Neuropathic PainPhase 1/2NCT00255580
Medicinal Cannabis for Painful HIV Neuropathy
A Phase 1/2 study testing Smoked cannabis in people with Neuropathic Pain, run by Center for Medicinal Cannabis Research at 1 site in United States.
Trial summary
The purpose of this study is to determine if medicinal cannabis (marijuana) is safe and effective for treating pain in individuals with HIV-associated distal, sensory-predominant polyneuropathy (DSPN). Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Neuropathic Pain
- What is being tested?
- Smoked cannabis
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2001to Nov 2006
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented HIV infection
- Meets clinical and electrodiagnostic criteria for HIV-associated DSPN at entry
- Daily pain for at least three consecutive months with an average daily pain magnitude score of at least 5 on the Descriptor Differential Scale
- Inadequate pain relief with prior treatment for painful HIV neuropathy using drugs from at least two different classes of pain-modifying agents (NSAIDS, low-potency opioids, high-potency opioids, sodium channel blockers, other adjunctive pain treatments)
- Age 21-65 years
- Stable use of opioid and non-opioid analgesic medications during the two weeks prior to study entry
Who cannot join
- Positive urine toxicology screen for cannabinoids during the "wash-in" week prior to initiating study treatment
- Recent (i.e. during the month prior to study entry) history of marijuana use more than twice a week
- Previous psychosis with or intolerance to cannabinoids
- A lifetime history (ever) of dependence on cannabis
- Meeting criteria for alcohol or drug dependence within the last 12 months
- Active, major psychiatric disorder likely, in the investigator's opinion, to interfere with adherence to the study protocol
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- Active AIDS-defining opportunistic disease (a history of AIDS-defining opportunistic disease which is no longer active or progressing will not be grounds for exclusion)
- Diabetes mellitus, renal failure with uremia, alcohol abuse, previous spinal surgery, or other documented causes of neuropathy or neuropathic pain
- Pulmonary disease of sufficient severity to require the use of supplemental oxygen
- Asthma
- Life expectancy less than 6 weeks or an active, acute illness likely to interfere with completion of the study protocol
- Pregnancy
- Failure to use adequate birth control in an individual with reproductive potential
- Minority status (less than 21 years), or persons over age 65 years
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
Official title: Placebo-Controlled, Double Blind Trial of Medicinal Cannabis in Painful HIV Neuropathy
The purpose of this study is to determine if medicinal cannabis (marijuana) is safe and effective for treating pain in individuals with HIV-associated distal, sensory-predominant polyneuropathy (DSPN).
Read the detailed description
Peripheral neuropathy occurs in over 30% of patients with HIV infection, making it among the most common neurological complications of HIV infection. Nucleoside analogues such as ddI and d4T, key components of modern, potent, combination antiretroviral therapies (ART), are also neurotoxic and contribute to the frequent occurence of painful neuropathy. By using treatment with available non-narcotic analgesic and adjunctive pain medications, approximately half of patients with painful HIV neuropathy obtain sufficient pain control.
On the first day each study week (active or placebo), participants will follow a specific titration procedure to achieve the optimal dose. This optimal dose will then be continued for the duration of the treatment week. Participants will undergo a 2-week washout period, after which they crossover to the other arm (active or placebo) and will again repeat the dose titration and dose maintenance procedures.
Comparison: Active cannabis doses ranging from 2-8% THC will be compared to placebo for the reduction of neuropathic pain.
- Conditions
- Neuropathic Pain
- Being tested
- Smoked cannabis
- Keywords
- neuropathy, cannabis, marijuana, HIV, DSPN
- Medical subject headings
- Neuralgia, Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoked cannabisDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Active cannabis (1-8% THC by weight) Receives: Drug: Smoked cannabis |
| 2 | Placebo comparator | Placebo cannabis Receives: Drug: Smoked cannabis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptor Differential Scale (DDS)
Measured: Baseline, Post-treatment
Secondary outcomes (4)
Changes in the use of opioid and non-opioid analgesics
Measured: Post-Treatment
Changes in measures of everyday functioning and subject-perceived quality of life
Measured: Baseline, Post-Treatment
Adverse effects
Measured: Post-Treatment
Adverse cognitive effects as assessed by neuropsychological testing.
Measured: Baseline, Post-Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2005 (estimated)
- Study startSep 2001
- Primary completionNov 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for Medicinal Cannabis Research
- Sponsor type
- University, hospital or other
- Investigators
- Ronald Ellis, M.D., Ph.D., Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00255580
- Sponsor's protocol ID
- C00-SD-104
- Status last verified
- Feb 2008
- First submitted
- 17 Nov 2005
- Last updated
- 28 Feb 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo-Controlled, Double Blind Trial of Medicinal Cannabis in Painful HIV Neuropathy
- ClinicalTrials.gov ID
- NCT00255580
- Acronym / sponsor ID
- C00-SD-104
- Conditions
- Neuropathic Pain
- Keywords
- neuropathy, cannabis, marijuana, HIV, DSPN
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Center for Medicinal Cannabis ResearchUniversity, hospital or other
- Study start
- Sep 2001
- Primary completion
- Nov 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 21 Nov 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 if medicinal cannabis (marijuana) is safe and effective for treating pain in individuals with HIV-associated distal, sensory-predominant polyneuropathy (DSPN).
Detailed description
Peripheral neuropathy occurs in over 30% of patients with HIV infection, making it among the most common neurological complications of HIV infection. Nucleoside analogues such as ddI and d4T, key components of modern, potent, combination antiretroviral therapies (ART), are also neurotoxic and contribute to the frequent occurence of painful neuropathy. By using treatment with available non-narcotic analgesic and adjunctive pain medications, approximately half of patients with painful HIV neuropathy obtain sufficient pain control.
On the first day each study week (active or placebo), participants will follow a specific titration procedure to achieve the optimal dose. This optimal dose will then be continued for the duration of the treatment week. Participants will undergo a 2-week washout period, after which they crossover to the other arm (active or placebo) and will again repeat the dose titration and dose maintenance procedures.
Comparison: Active cannabis doses ranging from 2-8% THC will be compared to placebo for the reduction of neuropathic pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Smoked cannabisActive cannabis (1-8% THC by weight) |
| 2 | Placebo comparator | Drug: Smoked cannabisPlacebo cannabis |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Documented HIV infection
- Meets clinical and electrodiagnostic criteria for HIV-associated DSPN at entry
- Daily pain for at least three consecutive months with an average daily pain magnitude score of at least 5 on the Descriptor Differential Scale
- Inadequate pain relief with prior treatment for painful HIV neuropathy using drugs from at least two different classes of pain-modifying agents (NSAIDS, low-potency opioids, high-potency opioids, sodium channel blockers, other adjunctive pain treatments)
- Age 21-65 years
Key exclusion criteria (14 listed)
- Positive urine toxicology screen for cannabinoids during the "wash-in" week prior to initiating study treatment
- Recent (i.e. during the month prior to study entry) history of marijuana use more than twice a week
- Previous psychosis with or intolerance to cannabinoids
- A lifetime history (ever) of dependence on cannabis
- Meeting criteria for alcohol or drug dependence within the last 12 months
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 | 1, 2 |
Primary outcome
Descriptor Differential Scale (DDS)
Time frame: Baseline, Post-treatment
4 secondary outcomes
Changes in the use of opioid and non-opioid analgesics
Time frame: Post-Treatment
Changes in measures of everyday functioning and subject-perceived quality of life
Time frame: Baseline, Post-Treatment
Adverse effects
Time frame: Post-Treatment
Adverse cognitive effects as assessed by neuropsychological testing.
Time frame: Baseline, Post-Treatment
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 28 Feb 2008.
- Center for Medicinal Cannabis ResearchLink provided by the sponsor.
- HIV Neurobehavioral Research CenterLink 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.
Ronald Ellis, M.D., Ph.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 Neuropathic Pain, 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 6 inclusion and 14 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 28 Feb 2008. 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?
Descriptor Differential Scale (DDS) (time frame: Baseline, 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 28 Feb 2008.