Trial Outcomes & Findings for Role of CBD in Improving Alexithymia (NCT NCT05832281)
NCT ID: NCT05832281
Last Updated: 2026-09-01
Results Overview
Range of scores: 20 to 100 (Higher scores reflect greater challenges or impairment)
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
4 weeks
Results posted on
2026-09-01
Participant Flow
Participants were recruited from a pool of participants who previously participated in studies at the UC San Diego HNRP-CMCR and were willing to be contacted about future studies. The first participant was screened in November 2023.
Adult participants with HIV are randomized to receive Placebo or CBD (a liquid solution of CBD made from semi synthetic CBD powder) for 6 weeks.
Participant milestones
| Measure |
Synthetic CBD 4-Week Trial Arm
For one week they will titrate up to the maintenance dose of 600 mg/day of Purysis, a synthetic, liquid form of CBD, which they will continue for 4 weeks. Upon completion of the 4-week trial, they will be re-assessed, followed by one week of titrating down to discontinuation.
|
Placebo 4-Week Trial Arm
For one week they will titrate up to the maintenance dose of 600 mg/day of placebo for Purysis, a synthetic, liquid form of CBD, which they will continue for 4 weeks. Upon completion of the 4-week trial, they will be re-assessed, followed by one week of titrating down to discontinuation.
|
|---|---|---|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
|
Overall Study
STARTED
|
3
|
3
|
|
Overall Study
COMPLETED
|
2
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Role of CBD in Improving Alexithymia
Baseline characteristics by cohort
| Measure |
Synthetic CBD 4-Week Trial Arm
n=3 Participants
For one week they will titrate up to the maintenance dose of 600 mg/day of Purysis, a synthetic, liquid form of CBD, which they will continue for 4 weeks. Upon completion of the 4-week trial, they will be re-assessed, followed by one week of titrating down to discontinuation.
|
Placebo 4-Week Trial Arm
n=3 Participants
For one week they will titrate up to the maintenance dose of 600 mg/day of placebo for Purysis, a synthetic, liquid form of CBD, which they will continue for 4 weeks. Upon completion of the 4-week trial, they will be re-assessed, followed by one week of titrating down to discontinuation.
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
White
|
2 Participants
n=14 Participants
|
2 Participants
n=36 Participants
|
4 Participants
n=324 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=14 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=324 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=14 Participants
|
2 Participants
n=36 Participants
|
5 Participants
n=324 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
|
Region of Enrollment
United States
|
3 Participants
n=14 Participants
|
3 Participants
n=36 Participants
|
6 Participants
n=324 Participants
|
|
Age, Continuous
|
68.0 Years of age
STANDARD_DEVIATION 2.00 • n=14 Participants
|
76.3 Years of age
STANDARD_DEVIATION 7.37 • n=36 Participants
|
72.2 Years of age
STANDARD_DEVIATION 6.65 • n=324 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=14 Participants
|
1 Participants
n=36 Participants
|
1 Participants
n=324 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=14 Participants
|
2 Participants
n=36 Participants
|
5 Participants
n=324 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=324 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=14 Participants
|
1 Participants
n=36 Participants
|
2 Participants
n=324 Participants
|
|
Education
|
16.0 Years
STANDARD_DEVIATION 3.00 • n=14 Participants
|
16.0 Years
STANDARD_DEVIATION 2.00 • n=36 Participants
|
16.0 Years
STANDARD_DEVIATION 2.28 • n=324 Participants
|
PRIMARY outcome
Timeframe: 4 weeksRange of scores: 20 to 100 (Higher scores reflect greater challenges or impairment)
Outcome measures
| Measure |
Synthetic CBD 4-Week Trial Arm
n=3 Participants
For one week they will titrate up to the maintenance dose of 600 mg/day of Purysis, a synthetic, liquid form of CBD, which they will continue for 4 weeks. Upon completion of the 4-week trial, they will be re-assessed, followed by one week of titrating down to discontinuation.
|
Placebo 4-Week Trial Arm
n=3 Participants
For one week they will titrate up to the maintenance dose of 600 mg/day of placebo for Purysis, a synthetic, liquid form of CBD, which they will continue for 4 weeks. Upon completion of the 4-week trial, they will be re-assessed, followed by one week of titrating down to discontinuation.
|
|---|---|---|
|
Toronto Alexithymia Scale-20 Item Version
|
56.7 Summed points on self-report measure
Standard Deviation 17.1
|
50.7 Summed points on self-report measure
Standard Deviation 12.2
|
Adverse Events
Synthetic CBD 4-Week Trial Arm
Serious events: 0 serious events
Other events: 2 other events
Deaths: 2 deaths
Placebo 4-Week Trial Arm
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Synthetic CBD 4-Week Trial Arm
n=3 participants at risk
For one week they will titrate up to the maintenance dose of 600 mg/day of Purysis, a synthetic, liquid form of CBD, which they will continue for 4 weeks. Upon completion of the 4-week trial, they will be re-assessed, followed by one week of titrating down to discontinuation.
|
Placebo 4-Week Trial Arm
n=3 participants at risk
For one week they will titrate up to the maintenance dose of 600 mg/day of placebo for Purysis, a synthetic, liquid form of CBD, which they will continue for 4 weeks. Upon completion of the 4-week trial, they will be re-assessed, followed by one week of titrating down to discontinuation.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
1/3 • From enrollment until the end of follow-up, up to 5 weeks.
|
0.00%
0/3 • From enrollment until the end of follow-up, up to 5 weeks.
|
|
Gastrointestinal disorders
Dry mouth
|
33.3%
1/3 • From enrollment until the end of follow-up, up to 5 weeks.
|
0.00%
0/3 • From enrollment until the end of follow-up, up to 5 weeks.
|
|
Eye disorders
Eye pain
|
0.00%
0/3 • From enrollment until the end of follow-up, up to 5 weeks.
|
33.3%
1/3 • From enrollment until the end of follow-up, up to 5 weeks.
|
|
General disorders
Fatigue
|
33.3%
1/3 • From enrollment until the end of follow-up, up to 5 weeks.
|
0.00%
0/3 • From enrollment until the end of follow-up, up to 5 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place