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Dronabinol Interactions With Cognitive Enhancing Drug in Humans

Primary Purpose

Cannabis, Marijuana Abuse

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
drug condition
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cannabis focused on measuring Cannabis Abuse, Cannabis Dependence, Cannabis-Related Disorder, Marijuana Dependence, Marihuana Abuse

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Veterans Affairs Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

drug condition

Arm Description

Participants received each drug condition in sequential order across 4 test days. Not all participants received the interventions in the same order.

Outcomes

Primary Outcome Measures

CANTAB:CAmbridge Neuropsychological Test Automated Battery RVIP: Rapid Visual Information Processing
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. RVP A' ( Target sensitivity, a measure of the ability to detect sequences.) The range is from 0-1; bad to good. 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.

Secondary Outcome Measures

Full Information

First Posted
February 11, 2009
Last Updated
April 21, 2017
Sponsor
Yale University
Collaborators
VA Office of Research and Development, National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00842985
Brief Title
Dronabinol Interactions With Cognitive Enhancing Drug in Humans
Official Title
Dronabinol Interactions in Humans
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yale University
Collaborators
VA Office of Research and Development, National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cannabis, Marijuana Abuse
Keywords
Cannabis Abuse, Cannabis Dependence, Cannabis-Related Disorder, Marijuana Dependence, Marihuana Abuse

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
drug condition
Arm Type
Other
Arm Description
Participants received each drug condition in sequential order across 4 test days. Not all participants received the interventions in the same order.
Intervention Type
Drug
Intervention Name(s)
drug condition
Other Intervention Name(s)
Marinol, Provigil,
Intervention Description
Dronabinol (15mg) or Modafinil (400mg) or Dronabinol + Modafanil or placebo
Primary Outcome Measure Information:
Title
CANTAB:CAmbridge Neuropsychological Test Automated Battery RVIP: Rapid Visual Information Processing
Description
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. RVP A' ( Target sensitivity, a measure of the ability to detect sequences.) The range is from 0-1; bad to good. 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.
Time Frame
Once for each test session (4 total).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mehmet Sofuoglu, M.D,Ph.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Veterans Affairs Hospital
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21176784
Citation
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.
Results Reference
result
PubMed Identifier
34532852
Citation
Bosnjak Kuharic D, Markovic D, Brkovic T, Jeric Kegalj M, Rubic Z, Vuica Vukasovic A, Jeroncic A, Puljak L. Cannabinoids for the treatment of dementia. Cochrane Database Syst Rev. 2021 Sep 17;9(9):CD012820. doi: 10.1002/14651858.CD012820.pub2.
Results Reference
derived

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Dronabinol Interactions With Cognitive Enhancing Drug in Humans

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