Clinical trial NCT00842985: Dronabinol Interactions With Cognitive Enhancing Drug in Humans
Official title: Dronabinol Interactions in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Cannabis
Marijuana Abuse
Keywords: Cannabis Abuse
Cannabis Dependence
Cannabis-Related Disorder
Marijuana Dependence
Marihuana Abuse
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: VA Office of Research and Development
name: National Institute on Drug Abuse (NIDA)
First posted: 2009-02-12
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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 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.

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.

Currently this study complete and has been published.

Eligibility 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.

Primary outcomes:
measure: CANTAB:CAmbridge Neuropsychological Test Automated Battery RVIP: Rapid Visual Information Processing
timeFrame: Once for each test session (4 total).
Secondary outcomes:
Other outcomes:
Locations:
city: West Haven
country: United States
facility: Department of Veterans Affairs Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Mehmet Sofuoglu, M.D,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Bosnjak Kuharic D, Markovic D, Brkovic T, Jeric Kegalj M, Rubic Z, Vuica Vukasovic A, Jeroncic A, Puljak L. Cannabinoids for the treatment of dementia. Cochrane Database Syst Rev. 2021 Sep 17;9(9):CD012820. doi: 10.1002/14651858.CD012820.pub2.