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Effects of Smoked Marijuana on Risk Taking and Decision Making Tasks

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ClinicalTrials.gov Identifier: NCT00373399
Recruitment Status : Completed
First Posted : September 8, 2006
Results First Posted : October 31, 2018
Last Update Posted : December 19, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Margaret Haney, New York State Psychiatric Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Condition Marijuana Use Disorder
Interventions Drug: Inactive Marijuana (0% THC)
Drug: Low THC marijuana (1.8 %THC)
Drug: High THC marijuana (3.9% THC)
Enrollment 36
Recruitment Details A total of 36 healthy research volunteers completed this three-session, within-subject outpatient study. Drug treatment was randomized.
Pre-assignment Details  
Arm/Group Title 0%, Then 1.98%, Then 3.56% THC 0%, Then 3.56%, Then 1.98% THC 1.98%, Then 0%, Then 3.56% THC 1.98%, Then 3.56%, Then 0% THC 3.56%, Then 0%, Then 1.98% THC 3.56%, Then 1.98%, Then 0% THC
Hide Arm/Group Description A total of 36 volunteers completed this study. Drug treatment was randomized across 3 sessions so each period corresponds to each possible drug treatment. A total of 36 volunteers completed this study. Drug treatment was randomized across 3 sessions so each period corresponds to each possible drug treatment. A total of 36 volunteers completed this study. Drug treatment was randomized across 3 sessions so each period corresponds to each possible drug treatment. A total of 36 volunteers completed this study. Drug treatment was randomized across 3 sessions so each period corresponds to each possible drug treatment. A total of 36 volunteers completed this study. Drug treatment was randomized across 3 sessions so each period corresponds to each possible drug treatment. A total of 36 volunteers completed this study. Drug treatment was randomized across 3 sessions so each period corresponds to each possible drug treatment.
Period Title: Overall Study
Started 5 7 4 6 7 7
Completed 5 7 4 6 7 7
Not Completed 0 0 0 0 0 0
Arm/Group Title Total Sample
Hide Arm/Group Description A total of 36 participants completed the study
Overall Number of Baseline Participants 36
Hide Baseline Analysis Population Description
A total of 36 participants completed the study. Baseline characteristics only available for the 36 completed participants.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
<=18 years
0
   0.0%
Between 18 and 65 years
36
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 36 participants
25.4  (4.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
Female
16
  44.4%
Male
20
  55.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 36 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
13
  36.1%
White
21
  58.3%
More than one race
2
   5.6%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 36 participants
36
 100.0%
1.Primary Outcome
Title Change From Baseline in Iowa Gambling Task Scores [Objective Measure of Decision Making]
Hide Description

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.

Time Frame 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who completed the study (N=36) were included in the final analysis.
Arm/Group Title Inactive Marijuana (0%THC) Low Dose Marijuana (1.8% THC) High Dose Marijuana (3.9% THC)
Hide Arm/Group Description:
Task performance for all 36 participants under placebo conditions.
Task performance for all 36 participants under low dose marijuana conditions.
Task performance for all 36 participants under high dose marijuana conditions.
Overall Number of Participants Analyzed 36 36 36
Mean (Standard Deviation)
Unit of Measure: mean number of cards
3.7  (0.8) 10.1  (3.4) 4.4  (2.1)
Time Frame 3 weeks for each treatment and 1 week after receiving last treatment.
Adverse Event Reporting Description Safety population included all participants who received at least one intervention. Research staff routinely asked participants to report any adverse events occurring during study sessions and during outpatient washout periods.
 
Arm/Group Title Inactive Marijuana (0%THC) Low Dose Marijuana (1.8% THC) High Dose Marijuana (3.9% THC)
Hide Arm/Group Description A total of 36 volunteers completed this study. Drug treatment was randomized across 3 sessions so each period corresponds to each possible drug treatment. Each period contains the number of adverse events reported from each treatment condition. A total of 36 volunteers completed this study. Drug treatment was randomized across 3 sessions so each period corresponds to each possible drug treatment. Each period contains the number of adverse events reported from each treatment condition. A total of 36 volunteers completed this study. Drug treatment was randomized across 3 sessions so each period corresponds to each possible drug treatment. Each period contains the number of adverse events reported from each treatment condition.
All-Cause Mortality
Inactive Marijuana (0%THC) Low Dose Marijuana (1.8% THC) High Dose Marijuana (3.9% THC)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/36 (0.00%)   0/36 (0.00%)   0/36 (0.00%) 
Hide Serious Adverse Events
Inactive Marijuana (0%THC) Low Dose Marijuana (1.8% THC) High Dose Marijuana (3.9% THC)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/36 (0.00%)   0/36 (0.00%)   0/36 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Inactive Marijuana (0%THC) Low Dose Marijuana (1.8% THC) High Dose Marijuana (3.9% THC)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/36 (0.00%)   0/36 (0.00%)   0/36 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Margaret Haney
Organization: New York State Psychiatric Institute
Phone: 646-774-6153
EMail: mh235@cumc.columbia.edu
Layout table for additonal information
Responsible Party: Margaret Haney, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00373399    
Other Study ID Numbers: IRB# 5204
DA-03746 ( Other Grant/Funding Number: National Institute on Drug Abuse )
First Submitted: September 7, 2006
First Posted: September 8, 2006
Results First Submitted: August 7, 2017
Results First Posted: October 31, 2018
Last Update Posted: December 19, 2018