Neuropathic PainPhase 1/2NCT01037088

Effects of Vaporized Marijuana on Neuropathic Pain

A Phase 1/2 study testing Mild dose cannabis, Low dose cannabis and Cannabis in people with Neuropathic Pain and Reflex Sympathetic Dystrophy, run by University of California, Davis at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study theorized that a low dose of vaporized cannabis could alleviate nerve injury pain. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Neuropathic Pain, Reflex Sympathetic Dystrophy, Peripheral Neuropathy
What is being tested?: Mild dose cannabis, Low dose cannabis and Cannabis
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 44 participants
Where: 1 siteUnited States
Study dates: Dec 2009to Nov 2012
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age greater than 18 and less than 70
Visual Analogue Scale (VAS pain intensity) greater than 3/10
A negative urine drug screening test, i.e., no evidence of IV drug abuse
Neuropathic pain due to reflex sympathetic dystrophy, peripheral neuropathy, post-herpetic neuralgia, post-stroke pain, multiple sclerosis or spinal cord injury

Who cannot join

Presence of another painful condition of greater severity than the neuropathic pain condition which is being studied.
Subjects with moderate-severe major depression, bipolar/mania, bipolar II/hypomania and schizophrenia or schizoaffective disorder.
Unstable Type 1 or 2 diabetes defined as blood glucose more than 156 mg/dl
History of traumatic brain injury
Uncontrolled medical condition, including coronary artery disease, hypertension, cerebrovascular disease, asthma, tuberculosis (TB), chronic obstructive pulmonary disease (COPD), opportunistic infection, malignancy requiring active treatment, active substance abuse (alcohol or injection drugs).
Current use of marijuana (e.g., within 30 days of randomization)
Pregnancy as ascertained by a self-report and a mandatory commercial pregnancy test.

Trial locations and contacts

1 site in 1 country.

United States1 site

CTSC Clinical Research Center, Sacramento VA Medical Center
Sacramento, California, 95817

Other trials in United States

About this study

Official title: CCRC: The Analgesic Effect of Vaporized Cannabis on Neuropathic Pain

This study theorized that a low dose of vaporized cannabis could alleviate nerve injury pain.

Read the detailed description

We conducted a double-blind, placebo-controlled, crossover study evaluating the analgesic efficacy of vaporized cannabis in subjects, the majority of whom were experiencing neuropathic pain despite traditional treatment. Thirty-nine patients with central and peripheral neuropathic pain underwent a standardized procedure for inhaling medium-dose (3.53%), low-dose (1.29%), or placebo cannabis with the primary outcome being visual analog scale pain intensity. Psychoactive side effects and neuropsychological performance were also evaluated.

Conditions: Neuropathic Pain, Reflex Sympathetic Dystrophy, Peripheral Neuropathy, Post-herpetic Neuralgia, Spinal Cord Injury, Multiple Sclerosis
Being tested: Mild dose cannabis, Low dose cannabis, Cannabis
Keywords: cannabis, marijuana, neuropathy, antinociception, mood, cognition, neuropathic pain
Medical subject headings: Neuralgia, Reflex Sympathetic Dystrophy, Peripheral Nervous System Diseases, Neuralgia, Postherpetic, Spinal Cord Injuries, Multiple Sclerosis, Marijuana Abuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mild dose cannabisDrug
Also called marijuana
3.53% THC by weight
Low dose cannabisDrug
Also called marijuana
1.29% THC by weight
CannabisDrug
Also called placebo marijuana
0.00% THC by weight

Study groups in NCT01037088
Study group	Role	What they receive
Mild dose cannabis	Experimental	3.53% THC by weight Receives: Drug: Mild dose cannabis
Low dose cannabis	Experimental	1.29% THC by weight Receives: Drug: Low dose cannabis
Placebo cannabis	Placebo comparator	placebo marijuana Receives: Drug: Cannabis

What is being measured

The primary outcome is the main question the study is designed to answer.

Participants With 30% or Greater Reduction in Pain Intensity
The primary outcome variable, VAS Pain Intensity, was assessed by asking participants to indicate the intensity of their current pain on a 100-mm visual analog scale (VAS) between 0 (no pain) and 100 (worst possible pain).An assessment was performed before the administration of vaporized cannabis or placebo and hourly thereafter for six hours.
Measured: baseline to six hours

Secondary outcomes (1)

Visual Analogue Scale Pain Intensity Scores for Baseline and up to 5 Hours Following Administration of Vaporized Cannabis
The pain intensity scores for all of the time points (i.e., baseline prior to administration and up to 5 hours following administration of cannabis). VAS Pain Intensity was assessed by asking participants to indicate the intensity of their current pain on a 100-mm visual analog scale (VAS) between 0 (no pain) and 100 (worst possible pain).
Measured: baseline to six hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2009Nov 2012

First posted21 Dec 2009 (estimated)
Study startDec 2009
Primary completionNov 2012
Study completionNov 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Neuropathic PainStudies of the same condition, open and under way.
More trials run by University of California, DavisThe sponsor's other registered studies.
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: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01037088
Sponsor's protocol ID: 200614658
Other IDs: C06-DA-119
Status last verified: Oct 2017
First submitted: 17 Dec 2009
Last updated: 31 Jan 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Wilsey B, Marcotte T, Tsodikov A, Millman J, Bentley H, Gouaux B, Fishman S. A randomized, placebo-controlled, crossover trial of cannabis cigarettes in neuropathic pain. J Pain. 2008 Jun;9(6):506-21. doi: 10.1016/j.jpain.2007.12.010. Epub 2008 Apr 10.
PubMed 18403272

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Neuropathic Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: CCRC: The Analgesic Effect of Vaporized Cannabis on Neuropathic Pain
ClinicalTrials.gov ID: NCT01037088
Acronym / sponsor ID: 200614658
Conditions: Neuropathic Pain, Reflex Sympathetic Dystrophy, Peripheral Neuropathy, Post-herpetic Neuralgia, Spinal Cord Injury, Multiple Sclerosis
Keywords: cannabis, marijuana, neuropathy, antinociception, mood, cognition, neuropathic pain
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: University of California, DavisUniversity, hospital or other
Collaborators: Center for Medicinal Cannabis Research, VA Northern California Health Care System
Study start: Dec 2009
Primary completion: Nov 2012 (actual)
Study completion: Nov 2012 (actual)
First posted: 21 Dec 2009 (estimated)
Results: Posted 9 Apr 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study theorized that a low dose of vaporized cannabis could alleviate nerve injury pain.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Mild dose cannabis	Experimental	Drug: Mild dose cannabis3.53% THC by weight
Low dose cannabis	Experimental	Drug: Low dose cannabis1.29% THC by weight
Placebo cannabis	Placebo comparator	Drug: Cannabisplacebo marijuana

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Age greater than 18 and less than 70
Visual Analogue Scale (VAS pain intensity) greater than 3/10
A negative urine drug screening test, i.e., no evidence of IV drug abuse
Neuropathic pain due to reflex sympathetic dystrophy, peripheral neuropathy, post-herpetic neuralgia, post-stroke pain, multiple sclerosis or spinal cord injury

Key exclusion criteria (7 listed)

Presence of another painful condition of greater severity than the neuropathic pain condition which is being studied.
Subjects with moderate-severe major depression, bipolar/mania, bipolar II/hypomania and schizophrenia or schizoaffective disorder.
Unstable Type 1 or 2 diabetes defined as blood glucose more than 156 mg/dl
History of traumatic brain injury
Uncontrolled medical condition, including coronary artery disease, hypertension, cerebrovascular disease, asthma, tuberculosis (TB), chronic obstructive pulmonary disease (COPD), opportunistic infection, malignancy requiring active treatment, active substance abuse (alcohol or injection drugs).

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
Mild dose cannabisAlso: marijuana3.53% THC by weight	Drug	Mild dose cannabis
Low dose cannabisAlso: marijuana1.29% THC by weight	Drug	Low dose cannabis
CannabisAlso: placebo marijuana0.00% THC by weight	Drug	Placebo cannabis

Primary outcome

Participants With 30% or Greater Reduction in Pain Intensity
Time frame: baseline to six hours
The primary outcome variable, VAS Pain Intensity, was assessed by asking participants to indicate the intensity of their current pain on a 100-mm visual analog scale (VAS) between 0 (no pain) and 100 (worst possible pain).An assessment was performed before the administration of vaporized cannabis or placebo and hourly thereafter for six hours.

1 secondary outcome

Visual Analogue Scale Pain Intensity Scores for Baseline and up to 5 Hours Following Administration of Vaporized Cannabis
Time frame: baseline to six hours

Results and safety

Results posted to the registry on 9 Apr 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Participants	39	36

Primary outcome: Participants With 30% or Greater Reduction in Pain Intensity

Time frame: baseline to six hours. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Mild Dose Cannabis n = 36	Low Dose Cannabis n = 37	Placebo Cannabis n = 38
Value	61 (45 to 75)	57 (41 to 71)	26 (15 to 42)

Population analysed: This was a cross over study. Ten of the 38 subjects who were exposed to placebo had a 30% reduction in pain intensity as compared to 21 of the 37 exposed to the low dose and 22 of the 36 receiving the medium dose of cannabis.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mild Dose Cannabis	0 of 36 (0%)	0 of 36 (0%)	Not reported
Low Dose Cannabis	0 of 37 (0%)	0 of 37 (0%)	Not reported
Placebo Cannabis	0 of 38 (0%)	0 of 38 (0%)	Not reported

Limitations and caveats (from the sponsor): Inclusion of patients with complex regional pain syndrome type I. In the past, there was no doubt that this disorder should be classified as classical neuropathic pain condition; Unmasking of blinding secondary to the psychoactive effects of cannabis

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 18403272Wilsey B, Marcotte T, Tsodikov A, Millman J, Bentley H, Gouaux B, Fishman S. A randomized, placebo-controlled, crossover trial of cannabis cigarettes in neuropathic pain. J Pain. 2008 Jun;9(6):506-21. doi: 10.1016/j.jpain.2007.12.010. Epub 2008 Apr 10.
Center for Medicinal Cannabis Research websiteLink provided by the sponsor.

Related trials for Neuropathic Pain

RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
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Enrolling by invitationPhase 4
Low Dose Naltrexone Therapy for Complex Regional Pain Syndrome
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RecruitingPhase 2
Effectiveness of Phenotype-based Pain Management Guidelines for Head and Neck Cancer Related Pain: a Pilot Study
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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.

Barth L Wilsey, MD principal investigator

University of California, Davis

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 7 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 31 Jan 2018. 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?

Yes. Results are posted in the registry (first posted 9 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Participants With 30% or Greater Reduction in Pain Intensity (time frame: baseline to six hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01037088, which also lists 1 linked publication.

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 31 Jan 2018.