Effects of Smoked Marijuana on Risk Taking and Decision Making Tasks

• 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: New York State Psychiatric Institute
• 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

Participant Flow

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
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

Baseline Characteristics

Arm/Group Title		Total Sample
Arm/Group Description		A total of 36 participants completed the study
Overall Number of Baseline Participants		36
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%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Iowa Gambling Task Scores [Objective Measure of Decision Making]
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

Outcome Measure Data

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)
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)

Adverse Events

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)
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%)
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%)
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%)

Limitations and Caveats

[Not Specified]

More Information

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

• Name/Title: Margaret Haney
• Organization: New York State Psychiatric Institute
• Phone: 646-774-6153
• EMail: mh235@cumc.columbia.edu

• 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