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 Description

Brief Summary:

The purpose of this study is to investigate the effects of smoked marijuana on both risk taking and decision making tasks.

Condition or disease	Intervention/treatment	Phase
Marijuana Use Disorder	Drug: Inactive Marijuana (0% THC); Drug: Low THC marijuana (1.8 %THC); Drug: High THC marijuana (3.9% THC)	Phase 1

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Masking Description: Double-blind, placebo-controlled
• Primary Purpose: Basic Science
• Official Title: Acute Effects of Smoked Marijuana on Decision Making, as Assessed by a Modified Gambling Task, in Experienced Marijuana Users
• Study Start Date: May 2006
• Actual Primary Completion Date: March 2008
• Actual Study Completion Date: March 2008

Arms and Interventions

Arm	Intervention/treatment
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.	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
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.	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

Outcome Measures

Primary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 45 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

United States, New York

New York State Psychiatric Institute

New York, New York, United States, 10032

Sponsors and Collaborators

New York State Psychiatric Institute

National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: Margaret Haney, Ph.D.; New York State Psychiatric Institute
• Principal Investigator: Efrat Aharonovich, Ph.D.; New York State Psyhciatric Institute

More Information

• Responsible Party: Margaret Haney, Associate Professor of Clinical Psychology (in Psychiatry), 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 Posted: September 8, 2006
• Results First Posted: October 31, 2018
• Last Update Posted: December 19, 2018
• Last Verified: November 2018

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Margaret Haney, New York State Psychiatric Institute:

Cannabinoids; Risk taking; Decision making

Additional relevant MeSH terms:

Marijuana Abuse; Marijuana Use; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Dronabinol; Hallucinogens; Physiological Effects of Drugs; Psychotropic Drugs; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Cannabinoid Receptor Agonists; Cannabinoid Receptor Modulators; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists