Dronabinol Interactions in Humans

Cannabis Clinical Trial

Official title:

Dronabinol Interactions in Humans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00842985
• Other study ID #: 0702002357
• Secondary ID: MIRECC 00000000P
• Status: Completed
• Phase: N/A
• First received: February 11, 2009
• Last updated: November 15, 2012
• Start date: September 2008
• Est. completion date: October 2009

Study information

• Verified date: November 2012
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cannabis
• Marijuana Abuse

Intervention

Drug:
• Dronabinol + Modafinil
Dronabinol (15mg)+ Modafinil (400mg)
• Dronabinol + Placebo
Dronabinol (15mg) + Placebo Modafinil
• Placebo + Modafinil
Placebo Dronabinol + Modafinil (400mg)
• Placebo + Placebo
Placebo Dronabinol + Placebo Modafinil

Locations

Country	Name	City	State
United States	Department of Veterans Affairs Hospital	West Haven	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA), VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Once for each test session (4 total).	No