Cannabis, Marijuana Abuse
Conditions
Keywords
Cannabis Abuse, Cannabis Dependence, Cannabis-Related Disorder, Marijuana Dependence, Marihuana Abuse
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.
Interventions
DRUGdrug condition
Dronabinol (15mg) or Modafinil (400mg) or Dronabinol + Modafanil or placebo
Sponsors
VA Office of Research and Development
National Institute on Drug Abuse (NIDA)
Yale University
Study design
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CANTAB:CAmbridge Neuropsychological Test Automated Battery RVIP: Rapid Visual Information Processing | Once for each test session (4 total). | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 53 |
| Total | 53 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| First Intervention | Protocol Violation | 3 |
| First Intervention | Withdrawal by Subject | 3 |
| Screening | Did not meet entrance requirements | 27 |
| Washout Period of GE 4 Days | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 53 Participants |
| Age, Continuous | 33.7 years STANDARD_DEVIATION 7.7 |
| Region of Enrollment United States | 53 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 26 |
Outcome results
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. 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.
Time frame: Once for each test session (4 total).
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| THC+Modafinil | CANTAB:CAmbridge Neuropsychological Test Automated Battery RVIP: Rapid Visual Information Processing | 0.91 units on a scale | Standard Deviation 0.1 |
| THC+Placebo | CANTAB:CAmbridge Neuropsychological Test Automated Battery RVIP: Rapid Visual Information Processing | 0.9 units on a scale | Standard Deviation 0.1 |
| Pla+Modafinil | CANTAB:CAmbridge Neuropsychological Test Automated Battery RVIP: Rapid Visual Information Processing | 0.92 units on a scale | Standard Deviation 0.1 |
| Placebo+Placebo | CANTAB:CAmbridge Neuropsychological Test Automated Battery RVIP: Rapid Visual Information Processing | 0.9 units on a scale | Standard Deviation 0.1 |