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
  Purpose

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.


Condition Intervention
Cannabis
Marijuana Abuse
Drug: Dronabinol + Modafinil
Drug: Dronabinol + Placebo
Drug: Placebo + Modafinil
Drug: Placebo + Placebo

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Dronabinol Interactions in Humans

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • 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.



Enrollment: 53
Study Start Date: September 2008
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  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: NCT00842985

Locations
United States, Connecticut
Department of Veterans Affairs Hospital
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Mehmet Sofuoglu, M.D,Ph.D. Yale University
  More Information

Publications:
Responsible Party: Mehmet Sofuoglu, M.D., Ph.D., Yale University
ClinicalTrials.gov Identifier: NCT00842985     History of Changes
Other Study ID Numbers: 0702002357, MIRECC 00000000, P50DA009241
Study First Received: February 11, 2009
Results First Received: August 5, 2011
Last Updated: November 15, 2012
Health Authority: United States: Federal Government

Keywords provided by Yale University:
Cannabis Abuse
Cannabis Dependence
Cannabis-Related Disorder
Marijuana Dependence
Marihuana Abuse

Additional relevant MeSH terms:
Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Dronabinol
Modafinil
Armodafinil
Hallucinogens
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Wakefulness-Promoting Agents
Central Nervous System Stimulants

ClinicalTrials.gov processed this record on August 19, 2014