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| ID | Type | Description | Link |
|---|---|---|---|
| MIRECC 00000000 | Registry Identifier | Veteran's Administration | |
| P50DA009241 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| VA Office of Research and Development | FED |
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| drug condition | Drug | Dronabinol (15mg) or Modafinil (400mg) or Dronabinol + Modafanil or placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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.
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). |
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Inclusion Criteria:
• Males and females between 18 and 55 years old will be eligible for this study.
Exclusion Criteria:
• History of heart disease, left ventricular hypertrophy, ischemic ECG changes, chest pain, arrhythmia, hypertension.
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| Name | Affiliation | Role |
|---|---|---|
| Mehmet Sofuoglu, M.D,Ph.D. | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Veterans Affairs Hospital | West Haven | Connecticut | 06516 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21176784 | Result | 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. | |
| 34532852 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Screening |
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| First Intervention |
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| Washout Period of GE 4 Days |
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| Second Intervention |
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| Washout Period of GE 4 Days |
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| Third Intervention |
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| Washout Period of GE 4 Days |
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| Fourth Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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.
The range is from -1 to +1 ; bad to good The numbers represent probabilities as units on a scale. | Subjects who completed all four treatment sessions. Three of these 15 subjects were not analyzed due to validity concerns of the cognitive data for at least one of the four testing sessions. | Posted | Mean | Standard Deviation | units on a scale | Once for each test session (4 total). |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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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
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mehmet Sofuoglu, M.D., Ph.D. | Yale University | 203-937-4809 | mehmet.sofuoglu@yale.edu |
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| ID | Term |
|---|---|
| D002189 | Marijuana Abuse |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D013759 | Dronabinol |
| D000077408 | Modafinil |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Session where THC+Modafinil was given.
| OG001 | THC+Placebo | Session where TCH and Placebo Modafinil were given |
| OG002 | Pla+Modafinil | Session where Placebo THC and Modafinil were given |
| OG003 | Placebo+Placebo | Session where placebo THC and Placebo Modafinil were given. |
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| 0 |
| 26 |
| 0 |
| 0 |
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| D001559 |
| Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |