- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03099005
Effect of Cannabis and Endocannabinoids on HIV Neuropathic Pain
Effect of Cannabis Administration and Endocannabinoids on HIV Neuropathic Pain Primary Study - Phase 2
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Our objective is to assess 120 community-dwelling people living with HIV who have neuropathic pain and are currently using cannabis. These participants will be enrolled in a study that consists of two phases:
Phase 1) This will involve a cross over study involving three different doses of vaporized cannabis that contain THC and varying concentrations of CBD:
- Low CBD session: 8 puffs of 1.6% THC + 0.09 CBD
- Medium CBD sessions: 4 puffs of 1.6% THC + 0.09 CBD plus 4 puffs of 1.73% THC + 5.4% CBD
- High CBD sessions: 8 puffs of 1.73% THC + 5.4% CBD
This phase will examine the acute effects of cannabis on pain intensity, blood endocannabinoid levels, and the relationship of pain with heart rate variability (HRV).
Phase 2) This phase will involve the association between dispensary-obtained cannabis and changes in pain reported via IMPACT, a mHealth text messaging program that will serve as a useful tool to monitor the relationship between pain and cannabis use. Text messaging is an effective method to modify health behaviors, monitor substance use, and track pain. Our group has recently demonstrated the feasibility of using short message service (SMS) texting to promote anti-retroviral therapy adherence and monitor daily methamphetamine (METH) use in persons living with HIV neuropathy with bipolar disorder or METH dependence.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Brook L Henry, PhD
- Phone Number: (619) 543-4737
- Email: blhenry@ucsd.edu
Study Contact Backup
- Name: Recruitment Office
- Email: hnrprecruitment@ucsd.edu
Study Locations
-
-
California
-
San Diego, California, United States, 92103
- UC Center for Medicinal Cannabis Research, UC San Diego
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- the ability to provide informed consent
- age 18 or older
- HIV infection documented at the HNRP or assessed by an HIV test at screening;
- a diagnosis of HIV sensory neuropathy
- current use of cannabis
- the ability to describe the THC and CBD content in the products they use, i.e., obtaining cannabis from dispensaries that list THC and CBD content
- ability to respond to daily text message
Exclusion Criteria:
- meeting criteria for current substance or alcohol dependence
- traumatic brain injury
- dementia or Alzheimer's disease
- psychosis
- a respiratory condition, i.e., pulmonary disease, that would be exacerbated by inhaling vaporized cannabis
- history of cardiovascular disease, including myocardial infarction or stroke;
- uncontrolled hypertension, defined as a systolic blood pressure greater than 160 mm Hg or a diastolic blood pressure greater than 100 mm Hg
- pregnancy, breastfeeding, or unwillingness to prevent pregnancy during the cannabis administration portion of the study (using birth control in female participants of child- bearing age)
- unwillingness or inability to receive or respond to text messages
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Low CBD session
In the morning, participants will inhale 8 puffs of vaporized cannabis containing 1.6% THC + 0.09 CBD.
They will then undergo experimental testing as described below under Outcome Measures.
|
vaporization of cannabis
Other Names:
|
Active Comparator: Medium CBD session
In the morning, participants will inhale 8 puffs of vaporized cannabis 4 puffs will contain 1.6% THC + 0.09 CBD and 4 puffs will contain 1.73% THC + 5.4% CBD.
They will then undergo experimental testing as described below under Outcome Measures.
|
vaporization of cannabis
Other Names:
|
Active Comparator: High CBD session
In the morning, participants will inhale 8 puffs of vaporized cannabis containing 1.73% THC + 5.4% CBD.
They will then undergo experimental testing as described below under Outcome Measures.
|
vaporization of cannabis
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Phase 1 - numerical 11-point Pain Intensity Scale
Time Frame: participants will be followed for the duration of an 4 hour, single day human laboratory experiment, and the outcome will be measured once before they receive study medication and then 3 additional times during the treatment day
|
an ordinal scale
|
participants will be followed for the duration of an 4 hour, single day human laboratory experiment, and the outcome will be measured once before they receive study medication and then 3 additional times during the treatment day
|
Phase 2 - numerical 11-point Pain Intensity Scale
Time Frame: participants will be queried on a daily basis for six months using text messaging
|
participants receive interactive text questions sent once a day to their cell phone asking them to indicate their average pain level for the day on a 0 to 10 scale
|
participants will be queried on a daily basis for six months using text messaging
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Phase 1 - Patient Global Impression of Change (PGIC)
Time Frame: participants will be followed for the duration of an 4 hour, single day human laboratory experiment, and this outcome will be measured 3 times after study medication is provided during the treatment day
|
a 7 point ordinal scale reflective of improvement in pain
|
participants will be followed for the duration of an 4 hour, single day human laboratory experiment, and this outcome will be measured 3 times after study medication is provided during the treatment day
|
Phase 1 - von Frey test
Time Frame: participants will be followed for the duration of an 4 hour, single day human laboratory experiment, and the outcome will be measured once before they receive study medication and then 3 additional times during the treatment day
|
The von Frey filament will be applied on the dorsum of the more painful foot until bending is observed for 3 seconds, followed by a VAS pain rating
|
participants will be followed for the duration of an 4 hour, single day human laboratory experiment, and the outcome will be measured once before they receive study medication and then 3 additional times during the treatment day
|
Phase 1 - Marijuana subscale (M-scale) of the Addiction Research Center Inventory (ARCI)
Time Frame: participants will be followed for the duration of an 4 hour, single day human laboratory experiment, and the outcome will be measured once before they receive study medication and then 3 additional times during the treatment day
|
The M -scale has 12 true/false statements describing the subjective effects of marijuana
|
participants will be followed for the duration of an 4 hour, single day human laboratory experiment, and the outcome will be measured once before they receive study medication and then 3 additional times during the treatment day
|
Phase 1 - Neuropsychological Assessment Battery
Time Frame: participants will be followed for the duration of an 4 hour, single day human laboratory experiment, and the outcome will be measured once before they receive study medication and then 3 additional times during the treatment day
|
Testing will include the Wechsler Adult Intelligence Scale (WAIS-III) Digit Symbol, Hopkins Verbal Learning Test-Revised and Grooved Pegboard Test (motor)
|
participants will be followed for the duration of an 4 hour, single day human laboratory experiment, and the outcome will be measured once before they receive study medication and then 3 additional times during the treatment day
|
Phase 1 - heart rate variability
Time Frame: participants will be followed for the duration of an 4 hour, single day human laboratory experiment, and the outcome will be measured once before they receive study medication and then 3 additional times during the treatment day
|
Heart Rate Variability (HRV) correlates with the level of pain intensity.
Persons with effective analgesic treatment of chronic pain exhibited improved HRV relative to pain sufferers with ineffective treatment suggesting HRV may serve as a pain biomarker
|
participants will be followed for the duration of an 4 hour, single day human laboratory experiment, and the outcome will be measured once before they receive study medication and then 3 additional times during the treatment day
|
Phase 1 - store plasma samples for evaluation of THC, CBD, and endocannabinoid system biomarkers
Time Frame: participants will be followed for the duration of an 4 hour, single day human laboratory experiment, and the outcome will be measured once before they receive study medication and then 3 additional times during the treatment day
|
Cannabinoid and endocannabinoid levels in plasma will be quantified using a liquid chromatography-tandem mass spectrometry (LC/MS)
|
participants will be followed for the duration of an 4 hour, single day human laboratory experiment, and the outcome will be measured once before they receive study medication and then 3 additional times during the treatment day
|
Collaborators and Investigators
Investigators
- Principal Investigator: Brook L Henry, PhD, University of California, San Diego
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 170510
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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