Dronabinol Interactions in Humans
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.
Drug: Dronabinol + Modafinil
Drug: Dronabinol + Placebo
Drug: Placebo + Modafinil
Drug: Placebo + Placebo
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Dronabinol Interactions in Humans|
- CANTAB:CAmbridge Neuropsychological Test Automated Battery RVIP: Rapid Visual Information Processing [ Time Frame: Once for each test session (4 total). ] [ Designated as safety issue: No ]
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.
|Study Start Date:||September 2008|
|Study Completion Date:||October 2009|
|Primary Completion Date:||October 2009 (Final data collection date for primary outcome measure)|
Experimental: All Participants
There were 4 sessions given in a counterbalanced order: Dronabinol+Modafinil, Dronabinol+Placebo, Placebo+Modafinil, Placebo+Placebo.
Not all participants received the interventions in the same order.
Drug: Dronabinol + Modafinil
Dronabinol (15mg)+ Modafinil (400mg)
Other Names:Drug: Dronabinol + Placebo
Dronabinol (15mg) + Placebo Modafinil
Other Name: MarinolDrug: Placebo + Modafinil
Placebo Dronabinol + Modafinil (400mg)
Other Name: ProvigilDrug: Placebo + Placebo
Placebo Dronabinol + Placebo Modafinil
Other Name: Placebo
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00842985
|United States, Connecticut|
|Department of Veterans Affairs Hospital|
|West Haven, Connecticut, United States, 06516|
|Principal Investigator:||Mehmet Sofuoglu, M.D,Ph.D.||Yale University|