Dronabinol Interactions in Humans

Condition(s) targeted: Changes in Behavior; Changes in Attitude

Intervention: Modafinil or trade name is Provigil (Drug); Dronabinol trade name Marinol (Drug); Sugar pill/ placebo (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: National Institute on Drug Abuse (NIDA)

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.

Official title: Dronabinol Interactions in Humans

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Safety/Efficacy Study

Primary outcome: 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

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.

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

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.

Department of Veterans Affairs Hospital, West Haven,, Connecticut 06516, United States; Recruiting
James Poling, Ph.D, Phone: 203-932-5711, Ext: 4830, Email: james.poling@yale.edu
James Poling, PH.D., Principal Investigator

Starting date: September 2008
Ending date: February 2012
Last updated: September 15, 2009