Dronabinol Interactions in Humans - Full Text View

Sponsor:	Yale University
Collaborators:	Department of Veterans Affairs National Institute on Drug Abuse (NIDA)
Information provided by:	Yale University
ClinicalTrials.gov Identifier:	NCT00842985

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
Changes in Behavior Changes in Attitude	Drug: Modafinil or trade name is Provigil Drug: Dronabinol trade name Marinol Drug: Sugar pill/ placebo

Study Type:	Interventional
Study Design:	Allocation: Randomized 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:

MedlinePlus related topics: Drug Reactions

Drug Information available for: Modafinil Tetrahydrocannabinol

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:

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 ]

Enrollment:	15
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: modafinil modafinil will be given 400mg/per one of the 4 session	Drug: Modafinil or trade name is Provigil Modafinil 400mg
Experimental: Dronabinol Dronabinol 15mg per/1 of the 4 sessions	Drug: Dronabinol trade name Marinol Dronabinol 15mg
Experimental: Sugar Pill Sugar pill with modafinil	Drug: Sugar pill/ placebo Sugar pill will work in conjunction with modafinil

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

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

Department of Veterans Affairs

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Mehmet Sofuoglu, M.D,Ph.D.

Yale University

More Information

No publications provided

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
Last Updated:	April 4, 2011
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Tetrahydrocannabinol
Modafinil
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
Central Nervous System Stimulants
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on February 09, 2012