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Effects of Smoked Marijuana on Risk Taking and Decision Making Tasks

This study has been completed.
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00373399
First received: September 7, 2006
Last updated: October 25, 2016
Last verified: October 2016
  Purpose
The purpose of this study is to investigate the effects of smoked marijuana on both risk taking and decision making tasks.

Condition Intervention Phase
Marijuana Use Disorders
Drug: Marijuana
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Smoked Marijuana on Risk Taking and Decision Making Tasks

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • After smoking marijuana participants will demonstrate poorer decision-making abilities and increased risk-taking behaviors. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 278
Study Start Date: May 2006
Study Completion Date: March 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: marijuana Drug: Marijuana
Marijuana (0, 1.98, 3.56% THC), provided by the National Institute of Drug Abuse) was administered using a cued-smoking procedure, which produces reliable increases in heart-rate and plasma Δ9 THC. Each participant smoked each dose of mariuana on separate study days in this within-subject design.
Placebo Comparator: placebo Drug: Marijuana
Marijuana (0, 1.98, 3.56% THC), provided by the National Institute of Drug Abuse) was administered using a cued-smoking procedure, which produces reliable increases in heart-rate and plasma Δ9 THC. Each participant smoked each dose of mariuana on separate study days in this within-subject design.

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, 3.56% 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.
  Eligibility

Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00373399

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: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00373399     History of Changes
Other Study ID Numbers: 5204 
Study First Received: September 7, 2006
Last Updated: October 25, 2016
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by New York State Psychiatric Institute:
Cannabinoids
Risk taking
Decision making

Additional relevant MeSH terms:
Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on December 09, 2016