Trial Outcomes & Findings for Dronabinol Interactions With Cognitive Enhancing Drug in Humans (NCT NCT00842985)
NCT ID: NCT00842985
Last Updated: 2017-05-30
Results Overview
CANTAB RVIP is one component of this computerized battery and is a measure of sustained attention with a working memory component. This study used two subscales of the RVIP. 1. RVP A' ( Target sensitivity, a measure of the ability to detect sequences.) The range is from 0-1; bad to good. 2. RVP B'' ( Response bias, which is a measure of the tendency to respond regardless of whether a target is present. The range is from -1 to +1 ; bad to good The numbers represent probabilities as units on a scale.
COMPLETED
EARLY_PHASE1
53 participants
Once for each test session (4 total).
2017-05-30
Participant Flow
Participant milestones
| Measure |
All Participants
There were 4 sessions given in a counterbalanced order: Dronabinol+Modafinil, Dronabinol+Placebo, Placebo+Modafinil, Placebo+Placebo.
Not all participants received the interventions in the same order.
|
|---|---|
|
Screening
STARTED
|
53
|
|
Screening
COMPLETED
|
26
|
|
Screening
NOT COMPLETED
|
27
|
|
First Intervention
STARTED
|
26
|
|
First Intervention
COMPLETED
|
20
|
|
First Intervention
NOT COMPLETED
|
6
|
|
Washout Period of GE 4 Days
STARTED
|
15
|
|
Washout Period of GE 4 Days
COMPLETED
|
15
|
|
Washout Period of GE 4 Days
NOT COMPLETED
|
0
|
|
Second Intervention
STARTED
|
18
|
|
Second Intervention
COMPLETED
|
17
|
|
Second Intervention
NOT COMPLETED
|
1
|
|
Third Intervention
STARTED
|
15
|
|
Third Intervention
COMPLETED
|
15
|
|
Third Intervention
NOT COMPLETED
|
0
|
|
Fourth Intervention
STARTED
|
15
|
|
Fourth Intervention
COMPLETED
|
15
|
|
Fourth Intervention
NOT COMPLETED
|
0
|
Reasons for withdrawal
| Measure |
All Participants
There were 4 sessions given in a counterbalanced order: Dronabinol+Modafinil, Dronabinol+Placebo, Placebo+Modafinil, Placebo+Placebo.
Not all participants received the interventions in the same order.
|
|---|---|
|
Screening
Did not meet entrance requirements
|
27
|
|
First Intervention
Withdrawal by Subject
|
3
|
|
First Intervention
Protocol Violation
|
3
|
|
Washout Period of GE 4 Days
Withdrawal by Subject
|
2
|
Baseline Characteristics
Dronabinol Interactions With Cognitive Enhancing Drug in Humans
Baseline characteristics by cohort
| Measure |
All Participants
n=53 Participants
There were 4 sessions given in a counterbalanced order: Dronabinol+Modafinil, Dronabinol+Placebo, Placebo+Modafinil, Placebo+Placebo.
Not all participants received the interventions in the same order.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
53 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
|
Age, Continuous
|
33.7 years
STANDARD_DEVIATION 7.7 • n=93 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
42 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
53 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Once for each test session (4 total).Population: Subjects who completed all four treatment sessions. Three of these 15 subjects were not analyzed due to validity concerns of the cognitive data for at least one of the four testing sessions.
CANTAB RVIP is one component of this computerized battery and is a measure of sustained attention with a working memory component. This study used two subscales of the RVIP. 1. RVP A' ( Target sensitivity, a measure of the ability to detect sequences.) The range is from 0-1; bad to good. 2. RVP B'' ( Response bias, which is a measure of the tendency to respond regardless of whether a target is present. The range is from -1 to +1 ; bad to good The numbers represent probabilities as units on a scale.
Outcome measures
| Measure |
THC+Modafinil
n=12 Participants
Session where THC+Modafinil was given.
|
THC+Placebo
n=12 Participants
Session where TCH and Placebo Modafinil were given
|
Pla+Modafinil
n=12 Participants
Session where Placebo THC and Modafinil were given
|
Placebo+Placebo
n=12 Participants
Session where placebo THC and Placebo Modafinil were given.
|
|---|---|---|---|---|
|
CANTAB:CAmbridge Neuropsychological Test Automated Battery RVIP: Rapid Visual Information Processing
|
0.91 units on a scale
Standard Deviation .1
|
0.9 units on a scale
Standard Deviation .1
|
0.92 units on a scale
Standard Deviation .1
|
0.9 units on a scale
Standard Deviation .1
|
Adverse Events
All Participants
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