Efficacy of Inhaled Cannabis in Diabetic Painful Peripheral Neuropathy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Center for Medicinal Cannabis Research
ClinicalTrials.gov Identifier:
NCT00781001
First received: October 24, 2008
Last updated: July 29, 2013
Last verified: July 2013
  Purpose

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


Condition Intervention Phase
Painful Diabetic Neuropathy
Drug: Cannabis
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Inhaled Cannabis in Diabetic Painful Peripheral Neuropathy

Resource links provided by NLM:


Further study details as provided by Center for Medicinal Cannabis Research:

Primary Outcome Measures:
  • Spontaneous Pain Score [ Time Frame: Baseline, 5, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 mins post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Acute sensory threshold [ Time Frame: Baseline, 5, 30, 60, 90, 120, 150, 180, 210, 240 mins post-treatment ] [ Designated as safety issue: No ]
  • Experimental pain score [ Time Frame: Baseline, 5, 30, 60, 90, 120, 150, 180, 210, 240 mins post-treatment ] [ Designated as safety issue: No ]
  • Cognitive testing [ Time Frame: Baseline, 60, 120, 240 mins post-treatment ] [ Designated as safety issue: Yes ]
  • Subjective highness [ Time Frame: Baseline, 30, 60, 90, 120, 240 mins post-treatment ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]

Enrollment: 17
Study Start Date: July 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo cannabis
Drug: Cannabis
400mg placebo or active cannabis administered via the Volcano vaporizer 1x per study visit
Experimental: 2
Active cannabis - 1% THC by weight
Drug: Cannabis
400mg placebo or active cannabis administered via the Volcano vaporizer 1x per study visit
Experimental: 3
Active cannabis - 4% THC by weight
Drug: Cannabis
400mg placebo or active cannabis administered via the Volcano vaporizer 1x per study visit
Experimental: 4
Active cannabis - 7% THC by weight
Drug: Cannabis
400mg placebo or active cannabis administered via the Volcano vaporizer 1x per study visit

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00781001

Locations
United States, California
UC San Diego, Hillcrest Medical Center
San Diego, California, United States, 92103
Sponsors and Collaborators
Center for Medicinal Cannabis Research
Investigators
Principal Investigator: Mark S Wallace, M.D. University of California, San Diego
  More Information

Additional Information:
No publications provided

Responsible Party: Center for Medicinal Cannabis Research
ClinicalTrials.gov Identifier: NCT00781001     History of Changes
Other Study ID Numbers: C06-SD-118
Study First Received: October 24, 2008
Last Updated: July 29, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Center for Medicinal Cannabis Research:
neuropathic pain
diabetic neuropathy
cannabis
marijuana

Additional relevant MeSH terms:
Diabetic Neuropathies
Marijuana Abuse
Pain
Peripheral Nervous System Diseases
Demyelinating Diseases
Polyneuropathies
Nerve Compression Syndromes
Neurologic Manifestations
Neurotoxicity Syndromes
Neuromuscular Diseases
Nervous System Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Substance-Related Disorders
Mental Disorders
Signs and Symptoms
Poisoning

ClinicalTrials.gov processed this record on April 17, 2014