Efficacy of Inhaled Cannabis in Diabetic Painful Peripheral Neuropathy

• Status: Completed
• Trial end date: 2011-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Center for Medicinal Cannabis Research

Criteria

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)