Painful Diabetic NeuropathyPhase 1/2NCT00781001
Efficacy of Inhaled Cannabis in Diabetic Painful Peripheral Neuropathy
A Phase 1/2 study testing Cannabis in people with Painful Diabetic Neuropathy, run by Center for Medicinal Cannabis Research at 1 site in United States.
Trial summary
The purpose of this study is to determine if vaporized cannabis is effective as an analgesic for the treatment of painful diabetic neuropathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Painful Diabetic Neuropathy
- What is being tested?
- Cannabis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Jun 2011
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
UC San Diego, Hillcrest Medical Center
San Diego, California, 92103
About this study
The purpose of this study is to determine if vaporized cannabis is effective as an analgesic for the treatment of painful diabetic neuropathy.
Read the 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.
- Conditions
- Painful Diabetic Neuropathy
- Being tested
- Cannabis
- Keywords
- neuropathic pain, diabetic neuropathy, cannabis, marijuana
- Medical subject headings
- Diabetic Neuropathies, Neuralgia, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabisDrug
400mg placebo or active cannabis administered via the Volcano vaporizer 1x per study visit
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Placebo cannabis Receives: Drug: Cannabis |
| 2 | Experimental | Active cannabis - 1% THC by weight Receives: Drug: Cannabis |
| 3 | Experimental | Active cannabis - 4% THC by weight Receives: Drug: Cannabis |
| 4 | Experimental | Active cannabis - 7% THC by weight Receives: Drug: Cannabis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spontaneous Pain Score
Measured: Baseline, 5, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 mins post-treatment
Secondary outcomes (5)
Acute sensory threshold
Measured: Baseline, 5, 30, 60, 90, 120, 150, 180, 210, 240 mins post-treatment
Experimental pain score
Measured: Baseline, 5, 30, 60, 90, 120, 150, 180, 210, 240 mins post-treatment
Cognitive testing
Measured: Baseline, 60, 120, 240 mins post-treatment
Subjective highness
Measured: Baseline, 30, 60, 90, 120, 240 mins post-treatment
Adverse events
Measured: Throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2008 (estimated)
- Study startJul 2008
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Painful Diabetic NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Medicinal Cannabis Research
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark S Wallace, M.D., Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00781001
- Sponsor's protocol ID
- C06-SD-118
- Status last verified
- Jul 2013
- First submitted
- 24 Oct 2008
- Last updated
- 30 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Inhaled Cannabis in Diabetic Painful Peripheral Neuropathy
- ClinicalTrials.gov ID
- NCT00781001
- Acronym / sponsor ID
- C06-SD-118
- Conditions
- Painful Diabetic Neuropathy
- Keywords
- neuropathic pain, diabetic neuropathy, cannabis, marijuana
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Center for Medicinal Cannabis ResearchUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 28 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: CannabisPlacebo cannabis |
| 2 | Experimental | Drug: CannabisActive cannabis - 1% THC by weight |
| 3 | Experimental | Drug: CannabisActive cannabis - 4% THC by weight |
| 4 | Experimental | Drug: CannabisActive cannabis - 7% THC by weight |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cannabis400mg placebo or active cannabis administered via the Volcano vaporizer 1x per study visit | Drug | 1, 2, 3, 4 |
Primary outcome
Spontaneous Pain Score
Time frame: Baseline, 5, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 mins post-treatment
5 secondary outcomes
Acute sensory threshold
Time frame: Baseline, 5, 30, 60, 90, 120, 150, 180, 210, 240 mins post-treatment
Experimental pain score
Time frame: Baseline, 5, 30, 60, 90, 120, 150, 180, 210, 240 mins post-treatment
Cognitive testing
Time frame: Baseline, 60, 120, 240 mins post-treatment
Subjective highness
Time frame: Baseline, 30, 60, 90, 120, 240 mins post-treatment
Adverse events
Time frame: Throughout the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2013.
- Center for Medicinal Cannabis ResearchLink provided by the sponsor.
Related trials for Painful Diabetic Neuropathy
Recruiting
Effect of 4-7-8 Breathing Technique on Pain and Anxiety During Electromyography in Diabetic Neuropathy
Diabetic Neuropathies, Diabetes Mellitus (Type 2)
Active, not recruiting
Comparative Effects of tDCS and tACS on Pain, Dexterity, and Strength in Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy (DPN)
RecruitingObservational study
Safety and Effect of Peripheral Nerve Decompression Combined With Peripheral Nerve Stimulation for Painful Diabetic Peripheral Neuropathy
Painful Diabetic Peripheral Neuropathy, Diabetes Complication
Active, not recruitingPhase 3
Evaluation of the Long-term Safety and Effectiveness of Suzetrigine (SUZ) in Participants With Painful Diabetic Peripheral Neuropathy (DPN)
Diabetic Peripheral Neuropathic Pain
Not yet recruitingPhase 4
Modality Choice Before and After Failure for the Treatment of Painful Diabetic Neuropathy
Painful Diabetic Neuropathy (PDN), Diabetic Nephropathies
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark S Wallace, M.D. principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cannabis in people with Painful Diabetic Neuropathy, run by Center for Medicinal Cannabis Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spontaneous Pain Score (time frame: Baseline, 5, 15, 30, 45, 60, 90, 120, 150, 180, 210, 240 mins post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2013.