Dronabinol Interactions With Cognitive Enhancing Drug in Humans

April 21, 2017 updated by: Mehmet Sofuoglu, Yale University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • West Haven, Connecticut, United States, 06516
        • Department of Veterans Affairs Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Interventional Model: SEQUENTIAL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: drug condition
Participants received each drug condition in sequential order across 4 test days. Not all participants received the interventions in the same order.
Drug: drug condition
Dronabinol (15mg) or Modafinil (400mg) or Dronabinol + Modafanil or placebo
Other Names:
  • Marinol, Provigil,

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Once for each test session (4 total).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

National Institute on Drug Abuse (NIDA)
VA Office of Research and Development

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (ACTUAL)

October 1, 2009

Study Completion (ACTUAL)

October 1, 2009

Study Registration Dates

First Submitted

February 11, 2009

First Submitted That Met QC Criteria

February 11, 2009

First Posted (ESTIMATE)

February 12, 2009

Study Record Updates

Last Update Posted (ACTUAL)

May 30, 2017

Last Update Submitted That Met QC Criteria

April 21, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0702002357
  • P50DA009241 (U.S. NIH Grant/Contract)
  • MIRECC 00000000 (REGISTRY: Veteran's Administration)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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