Dronabinol Interactions With Cognitive Enhancing Drug in Humans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00842985
Recruitment Status : Completed
First Posted : February 12, 2009
Results First Posted : December 17, 2012
Last Update Posted : May 30, 2017
VA Office of Research and Development
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Mehmet Sofuoglu, Yale University

February 11, 2009
February 12, 2009
August 5, 2011
December 17, 2012
May 30, 2017
September 2008
October 2009   (Final data collection date for primary outcome measure)
CANTAB:CAmbridge Neuropsychological Test Automated Battery RVIP: Rapid Visual Information Processing [ Time Frame: Once for each test session (4 total). ]

CANTAB RVIP is one component of this computerized battery and is a measure of sustained attention with a working memory component.

This study used two subscales of the RVIP.

  1. RVP A' ( Target sensitivity, a measure of the ability to detect sequences.) The range is from 0-1; bad to good.
  2. RVP B'' ( Response bias, which is a measure of the tendency to respond regardless of whether a target is present.

The range is from -1 to +1 ; bad to good

The numbers represent probabilities as units on a scale.

Heart rate will be continuously observed using a cardiac monitor. Automatic blood pressure monitoring will be made using a Dynamap Blood Pressure Monitoring System Device. As well as drug and cognitive scales [ Time Frame: Each session ]
Complete list of historical versions of study NCT00842985 on Archive Site
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Dronabinol Interactions With Cognitive Enhancing Drug in Humans
Dronabinol Interactions in Humans

Marijuana use is a major problem among veterans and non-veterans. A patient's use of marijuana while engaged in psychotherapy treatment may affect their memory and, therefore, limit their ability to benefit from treatment. This study is designed to test a new pharmacotherapy, modafinil, which has the potential to improve memory functioning in marijuana using individuals.

We hypothesize that modafinil treatment will decrease ratings of drug liking and improve cognitive measures, especially episodic memory.

The impairment of episodic memory in marijuana abusers has important treatment implications. Since many treatments, including cognitive-behavioral therapy, strongly utilize episodic memory, marijuana use during treatment may lead to diminished treatment outcomes. In addition, lessened response inhibition may lead to elevated rates of drug relapse while in treatment. Consequently, a treatment which will improve episodic memory and response inhibition may lead to improved treatment outcomes in marijuana users. One such treatment is modafinil.This study will be a 4 session within-subjects, double-blind, crossover study evaluating the impact of modafinil (400 mg/day) on the cognitive, subjective, and physiological effects of marijuana. Across 4 sessions, subjects will be randomly assigned to receive either oral placebo, modafinil (400mg), dronabinol (15mg), or dronabinol and modafinil. Outcome measures will include physiological, cognitive, and subjective drug effects.

Currently this study complete and has been published.

Early Phase 1
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Cannabis
  • Marijuana Abuse
Drug: drug condition
Dronabinol (15mg) or Modafinil (400mg) or Dronabinol + Modafanil or placebo
Other Name: Marinol, Provigil,
drug condition
Participants received each drug condition in sequential order across 4 test days. Not all participants received the interventions in the same order.
Intervention: Drug: drug condition
Sugarman DE, Poling J, Sofuoglu M. The safety of modafinil in combination with oral ∆9-tetrahydrocannabinol in humans. Pharmacol Biochem Behav. 2011 Mar;98(1):94-100. doi: 10.1016/j.pbb.2010.12.013. Epub 2010 Dec 21.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 2009
October 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • • Males and females between 18 and 55 years old will be eligible for this study.

    • Marijuana used at least once in last 2 months and at least 10 times in lifetime.
    • Subjects do not meet DSM-IV criteria for marijuana abuse or dependence.
    • Subjects are NOT seeking treatment for substance abuse or dependence.
    • Females must not be pregnant as determined by pregnancy screening, nor breast feeding, and must be using acceptable birth control methods other than oral contraceptive pills (OCP). Modafinil may cause OCP to be ineffective. Acceptable forms of birth control are condoms, diaphragms, and IUDs.
    • No alcohol or drugs 24 hours prior to testing session.
    • Subjects must agree to not drive to or from session.

Exclusion Criteria:

  • • History of heart disease, left ventricular hypertrophy, ischemic ECG changes, chest pain, arrhythmia, hypertension.

    • History of severe renal or hepatic diseases.
    • History of psychosis, schizophrenia or bipolar type I disorder.
    • History of seizure disorder.
    • Current diagnosis of alcohol and other drug dependence (other than nicotine).
    • A positive urine toxicology result for cocaine or opiates at intake.
    • Current use of over-the-counter or prescription psychoactive drugs (antidepressant, anxiolytics, antipsychotics, mood stabilizers, psychostimulants).
    • Liver function tests (ALT or AST) greater than 3 times normal.
    • Known allergy to modafinil or dronabinol.
Sexes Eligible for Study: All
18 Years to 55 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
MIRECC 00000000 ( Registry Identifier: Veteran's Administration )
P50DA009241 ( U.S. NIH Grant/Contract )
Not Provided
Plan to Share IPD: No
Mehmet Sofuoglu, Yale University
Yale University
  • VA Office of Research and Development
  • National Institute on Drug Abuse (NIDA)
Principal Investigator: Mehmet Sofuoglu, M.D,Ph.D. Yale University
Yale University
April 2017

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