Dronabinol Interactions With Cognitive Enhancing Drug in Humans

NCT00842985 | Completed Early Phase 1 Results DMC

• 3 other identifiers: 0702002357MIRECC 00000000P50DA009241
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Cannabis; Marijuana Abuse

Keywords

Cannabis Abuse; Cannabis Dependence; Cannabis-Related Disorder; Marijuana Dependence; Marihuana Abuse

Outcome Measures

Primary Outcomes (1)

• 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. 1. RVP A' ( Target sensitivity, a measure of the ability to detect sequences.) The range is from 0-1; bad to good. 2. 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).

Study Arms (1)

drug condition

OTHER

Participants received each drug condition in sequential order across 4 test days. Not all participants received the interventions in the same order.

Drug: drug condition

Interventions

drug condition DRUG

Dronabinol (15mg) or Modafinil (400mg) or Dronabinol + Modafanil or placebo

Also known as: Marinol, Provigil,

drug condition

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• VA Office of Research and Development: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Department of Veterans Affairs Hospital

West Haven, Connecticut, 06516, United States

Location

Related Publications (2)

• 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.

  PMID: 21176784 RESULT

• 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.

  PMID: 34532852 DERIVED

MeSH Terms

Conditions

Marijuana Abuse

Interventions

Dronabinol; Modafinil

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Limitations and Caveats

One dose of modafinil Brief treatment duration and use of a low dose of THC Cognitive testing assessed only two tasks. Outcome measures were limited by small sample size. Limited generalizability because heavy cannibas users were excluded

Results Point of Contact

• Title: Mehmet Sofuoglu, M.D., Ph.D.
• Organization: Yale University

mehmet.sofuoglu@yale.edu

203-937-4809

Study Officials

• Mehmet Sofuoglu, M.D,Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D.

Study Record Dates

• First Submitted: February 11, 2009
• First Posted: February 12, 2009
• Study Start: September 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: May 30, 2017
• Results First Posted: December 17, 2012

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)