-Gel Capsule |
| Coupon for a Discounted High THC Product | Other | We will observe participants who were previously randomized to a coupon for discounted 4.29 mg THC/0.72 mg CBD soft-gel capsules by our collaborators, Vireo. Receives: Other: Receipt of Coupon for High THC Soft-Gel Capsule |
| Coupon for a Discounted Equal THC and CBD Product | Other | 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. Receives: Other: Receipt of Coupon for Equal THC and CBD Soft-Gel Capsule |
| Coupon for a Discounted High CBD Product | Other | We will observe participants who were previously randomized to a coupon for discounted 0.25 mg THC/4.75 mg CBD soft-gel capsules by our collaborators, Vireo. Receives: Other: Receipt of Coupon for High CBD Soft-Gel Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Severity Score
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 weeks following intervention were summarized and reported with positive values being indicative of increased pain severity compared to baseline and negative values being indicative of decreased pain severity compared to baseline.
Measured: At weekly intervals from Baseline to 14 weeks
Secondary outcomes (8)
Change in Circulating Levels of Anti-inflammatory Cytokines - Interleukin-10 (IL-10)
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 intervention were summarized and reported. Samples were collected at two time points prior to the intervention and the results from these analyses were averaged and compared to the 14-week results.
Measured: From Baseline to 14 weeks
Change in Circulating Levels of Anti-inflammatory Cytokines - Interleukin-4 (IL-4)
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 intervention were summarized and reported. Samples were collected at two time points prior to the intervention and the results from these analyses were averaged and compared to the 14-week results.
Measured: From Baseline to 14 weeks
Change in Circulating Levels of Pro-inflammatory Cytokines - Tumor Necrosis Factor Alpha (TNFa)
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 intervention were summarized and reported. Samples were collected at two time points prior to the intervention and the results from these analyses were averaged and compared to the 14-week results.
Measured: From Baseline to 14 weeks
Change in Circulating Levels of Pro-inflammatory Cytokines - Interleukin-6 (IL-6)
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 intervention were summarized and reported. Samples were collected at two time points prior to the intervention and the results from these analyses were averaged and compared to the 14-week results.
Measured: From Baseline to 14 weeks
Change in Antiretroviral Medication Adherence Score
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 was taken. Higher scores were indicative of increased medication adherence. Scores were summarized by study arm. For purposes of this study change in antiretroviral adherence score from baseline to 14 weeks following intervention was summarized and reported. Positive values are indicative of increased medication adherence from baseline and negative values are indicative of decreased adherence.
Measured: From Baseline to 14 weeks
Change in HIV Viral Load Suppression
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 values are indicative of decreased/suppressed HIV viral load levels compared to baseline. A high HIV viral load in the blood is associated with increased risk of disease progression and HIV transmission.
Measured: From Baseline to 14 weeks
Change in Depression Score
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 being indicative of increased severity/frequency of depressive symptoms. For purposes of this study change in depression score from baseline to 14 weeks following intervention was summarized. Positive values are indicative of increased depressive symptom severity/frequency compared to baseline and negative values are indicative of decreased depressive symptom severity/frequency compared to baseline.
Measured: From Baseline to 14 weeks
Change in Anxiety Score
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 purposes of this study change in anxiety score from baseline to 14 weeks following intervention was summarized and reported. Positive values are indicative of increased anxiety symptoms compared to baseline and negative values are indicative of decreased anxiety symptoms compared to baseline.
Measured: From Baseline to 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2022
- Study start28 Oct 2022
- Primary completion3 May 2024
- Study completion3 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by Montefiore Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- We will observe participants who are enrolled in one of 4 arms in a partnering study over 14 weeks.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montefiore Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), University of Colorado, Boulder, University of Pittsburgh, Vireo Health
- Responsible party
- Sponsor
- Investigators
- Deepika E Slawek, MD, MPH, MS, Principal investigator, Montefiore Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05554146
- Sponsor's protocol ID
- 2021-13662
- Other IDs
- K23DA053997
- Acronym
- PITCH-E
- Status last verified
- Oct 2025
- First submitted
- 21 Sep 2022
- Last updated
- 13 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
National Conference of State Legislatures. State Medical Marijuana Laws. Published 2020. Updated 11/6/2020.
New York State Department of Health. Medical Use of Marijuana Under the Compassionate Care Act. In. Vol 22018.
Russo E, Guy GW. A tale of two cannabinoids: the therapeutic rationale for combining tetrahydrocannabinol and cannabidiol. Med Hypotheses. 2006;66(2):234-46. doi: 10.1016/j.mehy.2005.08.026. Epub 2005 Oct 4.
PubMed 16209908Merlin JS, Cen L, Praestgaard A, Turner M, Obando A, Alpert C, Woolston S, Casarett D, Kostman J, Gross R, Frank I. Pain and physical and psychological symptoms in ambulatory HIV patients in the current treatment era. J Pain Symptom Manage. 2012 Mar;43(3):638-45. doi: 10.1016/j.jpainsymman.2011.04.019. Epub 2011 Nov 23.
PubMed 22115794Newshan G, Bennett J, Holman S. Pain and other symptoms in ambulatory HIV patients in the age of highly active antiretroviral therapy. J Assoc Nurses AIDS Care. 2002 Jul-Aug;13(4):78-83. doi: 10.1016/S1055-3290(06)60373-7.
PubMed 12149887Harding R, Lampe FC, Norwood S, Date HL, Clucas C, Fisher M, Johnson M, Edwards S, Anderson J, Sherr L. Symptoms are highly prevalent among HIV outpatients and associated with poor adherence and unprotected sexual intercourse. Sex Transm Infect. 2010 Dec;86(7):520-4. doi: 10.1136/sti.2009.038505. Epub 2010 Jun 15.
PubMed 20551235Silverberg MJ, Jacobson LP, French AL, Witt MD, Gange SJ. Age and racial/ethnic differences in the prevalence of reported symptoms in human immunodeficiency virus-infected persons on antiretroviral therapy. J Pain Symptom Manage. 2009 Aug;38(2):197-207. doi: 10.1016/j.jpainsymman.2008.08.007. Epub 2009 Mar 28.
PubMed 19329274Cervia LD, McGowan JP, Weseley AJ. Clinical and demographic variables related to pain in HIV-infected individuals treated with effective, combination antiretroviral therapy (cART). Pain Med. 2010 Apr;11(4):498-503. doi: 10.1111/j.1526-4637.2010.00802.x. Epub 2010 Mar 4.
PubMed 20210870Lee KA, Gay C, Portillo CJ, Coggins T, Davis H, Pullinger CR, Aouizerat BE. Symptom experience in HIV-infected adults: a function of demographic and clinical characteristics. J Pain Symptom Manage. 2009 Dec;38(6):882-93. doi: 10.1016/j.jpainsymman.2009.05.013.
PubMed 19811886Merlin JS, Westfall AO, Raper JL, Zinski A, Norton WE, Willig JH, Gross R, Ritchie CS, Saag MS, Mugavero MJ. Pain, mood, and substance abuse in HIV: implications for clinic visit utilization, antiretroviral therapy adherence, and virologic failure. J Acquir Immune Defic Syndr. 2012 Oct 1;61(2):164-70. doi: 10.1097/QAI.0b013e3182662215.
PubMed 22766967Miaskowski C, Penko JM, Guzman D, Mattson JE, Bangsberg DR, Kushel MB. Occurrence and characteristics of chronic pain in a community-based cohort of indigent adults living with HIV infection. J Pain. 2011 Sep;12(9):1004-16. doi: 10.1016/j.jpain.2011.04.002.
PubMed 21684218Bruce RD, Merlin J, Lum PJ, Ahmed E, Alexander C, Corbett AH, Foley K, Leonard K, Treisman GJ, Selwyn P. 2017 HIV Medicine Association of Infectious Diseases Society of America Clinical Practice Guideline for the Management of Chronic Pain in Patients Living With Human Immunodeficiency Virus. Clin Infect Dis. 2017 Oct 30;65(10):1601-1606. doi: 10.1093/cid/cix848.
PubMed 29091230Phillips TJC, Brown M, Ramirez JD, Perkins J, Woldeamanuel YW, Williams ACC, Orengo C, Bennett DLH, Bodi I, Cox S, Maier C, Krumova EK, Rice ASC. Sensory, psychological, and metabolic dysfunction in HIV-associated peripheral neuropathy: A cross-sectional deep profiling study. Pain. 2014 Sep;155(9):1846-1860. doi: 10.1016/j.pain.2014.06.014. Epub 2014 Jun 26.
PubMed 24973717Merlin JS. Chronic Pain in Patients With HIV Infection: What Clinicians Need To Know. Top Antivir Med. 2015 Aug-Sep;23(3):120-4.
PubMed 26518396Van der Watt JJ, Wilkinson KA, Wilkinson RJ, Heckmann JM. Plasma cytokine profiles in HIV-1 infected patients developing neuropathic symptoms shortly after commencing antiretroviral therapy: a case-control study. BMC Infect Dis. 2014 Feb 10;14:71. doi: 10.1186/1471-2334-14-71.
PubMed 24512313
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Medical Cannabis on Pain and Inflammation in People Living With HIV
- ClinicalTrials.gov ID
- NCT05554146
- Acronym / sponsor ID
- PITCH-E / 2021-13662
- Conditions
- HIV Infections, Neuropathic Pain, Cannabis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Montefiore Medical CenterUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), University of Colorado, Boulder, University of Pittsburgh, Vireo Health
- Study start
- 28 Oct 2022 (actual)
- Primary completion
- 3 May 2024 (actual)
- Study completion
- 3 May 2024 (actual)
- First posted
- 26 Sep 2022 (actual)
- Results
- Posted 13 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- We will observe participants who are enrolled in one of 4 arms in a partnering study over 14 weeks.
| Arm | Type | Receives |
|---|---|---|
| Coupon for a Discounted Placebo Product | Other | Other: Receipt of Coupon for Placebo Soft-Gel CapsuleWe will observe participants who were previously randomized to a coupon for discounted placebo soft-gel capsules by our collaborators, Vireo. |
| Coupon for a Discounted High THC Product | Other | Other: Receipt of Coupon for High THC Soft-Gel CapsuleWe will observe participants who were previously randomized to a coupon for discounted 4.29 mg THC/0.72 mg CBD soft-gel capsules by our collaborators, Vireo. |
| Coupon for a Discounted Equal THC and CBD Product | Other | Other: Receipt of Coupon for Equal THC and CBD Soft-Gel CapsuleWe 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. |
| Coupon for a Discounted High CBD Product | Other | Other: Receipt of Coupon for High CBD Soft-Gel CapsuleWe will observe participants who were previously randomized to a coupon for discounted 0.25 mg THC/4.75 mg CBD soft-gel capsules by our collaborators, Vireo. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ->=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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Receipt of Coupon for Placebo Soft-Gel CapsuleThe 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 Placebo (0:0) Softgel, 0mg THC and 0mg CBD per cap, Bottle of 30 caps | Other | Coupon for a Discounted Placebo Product |
| Receipt of Coupon for High THC Soft-Gel CapsuleThe 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 Vireo Yellow (6:1) Softgel, 4.29mg THC and 0.72mg CBD per cap, Bottle of 30 caps | Other | Coupon for a Discounted High THC Product |
| Receipt of Coupon for Equal THC and CBD Soft-Gel CapsuleThe 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 Vireo Green (1:1) Softgel, 2.5mg THC and 2.5mg CBD per cap, Bottle of 30 caps | Other | Coupon for a Discounted Equal THC and CBD Product |
| Receipt of Coupon for High CBD Soft-Gel CapsuleThe 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 Vireo Indigo (1:19) Softgel, 0.25mg THC and 4.75mg CBD per cap, Bottle of 30 caps | Other | Coupon for a Discounted High CBD Product |
Primary outcome
Change in Pain Severity Score
Time frame: 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 weeks following intervention were summarized and reported with positive values being indicative of increased pain severity compared to baseline and negative values being indicative of decreased pain severity compared to baseline.
8 secondary outcomes
Change in Circulating Levels of Anti-inflammatory Cytokines - Interleukin-10 (IL-10)
Time frame: From Baseline to 14 weeks
Change in Circulating Levels of Anti-inflammatory Cytokines - Interleukin-4 (IL-4)
Time frame: From Baseline to 14 weeks
Change in Circulating Levels of Pro-inflammatory Cytokines - Tumor Necrosis Factor Alpha (TNFa)
Time frame: From Baseline to 14 weeks
Change in Circulating Levels of Pro-inflammatory Cytokines - Interleukin-6 (IL-6)
Time frame: From Baseline to 14 weeks
Change in Antiretroviral Medication Adherence Score
Time frame: From Baseline to 14 weeks
Change in HIV Viral Load Suppression
Time frame: From Baseline to 14 weeks
Change in Depression Score
Time frame: From Baseline to 14 weeks
Change in Anxiety Score
Time frame: From Baseline to 14 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundNational Conference of State Legislatures. State Medical Marijuana Laws. Published 2020. Updated 11/6/2020.
- BackgroundNew York State Department of Health. Medical Use of Marijuana Under the Compassionate Care Act. In. Vol 22018.
- Background: PubMed 16209908Russo E, Guy GW. A tale of two cannabinoids: the therapeutic rationale for combining tetrahydrocannabinol and cannabidiol. Med Hypotheses. 2006;66(2):234-46. doi: 10.1016/j.mehy.2005.08.026. Epub 2005 Oct 4.
- Background: PubMed 22115794Merlin JS, Cen L, Praestgaard A, Turner M, Obando A, Alpert C, Woolston S, Casarett D, Kostman J, Gross R, Frank I. Pain and physical and psychological symptoms in ambulatory HIV patients in the current treatment era. J Pain Symptom Manage. 2012 Mar;43(3):638-45. doi: 10.1016/j.jpainsymman.2011.04.019. Epub 2011 Nov 23.
- Background: PubMed 12149887Newshan G, Bennett J, Holman S. Pain and other symptoms in ambulatory HIV patients in the age of highly active antiretroviral therapy. J Assoc Nurses AIDS Care. 2002 Jul-Aug;13(4):78-83. doi: 10.1016/S1055-3290(06)60373-7.
- Background: PubMed 20551235Harding R, Lampe FC, Norwood S, Date HL, Clucas C, Fisher M, Johnson M, Edwards S, Anderson J, Sherr L. Symptoms are highly prevalent among HIV outpatients and associated with poor adherence and unprotected sexual intercourse. Sex Transm Infect. 2010 Dec;86(7):520-4. doi: 10.1136/sti.2009.038505. Epub 2010 Jun 15.
- Background: PubMed 19329274Silverberg MJ, Jacobson LP, French AL, Witt MD, Gange SJ. Age and racial/ethnic differences in the prevalence of reported symptoms in human immunodeficiency virus-infected persons on antiretroviral therapy. J Pain Symptom Manage. 2009 Aug;38(2):197-207. doi: 10.1016/j.jpainsymman.2008.08.007. Epub 2009 Mar 28.
- Background: PubMed 20210870Cervia LD, McGowan JP, Weseley AJ. Clinical and demographic variables related to pain in HIV-infected individuals treated with effective, combination antiretroviral therapy (cART). Pain Med. 2010 Apr;11(4):498-503. doi: 10.1111/j.1526-4637.2010.00802.x. Epub 2010 Mar 4.
- Background: PubMed 19811886Lee KA, Gay C, Portillo CJ, Coggins T, Davis H, Pullinger CR, Aouizerat BE. Symptom experience in HIV-infected adults: a function of demographic and clinical characteristics. J Pain Symptom Manage. 2009 Dec;38(6):882-93. doi: 10.1016/j.jpainsymman.2009.05.013.
- Background: PubMed 22766967Merlin JS, Westfall AO, Raper JL, Zinski A, Norton WE, Willig JH, Gross R, Ritchie CS, Saag MS, Mugavero MJ. Pain, mood, and substance abuse in HIV: implications for clinic visit utilization, antiretroviral therapy adherence, and virologic failure. J Acquir Immune Defic Syndr. 2012 Oct 1;61(2):164-70. doi: 10.1097/QAI.0b013e3182662215.
- Background: PubMed 21684218Miaskowski C, Penko JM, Guzman D, Mattson JE, Bangsberg DR, Kushel MB. Occurrence and characteristics of chronic pain in a community-based cohort of indigent adults living with HIV infection. J Pain. 2011 Sep;12(9):1004-16. doi: 10.1016/j.jpain.2011.04.002.
- Background: PubMed 29091230Bruce RD, Merlin J, Lum PJ, Ahmed E, Alexander C, Corbett AH, Foley K, Leonard K, Treisman GJ, Selwyn P. 2017 HIV Medicine Association of Infectious Diseases Society of America Clinical Practice Guideline for the Management of Chronic Pain in Patients Living With Human Immunodeficiency Virus. Clin Infect Dis. 2017 Oct 30;65(10):1601-1606. doi: 10.1093/cid/cix848.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deepika E Slawek, MD, MPH, MS principal investigator
Montefiore Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Receipt of Coupon for High THC Soft-Gel Capsule, Receipt of Coupon for Equal THC and CBD Soft-Gel Capsule and Receipt of Coupon for High CBD Soft-Gel Capsule in people with HIV Infections and Neuropathic Pain, run by Montefiore Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Severity Score (time frame: At weekly intervals from Baseline to 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05554146, which also lists 36 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2025.