To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below.
Human Immunodeficiency Virus (HIV) - NORML - Working to Reform Marijuana Laws
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Search for terms x. Save this study. Warning You have reached the maximum number of saved studies Medicinal Cannabis for Painful HIV Neuropathy The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.
Marijuana Reduces HIV Neuropathy
Federal Government. Read our disclaimer for details. Last Update Posted : February 28, Study Description. The purpose of this study is to determine if medicinal cannabis marijuana is safe and effective for treating pain in individuals with HIV-associated distal, sensory-predominant polyneuropathy DSPN. FDA Resources. Arms and Interventions. Outcome Measures. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision.
Inclusion Criteria: Documented HIV infection Meets clinical and electrodiagnostic criteria for HIV-associated DSPN at entry Daily pain for at least three consecutive months with an average daily pain magnitude score of at least 5 on the Descriptor Differential Scale Inadequate pain relief with prior treatment for painful HIV neuropathy using drugs from at least two different classes of pain-modifying agents NSAIDS, low-potency opioids, high-potency opioids, sodium channel blockers, other adjunctive pain treatments Age years Stable use of opioid and non-opioid analgesic medications during the two weeks prior to study entry Exclusion Criteria: Positive urine toxicology screen for cannabinoids during the "wash-in" week prior to initiating study treatment Recent i.
Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials. University of California, San Diego.
After Day 2, patients treated with NGX experienced a progressive reduction in pain which was greater than that of patients in the control group from Day 5 through to Day 84 Figure 2 B. Pain reduction following a single 30 - minute application of NGX - B Daily analysis of mean change in NPRS score from baseline for the integrated minute treatment group. Patients treated with NGX showed a greater improvement in NPRS scores compared with those treated with control in all subgroups regardless of gender, baseline pain score, concomitant neuropathic pain medication use, and HIV-DSP duration Figure 3 and 4.
Mean percent change in NPRS score.
None of the reported SAEs was considered to be related to the study drug. NGX was well tolerated. Detailed tolerability assessments demonstrated that mean NPRS scores decreased slightly after application of the topical anesthetic and increased after patch application in all treatment groups. In the minute treatment group, mean NPRS scores increased to pre-topical anesthetic levels by 55 minutes post-patch application and remained at that pain level through 1 hour 55 minutes after patch removal; by contrast, the mean NPRS scores for the minute treatment group remained below pretreatment levels through 1 hour 55 minutes after patch removal data not shown.
The similarity of the demographic and baseline characteristics of the patients from the two multicenter, randomized, double-blind, controlled phase III studies Table 2 , together with comparable study designs, enrollment, and assessment criteria allowed data from the two studies to be combined. This measurement is recommended in chronic pain studies by the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials [ 25 ] and is more sensitive to treatment effects in neuropathic pain than pain intensity measurements [ 26 ].
Smoked Cannabis Reduces Foot Pain Associated With HIV In Placebo Trial
This is likely due to the large effects of the control patch observed in study C [ 23 ]. Interestingly, there was a significant improvement using the PGIC in the minute treatment compared with the control group. The data presented here show no evidence of increased efficacy with increased NGX treatment duration and support the selection of the minute dose for treatment of peripheral neuropathic pain in patients with HIV-associated neuropathy.
By contrast, for patients with post-herpetic neuralgia who typically experience neuropathic pain on the torso as opposed to the extremities, treatment duration is 60 minutes [ 27 , 28 ]. A transient increase in pain compared with baseline was seen on Day 0 in patients receiving NGX, due to the treatment procedure. Thereafter, NPRS scores in patients receiving a minute NGX application continued to decline and NGXtreated patients achieved a greater pain reduction than those in the control group by Day 5 and on each subsequent day through Day Weekly NPRS scores demonstrated significantly greater reductions in pain for NGXtreated patients compared with controls each week from Week 2 to study completion Week Subgroup analyses showed greater pain reduction in patients treated with NGX compared with those treated with control in all subgroups regardless of gender, baseline pain score, concomitant neuropathic pain medication, and HIV-DSP duration.
However, NGX was more effective in patients not using concomitant neuropathic pain medications compared with those using concomitant neuropathic pain medications. This result is not unexpected as it has been shown previously that the additional reduction of neuropathic pain obtained with an add-on drug is generally not as large as the benefit obtained with monotherapy [ 29 , 30 ].
This may be because some of the pathophysiologic mechanisms implicated in the generation and maintenance of neuropathic pain overlap or converge to a common pathway, resulting in a less than additive effect even for medications that act via different mechanistic pathways. Furthermore, patients already taking several concomitant neuropathic pain medications may be more treatment resistant or more difficult to treat. It is therefore important to note that a significant treatment effect was seen with NGX compared with control, despite two-thirds of the patients using concomitant neuropathic pain medication at study entry and during the study Table 2.
Gender, baseline pain score, and the duration of HIV-DSP did not influence NGX efficacy, indicating that pain relief can be achieved with NGX treatment even in those patients with high pain levels or long disease duration. Although NGX application does cause some treatment-related pain, it is generally mild or moderate and transient. Most common treatment-related AEs were application-site reactions; systemic effects were limited to small, transient elevations in mean systolic and diastolic blood pressure shortly after NGX application due to treatment-associated increases in pain.
In addition to its efficacy, there are few systemic AEs associated with NGX [ 31 ], unlike other available therapies, and repeated applications of NGX do not result in an increased incidence of application-site AEs, dermal irritation, intolerability, or impaired neurologic function [ 32 ]. Efficacy has been demonstrated when NGX is used alone as well as in combination with other systemic medications for neuropathic pain. Treatment with NGX neither increases the pill burden nor the potential for systemic drug—drug interactions, two important considerations for patients with HIV-DSP, who may already be taking several medications.
Details of each of the studies included in this analysis have been reported previously [ 22 , 23 ]. Patients taking other pain medications such as anticonvulsants, non-selective serotonin reuptake inhibitor non-SSRI antidepressants e. Exclusion criteria in both studies included the prior use of NGX and use of a topical medication on the painful area within 21 days before the NGX application day.
The control patch produced local erythema and a burning sensation to provide effective blinding in the studies. Patients were pre-treated with a topical local anesthetic cream L. Both the NGX and control patches were applied for 30, 60, or 90 minutes in study C [ 22 ] and for 30 or 60 minutes in study C [ 23 ]. After patch removal, the treatment area was cleansed with a proprietary cleansing gel NeurogesX, Inc.
A rapid-onset, opioid-based oral pain medication e. Following patch removal, local cooling could be used. Patients could also take a short-term regimen of an opioid-based oral pain medication e. Assessments were also carried out on the day of treatment Day 0 , at the termination visit Week 12 , and, depending on the study, at interim visits at Weeks 1 and 4 or 4 and 8 during the week blinded observation period.
The minute NGX dose was not included in these analyses as it was not evaluated in study C [ 23 ]. Intent-to-treat efficacy analyses consisted of all patients who received any study treatment and had at least 3 days of available NPRS scores during the baseline period. Changes in NPRS scores from baseline to Weeks 2—12 were compared between treatment groups using a pre-specified gender-stratified ANCOVA model with baseline pain score, pre-topical anesthetic pain score, and percent change in pain score after topical anesthetic treatment as covariates.
To avoid the potentially confounding effect of opioid medications allowed during Days 0—5, Week 1 NPRS scores were not included in the primary endpoint analysis. Missing post-treatment NPRS scores were imputed using a modified last observation carried forward approach. If the NPRS score was missing on post-treatment Days 0—8 or on Day 8 and one or more consecutive days, then the baseline score was imputed for those days.
If the NPRS score was missing for any day after Day 8, then the missing score was imputed by the last available non-imputed score recorded before that day. If all post-treatment NPRS scores were missing including Day 0 , all scores were imputed using the baseline score. For the weekly and the daily NPRS scores, missing scores were not imputed.
The percentages of patients reporting each level of dermal response were compared using the Cochran—Mantel—Haenszel test. Patients were analyzed as randomized for the efficacy analyses and as treated for the safety analyses. Mayo Clin Proc.
Neurol Clin. Lancet Neurol. Arch Neurol. AIDS clinical trial group protocol team. J Acquir Immune Defic Syndr. J Pain Symptom Manage. Am J Med. Clin J Pain. PLoS One. Annu Rev Neurosci. Pharmacol Rev. J Pain. N Engl J Med.
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