Trial Outcomes & Findings for Acute Effects of Cannabis on Cognition and Mobility in Older HIV-infected and HIV-Un-infected Women (NCT NCT03633721)
NCT ID: NCT03633721
Last Updated: 2025-10-15
Results Overview
Mobility Gait Speed will be tested using the timed gait speed test. Gait speed is measured and reported under normal walking and attention demanding measures. Change in mobility as a function of timed gait speed from before cannabis, or placebo use, to after cannabis, or placebo, use at the 15 minute and 60 minute timepoints will be assessed. The baseline measurement, the mean of the two timepoint measurements, changes from the baselines, and change from the baseline to mean of 15 \& 60 minutes for Cannabis minus that for Placebo, will be reported in meters/second (m/s).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
Baseline, 15 minutes, and 60 minutes after taking cannabis or placebo during first visit. Duration between 1st and 2nd visits up to 7 months apart
Results posted on
2025-10-15
Participant Flow
Participant milestones
| Measure |
HIV Sero Positive: Cannabis 7% delta9-THC Cigarettes First, Then Placebo 0% THC Cigarettes
Drug: Cannabis 7% delta9-THC cigarettes will be smoked by 'light the cigarette' (30 sec), 'get ready' (5 sec), 'inhale' (5 sec), 'hold smoke in lungs' (10 sec) and 'exhale.' Participants will smoke 3 puffs in this manner, with a 40-sec interval between each puff.
Placebo 0% THC cigarettes will be administered to HIV positive women. Participants will be instructed to 'light the cigarette' (30 sec), 'get ready' (5 sec), 'inhale' (5 sec), 'hold smoke in lungs' (10 sec) and 'exhale.' Participants will smoke 3 puffs in this manner, with a 40-sec interval between each puff.
|
HIV Sero Positive: Placebo 0% THC Cigarettes First, Then Cannabis 7% delta9-THC Cigarettes
Placebo 0% THC cigarettes will be administered to HIV positive women. Participants will be instructed to 'light the cigarette' (30 sec), 'get ready' (5 sec), 'inhale' (5 sec), 'hold smoke in lungs' (10 sec) and 'exhale.' Participants will smoke 3 puffs in this manner, with a 40-sec interval between each puff.
Drug: Cannabis 7% delta9-THC cigarettes will be smoked by 'light the cigarette' (30 sec), 'get ready' (5 sec), 'inhale' (5 sec), 'hold smoke in lungs' (10 sec) and 'exhale.' Participants will smoke 3 puffs in this manner, with a 40-sec interval between each puff.
|
HIV Sero Negative: Cannabis 7% delta9-THC Cigarettes First, Then Placebo 0% THC Cigarettes
Drug: Cannabis 7% delta9-THC cigarettes will be smoked by 'light the cigarette' (30 sec), 'get ready' (5 sec), 'inhale' (5 sec), 'hold smoke in lungs' (10 sec) and 'exhale.' Participants will smoke 3 puffs in this manner, with a 40-sec interval between each puff.
Placebo 0% THC cigarettes will be administered to HIV negative women. Participants will be instructed to 'light the cigarette' (30 sec), 'get ready' (5 sec), 'inhale' (5 sec), 'hold smoke in lungs' (10 sec) and 'exhale.' Participants will smoke 3 puffs in this manner, with a 40-sec interval between each puff.
|
HIV Sero Negative: Placebo 0% THC Cigarettes First, Then Cannabis 7% delta9-THC Cigarettes
Placebo 0% THC cigarettes will be administered to HIV negative women. Participants will be instructed to 'light the cigarette' (30 sec), 'get ready' (5 sec), 'inhale' (5 sec), 'hold smoke in lungs' (10 sec) and 'exhale.' Participants will smoke 3 puffs in this manner, with a 40-sec interval between each puff.
Drug: Cannabis 7% delta9-THC cigarettes will be smoked by 'light the cigarette' (30 sec), 'get ready' (5 sec), 'inhale' (5 sec), 'hold smoke in lungs' (10 sec) and 'exhale.' Participants will smoke 3 puffs in this manner, with a 40-sec interval between each puff.
|
|---|---|---|---|---|
|
First Intervention (< 1 Day)
STARTED
|
10
|
4
|
5
|
6
|
|
First Intervention (< 1 Day)
COMPLETED
|
10
|
4
|
5
|
6
|
|
First Intervention (< 1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Washout (From 1 Day to 212 Days)
STARTED
|
10
|
4
|
5
|
6
|
|
Washout (From 1 Day to 212 Days)
COMPLETED
|
8
|
3
|
5
|
5
|
|
Washout (From 1 Day to 212 Days)
NOT COMPLETED
|
2
|
1
|
0
|
1
|
|
Second Intervention (< 1 Day)
STARTED
|
8
|
3
|
5
|
5
|
|
Second Intervention (< 1 Day)
COMPLETED
|
8
|
3
|
5
|
5
|
|
Second Intervention (< 1 Day)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
HIV Sero Positive: Cannabis 7% delta9-THC Cigarettes First, Then Placebo 0% THC Cigarettes
Drug: Cannabis 7% delta9-THC cigarettes will be smoked by 'light the cigarette' (30 sec), 'get ready' (5 sec), 'inhale' (5 sec), 'hold smoke in lungs' (10 sec) and 'exhale.' Participants will smoke 3 puffs in this manner, with a 40-sec interval between each puff.
Placebo 0% THC cigarettes will be administered to HIV positive women. Participants will be instructed to 'light the cigarette' (30 sec), 'get ready' (5 sec), 'inhale' (5 sec), 'hold smoke in lungs' (10 sec) and 'exhale.' Participants will smoke 3 puffs in this manner, with a 40-sec interval between each puff.
|
HIV Sero Positive: Placebo 0% THC Cigarettes First, Then Cannabis 7% delta9-THC Cigarettes
Placebo 0% THC cigarettes will be administered to HIV positive women. Participants will be instructed to 'light the cigarette' (30 sec), 'get ready' (5 sec), 'inhale' (5 sec), 'hold smoke in lungs' (10 sec) and 'exhale.' Participants will smoke 3 puffs in this manner, with a 40-sec interval between each puff.
Drug: Cannabis 7% delta9-THC cigarettes will be smoked by 'light the cigarette' (30 sec), 'get ready' (5 sec), 'inhale' (5 sec), 'hold smoke in lungs' (10 sec) and 'exhale.' Participants will smoke 3 puffs in this manner, with a 40-sec interval between each puff.
|
HIV Sero Negative: Cannabis 7% delta9-THC Cigarettes First, Then Placebo 0% THC Cigarettes
Drug: Cannabis 7% delta9-THC cigarettes will be smoked by 'light the cigarette' (30 sec), 'get ready' (5 sec), 'inhale' (5 sec), 'hold smoke in lungs' (10 sec) and 'exhale.' Participants will smoke 3 puffs in this manner, with a 40-sec interval between each puff.
Placebo 0% THC cigarettes will be administered to HIV negative women. Participants will be instructed to 'light the cigarette' (30 sec), 'get ready' (5 sec), 'inhale' (5 sec), 'hold smoke in lungs' (10 sec) and 'exhale.' Participants will smoke 3 puffs in this manner, with a 40-sec interval between each puff.
|
HIV Sero Negative: Placebo 0% THC Cigarettes First, Then Cannabis 7% delta9-THC Cigarettes
Placebo 0% THC cigarettes will be administered to HIV negative women. Participants will be instructed to 'light the cigarette' (30 sec), 'get ready' (5 sec), 'inhale' (5 sec), 'hold smoke in lungs' (10 sec) and 'exhale.' Participants will smoke 3 puffs in this manner, with a 40-sec interval between each puff.
Drug: Cannabis 7% delta9-THC cigarettes will be smoked by 'light the cigarette' (30 sec), 'get ready' (5 sec), 'inhale' (5 sec), 'hold smoke in lungs' (10 sec) and 'exhale.' Participants will smoke 3 puffs in this manner, with a 40-sec interval between each puff.
|
|---|---|---|---|---|
|
Washout (From 1 Day to 212 Days)
Withdrawal by Subject
|
2
|
1
|
0
|
1
|
Baseline Characteristics
Acute Effects of Cannabis on Cognition and Mobility in Older HIV-infected and HIV-Un-infected Women
Baseline characteristics by cohort
| Measure |
HIV Sero Positive: Cannabis 7% delta9-THC Cigarettes First, Then Placebo 0% THC Cigarettes
n=10 Participants
Drug: Cannabis 7% delta9-THC cigarettes will be smoked by 'light the cigarette' (30 sec), 'get ready' (5 sec), 'inhale' (5 sec), 'hold smoke in lungs' (10 sec) and 'exhale.' Participants will smoke 3 puffs in this manner, with a 40-sec interval between each puff.
Placebo 0% THC cigarettes will be administered to HIV positive women. Participants will be instructed to 'light the cigarette' (30 sec), 'get ready' (5 sec), 'inhale' (5 sec), 'hold smoke in lungs' (10 sec) and 'exhale.' Participants will smoke 3 puffs in this manner, with a 40-sec interval between each puff.
|
HIV Sero Positive: Placebo 0% THC Cigarettes First, Then Cannabis 7% delta9-THC Cigarettes
n=4 Participants
Placebo 0% THC cigarettes will be administered to HIV positive women. Participants will be instructed to 'light the cigarette' (30 sec), 'get ready' (5 sec), 'inhale' (5 sec), 'hold smoke in lungs' (10 sec) and 'exhale.' Participants will smoke 3 puffs in this manner, with a 40-sec interval between each puff.
Drug: Cannabis 7% delta9-THC cigarettes will be smoked by 'light the cigarette' (30 sec), 'get ready' (5 sec), 'inhale' (5 sec), 'hold smoke in lungs' (10 sec) and 'exhale.' Participants will smoke 3 puffs in this manner, with a 40-sec interval between each puff.
|
HIV Sero Negative: Cannabis 7% delta9-THC Cigarettes First, Then Placebo 0% THC Cigarettes
n=5 Participants
Drug: Cannabis 7% delta9-THC cigarettes will be smoked by 'light the cigarette' (30 sec), 'get ready' (5 sec), 'inhale' (5 sec), 'hold smoke in lungs' (10 sec) and 'exhale.' Participants will smoke 3 puffs in this manner, with a 40-sec interval between each puff.
Placebo 0% THC cigarettes will be administered to HIV negative women. Participants will be instructed to 'light the cigarette' (30 sec), 'get ready' (5 sec), 'inhale' (5 sec), 'hold smoke in lungs' (10 sec) and 'exhale.' Participants will smoke 3 puffs in this manner, with a 40-sec interval between each puff.
|
HIV Sero Negative: Placebo 0% THC Cigarettes First, Then Cannabis 7% delta9-THC Cigarettes
n=6 Participants
Placebo 0% THC cigarettes will be administered to HIV negative women. Participants will be instructed to 'light the cigarette' (30 sec), 'get ready' (5 sec), 'inhale' (5 sec), 'hold smoke in lungs' (10 sec) and 'exhale.' Participants will smoke 3 puffs in this manner, with a 40-sec interval between each puff.
Drug: Cannabis 7% delta9-THC cigarettes will be smoked by 'light the cigarette' (30 sec), 'get ready' (5 sec), 'inhale' (5 sec), 'hold smoke in lungs' (10 sec) and 'exhale.' Participants will smoke 3 puffs in this manner, with a 40-sec interval between each puff.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
48.0 years
n=5 Participants
|
56.5 years
n=7 Participants
|
50.0 years
n=5 Participants
|
45.5 years
n=4 Participants
|
50 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Non Black
|
3 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
5 participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black
|
7 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
5 participants
n=4 Participants
|
20 participants
n=21 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5 participants
n=5 Participants
|
6 participants
n=4 Participants
|
25 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, 15 minutes, and 60 minutes after taking cannabis or placebo during first visit. Duration between 1st and 2nd visits up to 7 months apartMobility Gait Speed will be tested using the timed gait speed test. Gait speed is measured and reported under normal walking and attention demanding measures. Change in mobility as a function of timed gait speed from before cannabis, or placebo use, to after cannabis, or placebo, use at the 15 minute and 60 minute timepoints will be assessed. The baseline measurement, the mean of the two timepoint measurements, changes from the baselines, and change from the baseline to mean of 15 \& 60 minutes for Cannabis minus that for Placebo, will be reported in meters/second (m/s).
Outcome measures
| Measure |
HIV Sero Positive: Cannabis 7% delta9-THC Cigarettes First, Then Placebo 0% THC Cigarettes
n=8 Participants
Drug: Cannabis 7% delta9-THC cigarettes will be smoked by 'light the cigarette' (30 sec), 'get ready' (5 sec), 'inhale' (5 sec), 'hold smoke in lungs' (10 sec) and 'exhale.' Participants will smoke 3 puffs in this manner, with a 40-sec interval between each puff.
|
HIV Sero Positive: Placebo 0% THC Cigarettes First, Then Cannabis 7% delta9-THC Cigarettes
n=3 Participants
Placebo 0% THC cigarettes will be administered to HIV positive women. Participants will be instructed to 'light the cigarette' (30 sec), 'get ready' (5 sec), 'inhale' (5 sec), 'hold smoke in lungs' (10 sec) and 'exhale.' Participants will smoke 3 puffs in this manner, with a 40-sec interval between each puff.
|
HIV Sero Negative: Cannabis 7% delta9-THC Cigarettes First, Then Placebo 0% THC Cigarettes
n=5 Participants
Drug: Cannabis 7% delta9-THC cigarettes will be smoked by 'light the cigarette' (30 sec), 'get ready' (5 sec), 'inhale' (5 sec), 'hold smoke in lungs' (10 sec) and 'exhale.' Participants will smoke 3 puffs in this manner, with a 40-sec interval between each puff.
|
HIV Sero Negative: Placebo 0% THC Cigarettes First, Then Cannabis 7% delta9-THC Cigarettes
n=5 Participants
Placebo 0% THC cigarettes will be administered to HIV negative women. Participants will be instructed to 'light the cigarette' (30 sec), 'get ready' (5 sec), 'inhale' (5 sec), 'hold smoke in lungs' (10 sec) and 'exhale.' Participants will smoke 3 puffs in this manner, with a 40-sec interval between each puff.
|
|---|---|---|---|---|
|
Change in Acute Effects of Cannabis on Mobility Gait Speed (m/s)
Baseline using Placebo
|
2.89 m/s
Standard Error 0.16
|
3.11 m/s
Standard Error 0.54
|
2.87 m/s
Standard Error 0.26
|
2.99 m/s
Standard Error 0.32
|
|
Change in Acute Effects of Cannabis on Mobility Gait Speed (m/s)
Mean of 15 minute and 60 minute timepoint using Placebo
|
2.86 m/s
Standard Error 0.15
|
3.16 m/s
Standard Error 0.53
|
3.04 m/s
Standard Error 0.23
|
2.92 m/s
Standard Error 0.20
|
|
Change in Acute Effects of Cannabis on Mobility Gait Speed (m/s)
Change from Baseline using Placebo
|
-0.03 m/s
Standard Error 0.09
|
0.05 m/s
Standard Error 0.19
|
0.16 m/s
Standard Error 0.05
|
-0.07 m/s
Standard Error 0.14
|
|
Change in Acute Effects of Cannabis on Mobility Gait Speed (m/s)
Baseline using Cannabis
|
2.80 m/s
Standard Error 0.17
|
3.34 m/s
Standard Error 0.70
|
2.59 m/s
Standard Error 0.33
|
3.05 m/s
Standard Error 0.31
|
|
Change in Acute Effects of Cannabis on Mobility Gait Speed (m/s)
Mean of 15 minute and 60 minute timepoint using Cannabis
|
2.82 m/s
Standard Error 0.12
|
3.03 m/s
Standard Error 0.59
|
2.80 m/s
Standard Error 0.34
|
3.14 m/s
Standard Error 0.18
|
|
Change in Acute Effects of Cannabis on Mobility Gait Speed (m/s)
Change from Baseline using Cannabis
|
0.02 m/s
Standard Error 0.14
|
-0.31 m/s
Standard Error 0.25
|
0.21 m/s
Standard Error 0.05
|
0.08 m/s
Standard Error 0.20
|
|
Change in Acute Effects of Cannabis on Mobility Gait Speed (m/s)
Change from Baseline to Mean of 15 & 60 minutes for Cannabis minus that for Placebo
|
0.05 m/s
Standard Error 0.11
|
-0.35 m/s
Standard Error 0.45
|
0.04 m/s
Standard Error 0.05
|
0.15 m/s
Standard Error 0.14
|
PRIMARY outcome
Timeframe: Baseline, 15 minutes, and 60 minutes after taking cannabis or placebo during first visit. Duration between 1st and 2nd visits up to 7 months apartChange in balance from baseline will be tested using the Functional Reach test. Functional reach measures the distance the subject can reach in front of them from a standing position without losing balance. Change in balance from before cannabis, or placebo, use to after cannabis, or placebo, use at the 15 minute and 60 minute timepoints will be assessed. The baseline measurement, the mean of the two timepoint measurements, changes from the baselines, and change from the baseline to mean of 15 \& 60 minutes for Cannabis minus that for Placebo, will be reported in centimeters (cm).
Outcome measures
| Measure |
HIV Sero Positive: Cannabis 7% delta9-THC Cigarettes First, Then Placebo 0% THC Cigarettes
n=8 Participants
Drug: Cannabis 7% delta9-THC cigarettes will be smoked by 'light the cigarette' (30 sec), 'get ready' (5 sec), 'inhale' (5 sec), 'hold smoke in lungs' (10 sec) and 'exhale.' Participants will smoke 3 puffs in this manner, with a 40-sec interval between each puff.
|
HIV Sero Positive: Placebo 0% THC Cigarettes First, Then Cannabis 7% delta9-THC Cigarettes
n=3 Participants
Placebo 0% THC cigarettes will be administered to HIV positive women. Participants will be instructed to 'light the cigarette' (30 sec), 'get ready' (5 sec), 'inhale' (5 sec), 'hold smoke in lungs' (10 sec) and 'exhale.' Participants will smoke 3 puffs in this manner, with a 40-sec interval between each puff.
|
HIV Sero Negative: Cannabis 7% delta9-THC Cigarettes First, Then Placebo 0% THC Cigarettes
n=5 Participants
Drug: Cannabis 7% delta9-THC cigarettes will be smoked by 'light the cigarette' (30 sec), 'get ready' (5 sec), 'inhale' (5 sec), 'hold smoke in lungs' (10 sec) and 'exhale.' Participants will smoke 3 puffs in this manner, with a 40-sec interval between each puff.
|
HIV Sero Negative: Placebo 0% THC Cigarettes First, Then Cannabis 7% delta9-THC Cigarettes
n=5 Participants
Placebo 0% THC cigarettes will be administered to HIV negative women. Participants will be instructed to 'light the cigarette' (30 sec), 'get ready' (5 sec), 'inhale' (5 sec), 'hold smoke in lungs' (10 sec) and 'exhale.' Participants will smoke 3 puffs in this manner, with a 40-sec interval between each puff.
|
|---|---|---|---|---|
|
Change in Acute Effects of Cannabis on Balance - Functional Reach (cm)
Baseline using Placebo
|
28.22 cm
Standard Error 2.58
|
18.77 cm
Standard Error 3.36
|
36.75 cm
Standard Error 5.15
|
29.72 cm
Standard Error 3.74
|
|
Change in Acute Effects of Cannabis on Balance - Functional Reach (cm)
Mean of 15 minute and 60 minute timepoint using Placebo
|
26.92 cm
Standard Error 3.32
|
26.40 cm
Standard Error 5.72
|
32.13 cm
Standard Error 5.93
|
28.21 cm
Standard Error 3.95
|
|
Change in Acute Effects of Cannabis on Balance - Functional Reach (cm)
Change from Baseline using Placebo
|
-1.30 cm
Standard Error 1.66
|
3.64 cm
Standard Error 2.84
|
-4.61 cm
Standard Error 1.63
|
-1.51 cm
Standard Error 0.79
|
|
Change in Acute Effects of Cannabis on Balance - Functional Reach (cm)
Baseline using Cannabis
|
28.71 cm
Standard Error 3.71
|
22.39 cm
Standard Error 4.59
|
31.34 cm
Standard Error 3.82
|
34.26 cm
Standard Error 6.06
|
|
Change in Acute Effects of Cannabis on Balance - Functional Reach (cm)
Mean of 15 minute and 60 minute timepoint using Cannabis
|
29.65 cm
Standard Error 4.00
|
18.04 cm
Standard Error 3.09
|
33.87 cm
Standard Error 4.51
|
30.93 cm
Standard Error 2.37
|
|
Change in Acute Effects of Cannabis on Balance - Functional Reach (cm)
Change from Baseline using Cannabis
|
0.94 cm
Standard Error 3.71
|
-4.35 cm
Standard Error 2.36
|
2.52 cm
Standard Error 1.60
|
-3.33 cm
Standard Error 3.98
|
|
Change in Acute Effects of Cannabis on Balance - Functional Reach (cm)
Change from Baseline to Mean of 15 & 60 minutes for Cannabis minus that for Placebo
|
2.24 cm
Standard Error 3.41
|
-7.99 cm
Standard Error 3.79
|
7.14 cm
Standard Error 2.01
|
-1.82 cm
Standard Error 4.64
|
PRIMARY outcome
Timeframe: Baseline, 15 minutes, and 60 minutes after taking cannabis or placebo during first visit. Duration between 1st and 2nd visits up to 7 months apartCognition will be tested using the number of correct suppressions on the Sustained Attention to Response Task (SART). Participants were asked to respond to a series of digits on a computer screen by pressing a key as quickly as possible for every digit except "3". The percentage of correct suppressions is quantified. Change in the percentage of mean correct suppressions before cannabis (or placebo) use to after cannabis (or placebo) at the 15 minute and 60 minute timepoints will be assessed. The baseline measurement, the mean percentage of the two timepoint measurements, the mean percentage changes from baseline values, and change from the baseline to mean of 15 \& 60 minutes for Cannabis minus that for Placebo, will be reported.
Outcome measures
| Measure |
HIV Sero Positive: Cannabis 7% delta9-THC Cigarettes First, Then Placebo 0% THC Cigarettes
n=8 Participants
Drug: Cannabis 7% delta9-THC cigarettes will be smoked by 'light the cigarette' (30 sec), 'get ready' (5 sec), 'inhale' (5 sec), 'hold smoke in lungs' (10 sec) and 'exhale.' Participants will smoke 3 puffs in this manner, with a 40-sec interval between each puff.
|
HIV Sero Positive: Placebo 0% THC Cigarettes First, Then Cannabis 7% delta9-THC Cigarettes
n=3 Participants
Placebo 0% THC cigarettes will be administered to HIV positive women. Participants will be instructed to 'light the cigarette' (30 sec), 'get ready' (5 sec), 'inhale' (5 sec), 'hold smoke in lungs' (10 sec) and 'exhale.' Participants will smoke 3 puffs in this manner, with a 40-sec interval between each puff.
|
HIV Sero Negative: Cannabis 7% delta9-THC Cigarettes First, Then Placebo 0% THC Cigarettes
n=5 Participants
Drug: Cannabis 7% delta9-THC cigarettes will be smoked by 'light the cigarette' (30 sec), 'get ready' (5 sec), 'inhale' (5 sec), 'hold smoke in lungs' (10 sec) and 'exhale.' Participants will smoke 3 puffs in this manner, with a 40-sec interval between each puff.
|
HIV Sero Negative: Placebo 0% THC Cigarettes First, Then Cannabis 7% delta9-THC Cigarettes
n=5 Participants
Placebo 0% THC cigarettes will be administered to HIV negative women. Participants will be instructed to 'light the cigarette' (30 sec), 'get ready' (5 sec), 'inhale' (5 sec), 'hold smoke in lungs' (10 sec) and 'exhale.' Participants will smoke 3 puffs in this manner, with a 40-sec interval between each puff.
|
|---|---|---|---|---|
|
Change in Acute Effects of Cannabis on Cognition Using Sustained Attention Response Test (% Correct Suppressions)
Baseline using Placebo
|
84.00 Percentage of correct suppressions
Standard Error 1.51
|
64.00 Percentage of correct suppressions
Standard Error 16.17
|
87.40 Percentage of correct suppressions
Standard Error 3.71
|
79.20 Percentage of correct suppressions
Standard Error 9.75
|
|
Change in Acute Effects of Cannabis on Cognition Using Sustained Attention Response Test (% Correct Suppressions)
Mean of 15 minute and 60 minute timepoint using Placebo
|
82.25 Percentage of correct suppressions
Standard Error 2.25
|
78.67 Percentage of correct suppressions
Standard Error 6.77
|
74.00 Percentage of correct suppressions
Standard Error 10.62
|
78.40 Percentage of correct suppressions
Standard Error 10.05
|
|
Change in Acute Effects of Cannabis on Cognition Using Sustained Attention Response Test (% Correct Suppressions)
Change from Baseline using Placebo
|
-1.75 Percentage of correct suppressions
Standard Error 2.25
|
14.67 Percentage of correct suppressions
Standard Error 10.09
|
-12.40 Percentage of correct suppressions
Standard Error 8.01
|
-0.80 Percentage of correct suppressions
Standard Error 7.58
|
|
Change in Acute Effects of Cannabis on Cognition Using Sustained Attention Response Test (% Correct Suppressions)
Baseline using Cannabis
|
80.50 Percentage of correct suppressions
Standard Error 5.58
|
85.33 Percentage of correct suppressions
Standard Error 2.67
|
90.40 Percentage of correct suppressions
Standard Error 4.49
|
80.00 Percentage of correct suppressions
Standard Error 12.77
|
|
Change in Acute Effects of Cannabis on Cognition Using Sustained Attention Response Test (% Correct Suppressions)
Mean of 15 minute and 60 minute timepoint using Cannabis
|
85.50 Percentage of correct suppressions
Standard Error 2.80
|
88.67 Percentage of correct suppressions
Standard Error 3.53
|
80.00 Percentage of correct suppressions
Standard Error 7.80
|
78.00 Percentage of correct suppressions
Standard Error 13.90
|
|
Change in Acute Effects of Cannabis on Cognition Using Sustained Attention Response Test (% Correct Suppressions)
Change from Baseline using Cannabis
|
5.00 Percentage of correct suppressions
Standard Error 3.96
|
3.33 Percentage of correct suppressions
Standard Error 1.33
|
-10.00 Percentage of correct suppressions
Standard Error 8.01
|
-2.00 Percentage of correct suppressions
Standard Error 1.67
|
|
Change in Acute Effects of Cannabis on Cognition Using Sustained Attention Response Test (% Correct Suppressions)
Change from Baseline to Mean of 15 & 60 minutes for Cannabis minus that for Placebo
|
6.75 Percentage of correct suppressions
Standard Error 5.14
|
-11.33 Percentage of correct suppressions
Standard Error 11.10
|
2.00 Percentage of correct suppressions
Standard Error 5.10
|
-1.20 Percentage of correct suppressions
Standard Error 9.02
|
Adverse Events
HIV Sero Positive: Cannabis 7% delta9-THC Cigarettes
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
HIV Sero Positive: Placebo 0% THC Cigarettes
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
HIV Sero Negative: Cannabis 7% delta9-THC Cigarettes
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
HIV Sero Negative: Placebo 0% THC Cigarettes
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place