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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

Tracking Information
First Submitted Date  ICMJE September 7, 2006
First Posted Date  ICMJE September 8, 2006
Results First Submitted Date  ICMJE August 7, 2017
Results First Posted Date  ICMJE October 31, 2018
Last Update Posted Date December 19, 2018
Study Start Date  ICMJE May 2006
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 4, 2018)
Change From Baseline in Iowa Gambling Task Scores [Objective Measure of Decision Making] [ Time Frame: 3 weeks ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 7, 2006)
After smoking marijuana participants will demonstrate poorer decision-making abilities and increased risk-taking behaviors.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Smoked Marijuana on Risk Taking and Decision Making Tasks
Official Title  ICMJE Acute Effects of Smoked Marijuana on Decision Making, as Assessed by a Modified Gambling Task, in Experienced Marijuana Users
Brief Summary The purpose of this study is to investigate the effects of smoked marijuana on both risk taking and decision making tasks.
Detailed Description Cannabis abuse and dependence are the most prevalent drug use disorders in the United States (Compton et al., 2004), yet little is known about the factors contributing to successful marijuana treatment. Previously, we have shown that cognitive impairments in patients treated for substance disorders are associated with premature treatment dropout. However, little is known about whether such impairments are the result of drug use per se. The objective of this within-subject study is to determine whether decision-making and risk-taking are affected by acute cannabis intoxication. The Balloon Analogue Risk Task (BART; Lejuez et al. 2002) assesses decision making in a context of increasing risk, and the Iowa Gambling Task (IGT; Bechara et al. 1994) tests the ability to balance immediate rewards against long-term negative consequences; both tasks have strong face validity for evaluating cognitive deficits that may contribute to poor treatment outcome. Research volunteers will be current marijuana smokers. Each will participate in three, 4-hour outpatient sessions in the Substance Use Research Center (SURC) in the Division of Substance Abuse at NYSPI. They will smoke a different strength marijuana cigarette (0.0, 1.98, 3.9% THC) in each session in counter-balanced order. After baseline data have been collected (risk taking and decision making behaviors, heart rate, blood pressure, mood scales, exhaled carbon monoxide), participants will take 3-6 puffs, 5 seconds in duration, from a National Institute on Drug Abuse (NIDA) marijuana cigarette. After smoking, we will repeatedly re-assess risk taking and decision making abilities with the BART and IGT. We will also measure subjective mood ratings, heart rate and blood pressure repeatedly for 180 minutes following smoking. This study is the first controlled investigation of the effects of smoked marijuana on both risk taking and decision making tasks. The data obtained will be used to guide treatment development for marijuana use disorders.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Masking Description:
Double-blind, placebo-controlled
Primary Purpose: Basic Science
Condition  ICMJE Marijuana Use Disorder
Intervention  ICMJE
  • Drug: Inactive Marijuana (0% THC)
    Placebo marijuana was administered using a cued-smoking procedure, which produces reliable increases in heart-rate and plasma THC. All marijuana cigarettes were administered in a double-blind fashion.
    Other Name: placebo marijuana
  • Drug: Low THC marijuana (1.8 %THC)
    Active marijuana (1.8 % THC) was administered using a cued-smoking procedure, which produces reliable increases in heart-rate and plasma THC. All marijuana cigarettes were administered in a double-blind fashion.
    Other Name: cannabis
  • Drug: High THC marijuana (3.9% THC)
    Active marijuana (3.9%) was administered using a cued-smoking procedure, which produces reliable increases in heart-rate and plasma THC. All marijuana cigarettes were administered in a double-blind fashion.
    Other Name: cannabis
Study Arms  ICMJE
  • Placebo Comparator: Inactive Marijuana (0, 1.8, or 3.9% THC)
    In this randomized, placebo-controlled study, every participant received all 3 treatment interventions in randomized order. Inactive marijuana (0% THC) served as a placebo comparator. Participants received an inactive marijuana cigarette (0% THC; provided by NIDA) in 1 of the 3 outpatient sessions in randomized order.
    Intervention: Drug: Inactive Marijuana (0% THC)
  • Experimental: Active Marijuana
    In this randomized, placebo-controlled study, every participant received all 3 treatment interventions in randomized order. Participants received active marijuana cigarettes (1.8, or 3.9% THC; provided by NIDA) over 2 of 3 outpatient sessions in randomized order.
    Interventions:
    • Drug: Low THC marijuana (1.8 %THC)
    • Drug: High THC marijuana (3.9% THC)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 4, 2018)
36
Original Enrollment  ICMJE
 (submitted: September 7, 2006)
30
Actual Study Completion Date  ICMJE March 2008
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Current marijuana use
  • 21-45 years of age
  • Practicing an effective form of birth control
  • Not seeking treatment for marijuana use

Exclusion Criteria:

  • Current, repeated illicit drug use other than marijuana
  • Presence of significant medical illness (e.g., diabetes, cardiovascular disease, hypertension)
  • Laboratory tests outside normal limits that are clinically unacceptable to the study physician (BP > 140/90; hematocrit < 34 for women, < 36 for men)
  • Significant adverse reaction to marijuana
  • Current parole or probation
  • Pregnancy or current lactation
  • Recent history of significant violent behavior
  • Major current Axis I psychopathology (e.g., mood disorder with functional impairment or suicide risk, anxiety disorder, schizophrenia
  • History of heart disease
  • Current use of any over-the-counter or prescription medication from which the volunteer cannot be withdrawn
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00373399
Other Study ID Numbers  ICMJE IRB# 5204
DA-03746 ( Other Grant/Funding Number: National Institute on Drug Abuse )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Margaret Haney, New York State Psychiatric Institute
Study Sponsor  ICMJE New York State Psychiatric Institute
Collaborators  ICMJE National Institute on Drug Abuse (NIDA)
Investigators  ICMJE
Principal Investigator: Margaret Haney, Ph.D. New York State Psychiatric Institute
Principal Investigator: Efrat Aharonovich, Ph.D. New York State Psyhciatric Institute
PRS Account New York State Psychiatric Institute
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP