Effects of Smoked Marijuana on Risk Taking and Decision Making Tasks

NCT00373399 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: IRB# 5204DA-03746
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Marijuana Use Disorder

Keywords

Cannabinoids; Risk taking; Decision making

Outcome Measures

Primary Outcomes (1)

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

  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.

  3 weeks

Study Arms (2)

Inactive Marijuana (0, 1.8, or 3.9% THC)

PLACEBO COMPARATOR

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)

Active Marijuana

EXPERIMENTAL

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); Drug: High THC marijuana (3.9% THC)

Interventions

Inactive Marijuana (0% THC) 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.

Also known as: placebo marijuana

Inactive Marijuana (0, 1.8, or 3.9% THC)

Low THC marijuana (1.8 %THC) 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.

Also known as: cannabis

Active Marijuana

High THC marijuana (3.9% THC) 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.

Also known as: cannabis

Active Marijuana

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Risk-Taking

Interventions

Dronabinol; nabiximols

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Margaret Haney
• Organization: New York State Psychiatric Institute

mh235@cumc.columbia.edu

646-774-6153

Study Officials

• Margaret Haney, Ph.D.

  New York State Psychiatric Institute

  PRINCIPAL INVESTIGATOR

• Efrat Aharonovich, Ph.D.

  New York State Psyhciatric Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind, placebo-controlled
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical Psychology (in Psychiatry)

Study Record Dates

• First Submitted: September 7, 2006
• First Posted: September 8, 2006
• Study Start: May 1, 2006
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: December 19, 2018
• Results First Posted: October 31, 2018

Record last verified: 2018-11

Locations

US (1)