Trial Outcomes & Findings for Effect of Cannabis and Endocannabinoids on HIV Neuropathic Pain (NCT NCT03099005)
NCT ID: NCT03099005
Last Updated: 2024-06-18
Results Overview
This is a scale from 0 to 10 indicating the self-reported level of pain. 0 is the minimum score, indicating no pain. 10 is the maximum score indicating highest level of pain.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
5 participants
Primary outcome timeframe
Pain is measured once before they receive study medication and then 2 minutes after drug treatment.
Results posted on
2024-06-18
Participant Flow
Participant milestones
| Measure |
Cannabis Administration Sessions
Participants attend three daily sessions, separated by 3- to 5-day intervals, where they inhale cannabis products. At one session (Low CBD) they inhale 8 puffs of vaporized cannabis containing 1.9% THC + 0.01 CBD. At one session (Medium CBD) they inhale 8 puffs of vaporized cannabis where 4 puffs contain 1.9% THC + 0.01 CBD and 4 puffs will contain 1.4% THC + 5.1% CBD. At one session (High CBD) they inhale 8 puffs of vaporized cannabis containing 1.4% THC + 5.1% CBD. The order of the Low CBD, Medium CBD, and High CBD sessions is randomized.
Cannabis: vaporization of cannabis
|
|---|---|
|
Overall Study
STARTED
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5
|
|
Overall Study
Low CBD Session
|
5
|
|
Overall Study
Medium CBD Session
|
5
|
|
Overall Study
High CBD Session
|
5
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Cannabis and Endocannabinoids on HIV Neuropathic Pain
Baseline characteristics by cohort
| Measure |
Cannabis Administration Sessions
n=5 Participants
Participants attend three daily sessions, separated by 3- to 5-day intervals, where they inhale cannabis products. At one session (Low CBD) they inhale 8 puffs of vaporized cannabis containing 1.9% THC + 0.01 CBD. At one session (Medium CBD) they inhale 8 puffs of vaporized cannabis where 4 puffs contain 1.9% THC + 0.01 CBD and 4 puffs will contain 1.4% THC + 5.1% CBD. At one session (High CBD) they inhale 8 puffs of vaporized cannabis containing 1.4% THC + 5.1% CBD. The order of the Low CBD, Medium CBD, and High CBD sessions is randomized.
Cannabis: vaporization of cannabis
|
|---|---|
|
Age, Continuous
|
60 years
STANDARD_DEVIATION 3.5 • n=93 Participants
|
|
Sex: Female, Male
Female
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1 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Pain is measured once before they receive study medication and then 2 minutes after drug treatment.This is a scale from 0 to 10 indicating the self-reported level of pain. 0 is the minimum score, indicating no pain. 10 is the maximum score indicating highest level of pain.
Outcome measures
| Measure |
Low CBD Session
n=5 Participants
In the morning, participants will inhale 8 puffs of vaporized cannabis containing 1.9% THC + 0.01% CBD. They will then undergo experimental testing as described below under Outcome Measures.
Cannabis: vaporization of cannabis
|
Medium CBD Session
n=5 Participants
In the morning, participants will inhale 8 puffs of vaporized cannabis 4 puffs will contain 1.9% THC + 0.01% CBD and 4 puffs will contain 1.4% THC + 5.1% CBD. They will then undergo experimental testing as described below under Outcome Measures.
Cannabis: vaporization of cannabis
|
High CBD Session
n=5 Participants
In the morning, participants will inhale 8 puffs of vaporized cannabis containing 1.4% THC + 5.1% CBD. They will then undergo experimental testing as described below under Outcome Measures.
Cannabis: vaporization of cannabis
|
|---|---|---|---|
|
Phase 1 - Numerical Pain Rating Scale (NPRS)
Before Drug Administration
|
2.2 units on a scale
Standard Error 0.7
|
2.6 units on a scale
Standard Error 1
|
2.8 units on a scale
Standard Error 0.8
|
|
Phase 1 - Numerical Pain Rating Scale (NPRS)
After Cannabis Administration
|
1.4 units on a scale
Standard Error 0.6
|
1.2 units on a scale
Standard Error 0.6
|
1.2 units on a scale
Standard Error 0.4
|
SECONDARY outcome
Timeframe: The PGIC was measured two minutes after drug administration.This is a 7-point ordinal scale that asks the participant to rate improvement in their pain after drug administration compared to before drug administration. The scale range is 1 to 7. A score of 1 indicates the greatest improvement (reduction) in pain. A score of 7 indicates that pain is worse.
Outcome measures
| Measure |
Low CBD Session
n=5 Participants
In the morning, participants will inhale 8 puffs of vaporized cannabis containing 1.9% THC + 0.01% CBD. They will then undergo experimental testing as described below under Outcome Measures.
Cannabis: vaporization of cannabis
|
Medium CBD Session
n=5 Participants
In the morning, participants will inhale 8 puffs of vaporized cannabis 4 puffs will contain 1.9% THC + 0.01% CBD and 4 puffs will contain 1.4% THC + 5.1% CBD. They will then undergo experimental testing as described below under Outcome Measures.
Cannabis: vaporization of cannabis
|
High CBD Session
n=5 Participants
In the morning, participants will inhale 8 puffs of vaporized cannabis containing 1.4% THC + 5.1% CBD. They will then undergo experimental testing as described below under Outcome Measures.
Cannabis: vaporization of cannabis
|
|---|---|---|---|
|
Phase 1 - Patient Global Impression of Change (PGIC)
|
2.8 score on a scale
Standard Error 0.6
|
2.6 score on a scale
Standard Error 0.4
|
3.4 score on a scale
Standard Error 0.7
|
SECONDARY outcome
Timeframe: The von Frey test was administered before drug administration and two minutes after drug administration.This test measures sensitivity to pain causes by physical contact with the skin. The von Frey filament is applied to the dorsum of the more painful foot until bending is observed for 3 seconds. Pain is rated using a visual analog score (VAS). The scale is 0 to 100, where 0 indicates no pain and 100 indicates the worst pain.
Outcome measures
| Measure |
Low CBD Session
n=5 Participants
In the morning, participants will inhale 8 puffs of vaporized cannabis containing 1.9% THC + 0.01% CBD. They will then undergo experimental testing as described below under Outcome Measures.
Cannabis: vaporization of cannabis
|
Medium CBD Session
n=5 Participants
In the morning, participants will inhale 8 puffs of vaporized cannabis 4 puffs will contain 1.9% THC + 0.01% CBD and 4 puffs will contain 1.4% THC + 5.1% CBD. They will then undergo experimental testing as described below under Outcome Measures.
Cannabis: vaporization of cannabis
|
High CBD Session
n=5 Participants
In the morning, participants will inhale 8 puffs of vaporized cannabis containing 1.4% THC + 5.1% CBD. They will then undergo experimental testing as described below under Outcome Measures.
Cannabis: vaporization of cannabis
|
|---|---|---|---|
|
Phase 1 - Von Frey Test
Before Drug Administration
|
28 units on a scale
Standard Error 11.1
|
13.4 units on a scale
Standard Error 9.4
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14.5 units on a scale
Standard Error 6.4
|
|
Phase 1 - Von Frey Test
After Cannabis Administration
|
7.4 units on a scale
Standard Error 3.8
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10.8 units on a scale
Standard Error 5.7
|
8.8 units on a scale
Standard Error 5.1
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SECONDARY outcome
Timeframe: The M-scale was administered 2 minutes after drug treatment.The M-scale has 12 true/false statements describing the subjective effects of marijuana on participants after they take the drug. Each question is scored as 0 or 1. The scale ranges from 0 (minimum score) to 12 (maximum score). A lower score indicates that the participant is experiencing fewer side effects of the drug. A higher score indicates that the participant is experiencing more side effects of the drug. Reported side effects on this scale include dry mouth, slower movements, shaking hands, and having a pleasant feeling.
Outcome measures
| Measure |
Low CBD Session
n=5 Participants
In the morning, participants will inhale 8 puffs of vaporized cannabis containing 1.9% THC + 0.01% CBD. They will then undergo experimental testing as described below under Outcome Measures.
Cannabis: vaporization of cannabis
|
Medium CBD Session
n=5 Participants
In the morning, participants will inhale 8 puffs of vaporized cannabis 4 puffs will contain 1.9% THC + 0.01% CBD and 4 puffs will contain 1.4% THC + 5.1% CBD. They will then undergo experimental testing as described below under Outcome Measures.
Cannabis: vaporization of cannabis
|
High CBD Session
n=5 Participants
In the morning, participants will inhale 8 puffs of vaporized cannabis containing 1.4% THC + 5.1% CBD. They will then undergo experimental testing as described below under Outcome Measures.
Cannabis: vaporization of cannabis
|
|---|---|---|---|
|
Phase 1 - Marijuana Subscale (M-scale) of the Addiction Research Center Inventory (ARCI)
|
1.4 score on a scale
Standard Error 0.5
|
3.2 score on a scale
Standard Error 0.6
|
1.8 score on a scale
Standard Error 0.4
|
SECONDARY outcome
Timeframe: AEA was quantified 60 minutes after drug administration.Anandamide levels in plasma were quantified using liquid chromatography-tandem mass spectrometry (LC/MS).
Outcome measures
| Measure |
Low CBD Session
n=5 Participants
In the morning, participants will inhale 8 puffs of vaporized cannabis containing 1.9% THC + 0.01% CBD. They will then undergo experimental testing as described below under Outcome Measures.
Cannabis: vaporization of cannabis
|
Medium CBD Session
n=5 Participants
In the morning, participants will inhale 8 puffs of vaporized cannabis 4 puffs will contain 1.9% THC + 0.01% CBD and 4 puffs will contain 1.4% THC + 5.1% CBD. They will then undergo experimental testing as described below under Outcome Measures.
Cannabis: vaporization of cannabis
|
High CBD Session
n=5 Participants
In the morning, participants will inhale 8 puffs of vaporized cannabis containing 1.4% THC + 5.1% CBD. They will then undergo experimental testing as described below under Outcome Measures.
Cannabis: vaporization of cannabis
|
|---|---|---|---|
|
Phase 1 - Levels of the Endocannabinoid Biomarker Anandamide (AEA)
|
0.52 nanograms per milliliter (ng/ml)
Standard Error 0.08
|
0.53 nanograms per milliliter (ng/ml)
Standard Error 0.16
|
0.49 nanograms per milliliter (ng/ml)
Standard Error 0.13
|
Adverse Events
Low CBD Session
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Medium CBD Session
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
High CBD Session
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Low CBD Session
n=5 participants at risk
In the morning, participants will inhale 8 puffs of vaporized cannabis containing 1.9% THC + 0.01 CBD. They will then undergo experimental testing as described below under Outcome Measures.
Cannabis: vaporization of cannabis
|
Medium CBD Session
n=5 participants at risk
In the morning, participants will inhale 8 puffs of vaporized cannabis 4 puffs will contain 1.9% THC + 0.01 CBD and 4 puffs will contain 1.4% THC + 5.1% CBD. They will then undergo experimental testing as described below under Outcome Measures.
Cannabis: vaporization of cannabis
|
High CBD Session
n=5 participants at risk
In the morning, participants will inhale 8 puffs of vaporized cannabis containing 1.4% THC + 5.1% CBD. They will then undergo experimental testing as described below under Outcome Measures.
Cannabis: vaporization of cannabis
|
|---|---|---|---|
|
General disorders
Drowsiness
|
20.0%
1/5 • Number of events 1 • Adverse event data were collected during the 6 hours following each drug administration.
|
20.0%
1/5 • Number of events 1 • Adverse event data were collected during the 6 hours following each drug administration.
|
20.0%
1/5 • Number of events 1 • Adverse event data were collected during the 6 hours following each drug administration.
|
|
General disorders
Dry Mouth
|
40.0%
2/5 • Number of events 2 • Adverse event data were collected during the 6 hours following each drug administration.
|
40.0%
2/5 • Number of events 2 • Adverse event data were collected during the 6 hours following each drug administration.
|
40.0%
2/5 • Number of events 2 • Adverse event data were collected during the 6 hours following each drug administration.
|
|
General disorders
Cognitive Impairment
|
20.0%
1/5 • Number of events 1 • Adverse event data were collected during the 6 hours following each drug administration.
|
0.00%
0/5 • Adverse event data were collected during the 6 hours following each drug administration.
|
0.00%
0/5 • Adverse event data were collected during the 6 hours following each drug administration.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place