Dronabinol Interactions in Humans

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Mehmet Sofuoglu, Yale University
ClinicalTrials.gov Identifier:
NCT00842985
First received: February 11, 2009
Last updated: November 15, 2012
Last verified: November 2012

February 11, 2009
November 15, 2012
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). ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00842985 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Dronabinol Interactions 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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Cannabis
  • Marijuana Abuse
  • Drug: Dronabinol + Modafinil
    Dronabinol (15mg)+ Modafinil (400mg)
    Other Names:
    • Marinol
    • Provigil
  • Drug: Dronabinol + Placebo
    Dronabinol (15mg) + Placebo Modafinil
    Other Name: Marinol
  • Drug: Placebo + Modafinil
    Placebo Dronabinol + Modafinil (400mg)
    Other Name: Provigil
  • Drug: Placebo + Placebo
    Placebo Dronabinol + Placebo Modafinil
    Other Name: Placebo
Experimental: All Participants

There were 4 sessions given in a counterbalanced order: Dronabinol+Modafinil, Dronabinol+Placebo, Placebo+Modafinil, Placebo+Placebo.

Not all participants received the interventions in the same order.

Interventions:
  • Drug: Dronabinol + Modafinil
  • Drug: Dronabinol + Placebo
  • Drug: Placebo + Modafinil
  • Drug: Placebo + Placebo
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
53
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.
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00842985
0702002357, MIRECC 00000000, P50DA009241
Yes
Mehmet Sofuoglu, Yale University
Yale University
  • Department of Veterans Affairs
  • National Institute on Drug Abuse (NIDA)
Principal Investigator: Mehmet Sofuoglu, M.D,Ph.D. Yale University
Yale University
November 2012

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