View Clinical Trial (Medical Research Study)
Efficacy of Inhaled Cannabis in Diabetic Painful Peripheral Neuropathy - NCT00781001-92103(Clinical Trial 249389)
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| City: |
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San Diego |
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State:
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CA |
| Zip Code: |
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92103 |
| Conditions: |
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Painful Diabetic Neuropathy |
| Purpose: |
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The purpose of this study is to determine if vaporized cannabis is effective as an analgesic
for the treatment of painful diabetic neuropathy.
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| Study summary: |
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Neuropathic pain is caused by an insult to the nervous system and accounts for 25-50% of all
pain clinic visits. Excluding low back pain, diabetic peripheral neuropathy is the most
common neuropathic pain syndrome with an estimated prevalence of 600,000 cases in the United
States. There are only 5 medications approved by the FDA for the treatment of neuropathic
pain with only 2 out of the 5 approved for the treatment of diabetic peripheral neuropathy.
Currently, there is a desperate need for more therapeutic agents for the treatment of
neuropathic pain. We propose to use painful diabetic peripheral neuropathy (DPN) patients to
study the efficacy of inhaled cannabis on neuropathic pain. We will enroll 20 subjects with
each subject acting as their own control; receiving both placebo and three doses of inhaled
aerosolized cannabis (low, medium, and high) in random order each separated by at least two
weeks. Subjects will be assessed for reduction in pain, changes in normal sensation, changes
in cognition, and effects of cannabis on experimentally induced pain. |
| Criteria: |
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Inclusion Criteria:
- Willing and able to provide informed consent
- History of diabetes mellitus type 1 or type 2 who have stable glycemia and are
maintained by diet or a stable regimen of diabetic therapy for at least 12 weeks
prior to screening
- Painful diabetic peripheral neuropathy for at least 6 months prior to screening with
symmetrical onset confirmed by neurological exam and a score of at least 3 on the
investigator section (physical exam) of the MNSI (Michigan Neuropathy Screening
Instrument) at screening.
- Subject has a pain rating of at least 4 on the 11 point Numeric Pain Scale.
- Patient is acceptable for enrollment as determined by the Investigator from the
medical history, physical exam finding, 12 lead ECG findings, and clinical laboratory
test results.
- HbA1C<11%.
- For female patients, a negative urine pregnancy test
Exclusion Criteria:
- Active opportunistic infections or opportunistic malignancies requiring acute
treatment
- Current or past cannabis abuse/dependence, or current other psychoactive drug use
disorder (e.g. opioids, methamphetamine, cocaine, alcohol)
- Presence of significant cardiac or pulmonary disease (e.g., tuberculosis, asthma)
- Pregnancy as ascertained by a self-report and a mandatory commercial pregnancy test
before any marijuana or placebo consumption condition.
- Current serious mental illness--e.g. bipolar disorder, schizophrenia, or other
psychotic disorder
- Other medical conditions that may lead to peripheral neuropathy
- Females who are pregnant or planning pregnancy.
- Females of child bearing potential not using a reliable means of birth control.
- Lower extremity amputations other than toes. Patients must not have phantom pain
from amputated toes.
- Other painful conditions or pain of vascular origin that may confound the assessment
of PDN.
- Subjects with unstable blood glucose level (Fasting< 70mg/dL or random blood glucose
level > 250 mg/dL) |
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| Study is available at: |
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UC San Diego, Hillcrest Medical Center
San Diego, CA 92103
United States
Primary Contact:
Katie Lam
Email: kklam@ucsd.edu
Phone: (858) 657-6125 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 22, 2011 |
Modifications to
this listing: |
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above to view all information about this clinical trial. |
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