Spinal Cord InjuriesPhase 2/3NCT01555983

Vaporized Cannabis and Spinal Cord Injury Pain

A Phase 2/3 study testing Vaporization of Cannabis in people with Spinal Cord Injuries and Spinal Cord Diseases, run by Barth Wilsey 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 will demonstrate that vaporized marijuana results in antinociception when compared to placebo in subjects with spinal cord injury. To further evaluate potential benefits and side effects, the effect of different strengths of cannabis on mood, cognition, and psychomotor performance will also be measured. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Spinal Cord Injuries, Spinal Cord Diseases
What is being tested?: Vaporization of Cannabis
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 42 participants
Where: 1 siteUnited States
Study dates: Jul 2012to Aug 2014
Phase: Phase 2/3
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
Pain intensity ≥ 4/10
Neuropathic pain defined as chronic pain in an area of sensory abnormality corresponding to the spinal cord or nerve root lesion, and the pain should have no primary relation to movement, inflammation or other local tissue damage
Leeds Assessment of Neuropathic Symptoms and Signs score greater than or equal to 12
Spinal cord injury of 3 or more months duration (to avoid spontaneous recovery obfuscating generalizability)

Who cannot join

Known concomitant cerebral damage/cognitive impairment (TBI, Alzheimer's Disease Vascular dementia, Parkinson's disease, dementia with Lewy Bodies and Front temporal dementia
Clinically significant or unstable medical condition (i.e., cardiac, respiratory, hepatic or renal disease) that, in the opinion of the investigator, would compromise participation in the study
Neurologic disorders unrelated to spinal cord injury that may confound the assessment of the central neuropathic pain due to spinal cord injury (hereditary neuropathies; diabetic peripheral neuropathy; traumatic neuropathy; and immune-mediated neuropathies)
Active substance abuse within past year using "The Substance Abuse Module of Diagnostic Interview Schedule for DSM-IV
Pregnancy as ascertained by a self-report and a mandatory commercial pregnancy test
Currently on probation or parole.
Hx of Schizophrenia, Bipolar Depression with Mania, current suicidal ideation or past history of suicide attempt 8. Severe depression (Patient Health Questionnaire-9 ≥ 15) 9. Current suicidal ideation

Trial locations and contacts

1 site in 1 country.

United States1 site

UC Davis CTSC Clinical Research Center , Sacramento VA Medical Center
Mather, California, 95655

Other trials in United States

About this study

Official title: The Effect of Vaporized Cannabis on Neuropathic Pain in Spinal Cord Injury

Read the detailed description

This study will demonstrate that vaporized cannabis can produce antinociceptive effects compared to placebo in human subjects with spinal cord injury (SCI). A within-subject crossover study of the effects of cannabis versus placebo on spontaneous and evoked pain will be performed. A synopsis of antinociception with mood, cognitive impairment, psychomotor performance, and side effects will be obtained to help evaluate the utility of vaporized marijuana in SCI neuropathic pain.

This study will compare the analgesic and side effect profile of low (3.5%) to high dose (7.0%) delta 9-tetrahydrocannabinol in subjects with spinal cord injury pain. It is hypothesized that a low dose will produce a lesser degree of neuropsychological impairment while maintaining a similar degree of pain relief to the higher dose. The use of two different strengths will help determine tolerable dosing for the treatment of SCI neuropathic pain.

Conditions: Spinal Cord Injuries, Spinal Cord Diseases
Being tested: Vaporization of Cannabis
Keywords: cannabis, central neuropathic pain, analgesia
Medical subject headings: Spinal Cord Injuries, Spinal Cord Diseases, Marijuana Abuse, Agnosia

What participants receive

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

Vaporization of CannabisDrug
Also called Medical Marijuana
Randomized, Controlled Crossover Trial of Vaporized Cannabis using different strengths of THC in patients with Central Neuropathic Pain Active Comparator: Vaporized High Dose 6.7% THC Active Comparator: Vaporized High Dose 2.9% THC Placebo Comparator: Vaporized Placebo THC

Study groups in NCT01555983
Study group	Role	What they receive
Vaporization of Cannabis 6.7% THC	Active comparator	Inhaling of standardized measured puffs of Vaporized High Dose 6.7% THC. Monitored for 8 hours measuring psychoactive and analgesic effects. Receives: Drug: Vaporization of Cannabis
Vaporization of Cannabis 2.9% THC	Active comparator	Inhaling standardized measured puffs of Vaporized Low Dose 2.9% THC. Monitored for 8 hours measuring psychoactive and analgesic effects. Receives: Drug: Vaporization of Cannabis
Vaporization of Cannabis Placebo THC	Placebo comparator	Inhaling standardized measured puffs of Placebo THC. Monitored for 8 hours measuring psychoactive and analgesic effects. Receives: Drug: Vaporization of Cannabis

What is being measured

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

Number of Participants Achieving a Reduction in Pain Intensity of 30% or More
Number of participants achieving a reduction of pain intensity of 30% or more, a level believed to be clinically important, was estimated for each treatment dose.
Measured: hourly pain assessments for 8 hours

Timeline

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

Jul 2012Aug 2014

First posted16 Mar 2012 (estimated)
Study startJul 2012
Primary completionAug 2014
Study completionAug 2014

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 (5)Papers the sponsor has linked to this study.
Other trials for Spinal Cord InjuriesStudies 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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 42 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01555983
Sponsor's protocol ID: 256412
Other IDs: 1R01DA030424-01A1
Status last verified: Feb 2017
First submitted: 9 Feb 2012
Last updated: 18 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: email Barth Wilsey at bwilsey@ucsd.edu

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
Abrams DI, Jay CA, Shade SB, Vizoso H, Reda H, Press S, Kelly ME, Rowbotham MC, Petersen KL. Cannabis in painful HIV-associated sensory neuropathy: a randomized placebo-controlled trial. Neurology. 2007 Feb 13;68(7):515-21. doi: 10.1212/01.wnl.0000253187.66183.9c.
PubMed 17296917
Abrams DI, Vizoso HP, Shade SB, Jay C, Kelly ME, Benowitz NL. Vaporization as a smokeless cannabis delivery system: a pilot study. Clin Pharmacol Ther. 2007 Nov;82(5):572-8. doi: 10.1038/sj.clpt.6100200. Epub 2007 Apr 11.
PubMed 17429350
Ellis RJ, Toperoff W, Vaida F, van den Brande G, Gonzales J, Gouaux B, Bentley H, Atkinson JH. Smoked medicinal cannabis for neuropathic pain in HIV: a randomized, crossover clinical trial. Neuropsychopharmacology. 2009 Feb;34(3):672-80. doi: 10.1038/npp.2008.120. Epub 2008 Aug 6.
PubMed 18688212
Wallace M, Schulteis G, Atkinson JH, Wolfson T, Lazzaretto D, Bentley H, Gouaux B, Abramson I. Dose-dependent effects of smoked cannabis on capsaicin-induced pain and hyperalgesia in healthy volunteers. Anesthesiology. 2007 Nov;107(5):785-96. doi: 10.1097/01.anes.0000286986.92475.b7.
PubMed 18073554

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?

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Study at a glance

From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Vaporized Cannabis on Neuropathic Pain in Spinal Cord Injury
ClinicalTrials.gov ID: NCT01555983
Acronym / sponsor ID: 256412
Conditions: Spinal Cord Injuries, Spinal Cord Diseases
Keywords: cannabis, central neuropathic pain, analgesia
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Enrolment: 42 participants (actual)
Lead sponsor: Barth WilseyUniversity, hospital or other
Collaborators: VA Northern California Health Care System, University of California, San Diego, National Institute on Drug Abuse (NIDA)
Study start: Jul 2012
Primary completion: Aug 2014 (actual)
Study completion: Aug 2014 (actual)
First posted: 16 Mar 2012 (estimated)
Results: Posted 15 Jan 2016

Clinical summary

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

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
Vaporization of Cannabis 6.7% THC	Active comparator	Drug: Vaporization of CannabisInhaling of standardized measured puffs of Vaporized High Dose 6.7% THC. Monitored for 8 hours measuring psychoactive and analgesic effects.
Vaporization of Cannabis 2.9% THC	Active comparator	Drug: Vaporization of CannabisInhaling standardized measured puffs of Vaporized Low Dose 2.9% THC. Monitored for 8 hours measuring psychoactive and analgesic effects.
Vaporization of Cannabis Placebo THC	Placebo comparator	Drug: Vaporization of CannabisInhaling standardized measured puffs of Placebo THC. Monitored for 8 hours measuring psychoactive and analgesic effects.

Who may qualify

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

Key inclusion criteria (5 listed)

Age greater than 18 and less than 70
Pain intensity ≥ 4/10
Neuropathic pain defined as chronic pain in an area of sensory abnormality corresponding to the spinal cord or nerve root lesion, and the pain should have no primary relation to movement, inflammation or other local tissue damage
Leeds Assessment of Neuropathic Symptoms and Signs score greater than or equal to 12
Spinal cord injury of 3 or more months duration (to avoid spontaneous recovery obfuscating generalizability)

Key exclusion criteria (7 listed)

Known concomitant cerebral damage/cognitive impairment (TBI, Alzheimer's Disease Vascular dementia, Parkinson's disease, dementia with Lewy Bodies and Front temporal dementia
Clinically significant or unstable medical condition (i.e., cardiac, respiratory, hepatic or renal disease) that, in the opinion of the investigator, would compromise participation in the study
Neurologic disorders unrelated to spinal cord injury that may confound the assessment of the central neuropathic pain due to spinal cord injury (hereditary neuropathies; diabetic peripheral neuropathy; traumatic neuropathy; and immune-mediated neuropathies)
Active substance abuse within past year using "The Substance Abuse Module of Diagnostic Interview Schedule for DSM-IV
Pregnancy as ascertained by a self-report and a mandatory commercial pregnancy test

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
Vaporization of CannabisAlso: Medical MarijuanaRandomized, Controlled Crossover Trial of Vaporized Cannabis using different strengths of THC in patients with Central Neuropathic Pain Active Comparator: Vaporized High Dose 6.7% THC Active Comparator: Vaporized High Dose 2.9% THC Placebo Comparator: Vaporized Placebo THC	Drug	Vaporization of Cannabis 2.9% THC, Vaporization of Cannabis 6.7% THC, Vaporization of Cannabis Placebo THC

Primary outcome

Number of Participants Achieving a Reduction in Pain Intensity of 30% or More
Time frame: hourly pain assessments for 8 hours
Number of participants achieving a reduction of pain intensity of 30% or more, a level believed to be clinically important, was estimated for each treatment dose.

Results and safety

Results posted to the registry on 15 Jan 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo First, Then 2.9%THC, Then 6.7% THC	9	8
Placebo First, Then 6.7%THC, Then 2.9%THC	7	7
2.9%THC First, Then Placebo, Then 6.7%THC	7	7
2.9%THC First, Then 6.7%THC, Then Placebo	7	7
6.7%THC First, Then Placebo, Then 2.9%THC	5	4
6.7%THC First, Then 2.9%THC, Then Placebo	7	6

Primary outcome: Number of Participants Achieving a Reduction in Pain Intensity of 30% or More

Time frame: hourly pain assessments for 8 hours. Number. Unit: participants

Measure	Placebo THC n = 41	2.9% THC n = 38	6.7% THC n = 41
Value	18	26	35

Placebo THC vs 2.9% THC vs 6.7% THC: Cochran-Armitage trend tes: .0001, p <.05, Mixed Models Analysis

Adverse events

Time frame: participants were followed for the 8 hour duration of clinical research center stay. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo THC	0 of 41 (0%)	0 of 41 (0%)	0 of 41
2.9% THC	0 of 38 (0%)	0 of 38 (0%)	0 of 38
6.7% THC	0 of 41 (0%)	1 of 41 (2.4%)	0 of 41

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2017.
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.
Background: PubMed 17296917Abrams DI, Jay CA, Shade SB, Vizoso H, Reda H, Press S, Kelly ME, Rowbotham MC, Petersen KL. Cannabis in painful HIV-associated sensory neuropathy: a randomized placebo-controlled trial. Neurology. 2007 Feb 13;68(7):515-21. doi: 10.1212/01.wnl.0000253187.66183.9c.
Background: PubMed 17429350Abrams DI, Vizoso HP, Shade SB, Jay C, Kelly ME, Benowitz NL. Vaporization as a smokeless cannabis delivery system: a pilot study. Clin Pharmacol Ther. 2007 Nov;82(5):572-8. doi: 10.1038/sj.clpt.6100200. Epub 2007 Apr 11.
Background: PubMed 18688212Ellis RJ, Toperoff W, Vaida F, van den Brande G, Gonzales J, Gouaux B, Bentley H, Atkinson JH. Smoked medicinal cannabis for neuropathic pain in HIV: a randomized, crossover clinical trial. Neuropsychopharmacology. 2009 Feb;34(3):672-80. doi: 10.1038/npp.2008.120. Epub 2008 Aug 6.
Background: PubMed 18073554Wallace M, Schulteis G, Atkinson JH, Wolfson T, Lazzaretto D, Bentley H, Gouaux B, Abramson I. Dose-dependent effects of smoked cannabis on capsaicin-induced pain and hyperalgesia in healthy volunteers. Anesthesiology. 2007 Nov;107(5):785-96. doi: 10.1097/01.anes.0000286986.92475.b7.
Individual participant dataSharing planned: Yes. email Barth Wilsey at bwilsey@ucsd.edu

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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 Wilsey, MD principal investigator

UC San Diego, Department of Psychiatry

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

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Vaporization of Cannabis in people with Spinal Cord Injuries and Spinal Cord Diseases, run by Barth Wilsey 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 5 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 18 Apr 2017. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 15 Jan 2016). 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?

Number of Participants Achieving a Reduction in Pain Intensity of 30% or More (time frame: hourly pain assessments for 8 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 NCT01555983, which also lists 5 linked publications.

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 18 Apr 2017.