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Effects of Smoked Marijuana on Risk Taking and Decision Making Tasks

NCT ID: NCT00373399

Last Updated: 2018-12-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2008-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Marijuana Use Disorder

Keywords

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Cannabinoids Risk taking Decision making

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators
Double-blind, placebo-controlled

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

Inactive Marijuana (0% THC)

Intervention Type DRUG

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.

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.

Group Type EXPERIMENTAL

Low THC marijuana (1.8 %THC)

Intervention Type DRUG

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.

High THC marijuana (3.9% THC)

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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placebo marijuana cannabis cannabis

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

New York State Psychiatric Institute

OTHER

Sponsor Role lead

Responsible Party

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Margaret Haney

Associate Professor of Clinical Psychology (in Psychiatry)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Margaret Haney, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

New York State Psychiatric Institute

Efrat Aharonovich, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

New York State Psyhciatric Institute

Locations

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New York State Psychiatric Institute

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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DA-03746

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB# 5204

Identifier Type: -

Identifier Source: org_study_id