Trial Outcomes & Findings for Effects of Smoked Marijuana on Risk Taking and Decision Making Tasks (NCT NCT00373399)
NCT ID: NCT00373399
Last Updated: 2018-12-19
Results Overview
A modified version of the Gambling Task (Bechara et al., 1994) was used. Four decks of cards (A-D) were displayed on a computer screen. Volunteers were told that the objective of the game was to win as much money as possible. They were also told that the game entailed a series of card selections from any of the decks, one card at a time, and that they should select cards until instructed to stop. The task was stopped after 100 card selections or after 5 min had elapsed. Data indicate change from baseline in mean number of cards selected from advantageous decks minus number of cards selected from disadvantageous decks as a function of drug condition. Higher numbers indicate better decision making regarding advantageous cards. Planned comparisons using single degrees of freedom, generated by a two-tailed repeated measures analysis of variance (ANOVA), were used to examine the effects of THC concentration (0% vs. 1.8%, 0% vs. 3.9%, and 1.8% vs. 3.9%) on task performance.
COMPLETED
PHASE1
36 participants
3 weeks
2018-12-19
Participant Flow
A total of 36 healthy research volunteers completed this three-session, within-subject outpatient study. Drug treatment was randomized.
Participant milestones
| Measure |
0%, Then 1.98%, Then 3.56% THC
A total of 36 volunteers completed this study. Drug treatment was randomized across 3 sessions so each period corresponds to each possible drug treatment.
|
0%, Then 3.56%, Then 1.98% THC
A total of 36 volunteers completed this study. Drug treatment was randomized across 3 sessions so each period corresponds to each possible drug treatment.
|
1.98%, Then 0%, Then 3.56% THC
A total of 36 volunteers completed this study. Drug treatment was randomized across 3 sessions so each period corresponds to each possible drug treatment.
|
1.98%, Then 3.56%, Then 0% THC
A total of 36 volunteers completed this study. Drug treatment was randomized across 3 sessions so each period corresponds to each possible drug treatment.
|
3.56%, Then 0%, Then 1.98% THC
A total of 36 volunteers completed this study. Drug treatment was randomized across 3 sessions so each period corresponds to each possible drug treatment.
|
3.56%, Then 1.98%, Then 0% THC
A total of 36 volunteers completed this study. Drug treatment was randomized across 3 sessions so each period corresponds to each possible drug treatment.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
7
|
4
|
6
|
7
|
7
|
|
Overall Study
COMPLETED
|
5
|
7
|
4
|
6
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Smoked Marijuana on Risk Taking and Decision Making Tasks
Baseline characteristics by cohort
| Measure |
Total Sample
n=36 Participants
A total of 36 participants completed the study
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
36 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
25.4 years
STANDARD_DEVIATION 4.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
36 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 weeksPopulation: All participants who completed the study (N=36) were included in the final analysis.
A modified version of the Gambling Task (Bechara et al., 1994) was used. Four decks of cards (A-D) were displayed on a computer screen. Volunteers were told that the objective of the game was to win as much money as possible. They were also told that the game entailed a series of card selections from any of the decks, one card at a time, and that they should select cards until instructed to stop. The task was stopped after 100 card selections or after 5 min had elapsed. Data indicate change from baseline in mean number of cards selected from advantageous decks minus number of cards selected from disadvantageous decks as a function of drug condition. Higher numbers indicate better decision making regarding advantageous cards. Planned comparisons using single degrees of freedom, generated by a two-tailed repeated measures analysis of variance (ANOVA), were used to examine the effects of THC concentration (0% vs. 1.8%, 0% vs. 3.9%, and 1.8% vs. 3.9%) on task performance.
Outcome measures
| Measure |
Inactive Marijuana (0%THC)
n=36 Participants
Task performance for all 36 participants under placebo conditions.
|
Low Dose Marijuana (1.8% THC)
n=36 Participants
Task performance for all 36 participants under low dose marijuana conditions.
|
High Dose Marijuana (3.9% THC)
n=36 Participants
Task performance for all 36 participants under high dose marijuana conditions.
|
|---|---|---|---|
|
Change From Baseline in Iowa Gambling Task Scores [Objective Measure of Decision Making]
|
3.7 mean number of cards
Standard Deviation 0.8
|
10.1 mean number of cards
Standard Deviation 3.4
|
4.4 mean number of cards
Standard Deviation 2.1
|
Adverse Events
Inactive Marijuana (0%THC)
Low Dose Marijuana (1.8% THC)
High Dose Marijuana (3.9% THC)
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