Efficacy of Inhaled Cannabis in Diabetic Painful Peripheral Neuropathy

Completed · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Painful Diabetic Neuropathy

In brief

The purpose of this study is to determine if vaporized cannabis is effective as an analgesic for the treatment of painful diabetic neuropathy.

Key facts

Study ID

NCT00781001

Run by

Center for Medicinal Cannabis Research

People needed

17

Starts

2008-07-01

Expected to finish

2011-06-01

Last updated by the study team

2013-07-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• UC San Diego, Hillcrest Medical Center — San Diego, California, United States

Full record on ClinicalTrials.gov

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