Status:
COMPLETED
Efficacy of Inhaled Cannabis in Diabetic Painful Peripheral Neuropathy
Lead Sponsor:
Center for Medicinal Cannabis Research
Conditions:
Painful Diabetic Neuropathy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to determine if vaporized cannabis is effective as an analgesic for the treatment of painful diabetic neuropathy.
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00781001
Start Date
July 1 2008
End Date
June 1 2011
Last Update
July 30 2013
Active Locations (1)
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1
UC San Diego, Hillcrest Medical Center
San Diego, California, United States, 92103