Efficacy of Inhaled Cannabis in Diabetic Painful Peripheral Neuropathy

NCT00781001 | Completed Phase 1 DMC

• 1 other identifier: C06-SD-118
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Painful Diabetic Neuropathy

Keywords

neuropathic pain; diabetic neuropathy; cannabis; marijuana

Outcome Measures

Primary Outcomes (1)

• Spontaneous Pain Score

  Baseline, 5, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 mins post-treatment

Secondary Outcomes (5)

• Acute sensory threshold

  Baseline, 5, 30, 60, 90, 120, 150, 180, 210, 240 mins post-treatment

• Experimental pain score

  Baseline, 5, 30, 60, 90, 120, 150, 180, 210, 240 mins post-treatment

• Cognitive testing

  Baseline, 60, 120, 240 mins post-treatment

• Subjective highness

  Baseline, 30, 60, 90, 120, 240 mins post-treatment

• Adverse events

  Throughout the study

Study Arms (4)

1

PLACEBO COMPARATOR

Placebo cannabis

Drug: Cannabis

2

EXPERIMENTAL

Active cannabis - 1% THC by weight

Drug: Cannabis

3

EXPERIMENTAL

Active cannabis - 4% THC by weight

Drug: Cannabis

4

EXPERIMENTAL

Active cannabis - 7% THC by weight

Drug: Cannabis

Interventions

Cannabis DRUG

400mg placebo or active cannabis administered via the Volcano vaporizer 1x per study visit

1; 2; 3; 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Center for Medicinal Cannabis Research: lead

Study Sites (1)

UC San Diego, Hillcrest Medical Center

San Diego, California, 92103, United States

Location

Related Links

• Center for Medicinal Cannabis Research

MeSH Terms

Conditions

Diabetic Neuropathies; Neuralgia; Marijuana Abuse

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Mark S Wallace, M.D.

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2008
• First Posted: October 28, 2008
• Study Start: July 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: July 30, 2013

Record last verified: 2013-07

Locations

US (1)