PainPhase 1/2NCT00241579
Analgesic Efficacy of Smoked Cannabis
A Phase 1/2 study testing Smoked Cannabis in people with Pain and Hyperalgesia, run by Center for Medicinal Cannabis Research at 1 site in United States.
Trial summary
The purpose of this study is to determine whether or not inhaled marijuana displays any pain-relieving properties on experimentally-induced pain. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Hyperalgesia
- What is being tested?
- Smoked Cannabis
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2002to Jan 2004
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-90
- Male or Female
- Subject smoked cannabis within the last six months
Who cannot join
- Active opportunistic infections or opportunistic malignancies requiring acute treatment
- Active substance abuse (alcohol or injection drug)
- Pulmonary complications (e.g., tuberculosis, asthma)
- Current use of cannabis (e.g., within 30 days of randomization)
- Pregnancy as ascertained by a self-report and a mandatory commercial pregnancy test before any cannabis or placebo consumption condition
- Personal or familial history of psychiatric disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
UC San Diego Medical Center
San Diego, California, 92093
About this study
The purpose of this study is to determine whether or not inhaled marijuana displays any pain-relieving properties on experimentally-induced pain.
Read the detailed description
It is important to evaluate the effects of the cannabinoids on facilitated pain as conditions of hyperalgesia more closely approximates the clinical situation. There are limited clinical studies on the effect of the cannabinoids on facilitated pain states. Noyes et al evaluated the analgesic effects of Delta-9-THC in 34 cancer patients with pain. They concluded that 20mg of oral Delta-9-THC was similar to 120mg of codeine (Noyes et al, 1975). Jain et al concluded that 1.5-3mg of intramuscular Levonantradol resulted in significant pain relief as compared to placebo in 56 patients with acute postoperative pain (Jain et al, 1981).
Comparison(s): Three different doses of smoked cannabis will be compared to placebo for the reduction of experimentally induced pain.
- Conditions
- Pain, Hyperalgesia
- Being tested
- Smoked Cannabis
- Keywords
- Pain, Cannabis, Analgesic
- Medical subject headings
- Pain, Hyperalgesia, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoked CannabisDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Score on a Visual Analog Scale (VAS) of pain severity
McGill Pain Questionnaire (MPQ) Short Form
Neurosensory testing of: 1) warm and cold sensation, 2) warm and cold pain, 3) touch, and 4) mechanical pain. Testing administered using a Thermal Sensory Analyzer, von Frey hair filaments, and a pinch algometer, respectively.
Secondary outcomes (2)
Trail Making Test (TMT) as a measure of psychomotor speed.
Paced Auditory Serial Attention Test (PASAT) as a measure of speed of information processing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2005 (estimated)
- Study startFeb 2002
- Study completionJan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Double blind
- Enrolment
- 15 participants
Sponsor and investigators
- Lead sponsor
- Center for Medicinal Cannabis Research
- Sponsor type
- University, hospital or other
- Investigators
- Mark Wallace, M.D., Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00241579
- Sponsor's protocol ID
- C00-SD-107
- Other IDs
- 021422
- Status last verified
- Jun 2006
- First submitted
- 17 Oct 2005
- Last updated
- 23 Jun 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Smoked Cannabis
- ClinicalTrials.gov ID
- NCT00241579
- Acronym / sponsor ID
- C00-SD-107
- Conditions
- Pain, Hyperalgesia
- Keywords
- Pain, Cannabis, Analgesic
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants
- Lead sponsor
- Center for Medicinal Cannabis ResearchUniversity, hospital or other
- Study start
- Feb 2002
- Study completion
- Jan 2004
- First posted
- 19 Oct 2005 (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 whether or not inhaled marijuana displays any pain-relieving properties on experimentally-induced pain.
Detailed description
It is important to evaluate the effects of the cannabinoids on facilitated pain as conditions of hyperalgesia more closely approximates the clinical situation. There are limited clinical studies on the effect of the cannabinoids on facilitated pain states. Noyes et al evaluated the analgesic effects of Delta-9-THC in 34 cancer patients with pain. They concluded that 20mg of oral Delta-9-THC was similar to 120mg of codeine (Noyes et al, 1975). Jain et al concluded that 1.5-3mg of intramuscular Levonantradol resulted in significant pain relief as compared to placebo in 56 patients with acute postoperative pain (Jain et al, 1981).
Comparison(s): Three different doses of smoked cannabis will be compared to placebo for the reduction of experimentally induced pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-90
- Male or Female
- Subject smoked cannabis within the last six months
Key exclusion criteria (6 listed)
- Active opportunistic infections or opportunistic malignancies requiring acute treatment
- Active substance abuse (alcohol or injection drug)
- Pulmonary complications (e.g., tuberculosis, asthma)
- Current use of cannabis (e.g., within 30 days of randomization)
- Pregnancy as ascertained by a self-report and a mandatory commercial pregnancy test before any cannabis or placebo consumption condition
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 |
|---|---|---|
| Smoked Cannabis | Drug | – |
Primary outcome
Score on a Visual Analog Scale (VAS) of pain severity
McGill Pain Questionnaire (MPQ) Short Form
Neurosensory testing of: 1) warm and cold sensation, 2) warm and cold pain, 3) touch, and 4) mechanical pain. Testing administered using a Thermal Sensory Analyzer, von Frey hair filaments, and a pinch algometer, respectively.
2 secondary outcomes
Trail Making Test (TMT) as a measure of psychomotor speed.
Paced Auditory Serial Attention Test (PASAT) as a measure of speed of information processing.
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 23 Jun 2006.
- Center for Medicinal Cannabis ResearchLink provided by the sponsor.
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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.
Mark 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 Smoked Cannabis in people with Pain and Hyperalgesia, 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 3 inclusion and 6 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 23 Jun 2006. 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. 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?
Score on a Visual Analog Scale (VAS) of pain severity. The study lists 3 primary outcomes in all. 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 23 Jun 2006.