Dronabinol Interactions With Cognitive Enhancing Drug in Humans

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborators: National Institute on Drug Abuse (NIDA); VA Office of Research and Development
• Treatments: Armodafinil; Dronabinol; Modafinil

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.