Status:
COMPLETED
Dronabinol Interactions With Cognitive Enhancing Drug in Humans
Lead Sponsor:
Yale University
Collaborating Sponsors:
VA Office of Research and Development
National Institute on Drug Abuse (NIDA)
Conditions:
Cannabis
Marijuana Abuse
Eligibility:
All Genders
18-55 years
Phase:
EARLY_PHASE1
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 b...
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 ...
Eligibility Criteria
Inclusion
- • 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
- • 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00842985
Start Date
September 1 2008
End Date
October 1 2009
Last Update
May 30 2017
Active Locations (1)
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1
Department of Veterans Affairs Hospital
West Haven, Connecticut, United States, 06516