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Efficacy of Inhaled Cannabis in Diabetic Painful Peripheral Neuropathy

Primary Purpose

Painful Diabetic Neuropathy

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Cannabis

About this trial

This is an interventional treatment trial for Painful Diabetic Neuropathy focused on measuring neuropathic pain, diabetic neuropathy, cannabis, marijuana

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

UC San Diego, Hillcrest Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Arm Label

Arm Description

Placebo cannabis

Active cannabis - 1% THC by weight

Active cannabis - 4% THC by weight

Active cannabis - 7% THC by weight

Outcomes

Primary Outcome Measures

Spontaneous Pain Score

Secondary Outcome Measures

Acute sensory threshold

Experimental pain score

Cognitive testing

Subjective highness

Adverse events

Full Information

NCT ID

NCT00781001

First Posted

October 24, 2008

Last Updated

July 29, 2013

Sponsor

Center for Medicinal Cannabis Research

1. Study Identification

Unique Protocol Identification Number

NCT00781001

Brief Title

Efficacy of Inhaled Cannabis in Diabetic Painful Peripheral Neuropathy

Official Title

Efficacy of Inhaled Cannabis in Diabetic Painful Peripheral Neuropathy

Study Type

Interventional

2. Study Status

Record Verification Date

July 2013

Overall Recruitment Status

Completed

Study Start Date

July 2008 (undefined)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Center for Medicinal Cannabis Research

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Painful Diabetic Neuropathy

Keywords

neuropathic pain, diabetic neuropathy, cannabis, marijuana

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo cannabis

Arm Title

Arm Type

Experimental

Arm Description

Active cannabis - 1% THC by weight

Arm Title

Arm Type

Experimental

Arm Description

Active cannabis - 4% THC by weight

Arm Title

Arm Type

Experimental

Arm Description

Active cannabis - 7% THC by weight

Intervention Type

Drug

Intervention Name(s)

Cannabis

Intervention Description

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

Primary Outcome Measure Information:

Title

Spontaneous Pain Score

Time Frame

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

Secondary Outcome Measure Information:

Title

Acute sensory threshold

Time Frame

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

Title

Experimental pain score

Time Frame

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

Title

Cognitive testing

Time Frame

Baseline, 60, 120, 240 mins post-treatment

Title

Subjective highness

Time Frame

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

Title

Adverse events

Time Frame

Throughout the study

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark S Wallace, M.D.

Organizational Affiliation

University of California, San Diego

Official's Role

Principal Investigator

Facility Information:

Facility Name

UC San Diego, Hillcrest Medical Center

City

San Diego

State/Province

California

ZIP/Postal Code

92103

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.cmcr.ucsd.edu

Description

Center for Medicinal Cannabis Research

Learn more about this trial

Efficacy of Inhaled Cannabis in Diabetic Painful Peripheral Neuropathy

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