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This study will examine the effects of oral dronabinol tetrahydrocannabinol (THC) on withdrawal symptoms in marijuana dependent volunteers, and evaluate the safety, pharmacokinetics (PK), and cardiovascular effects of the combination of oral dronabinol and smoked marijuana to determine if there are potential significant drug interactions before conducting outpatient studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dronabinol | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug |
|
| |
| Dronabinol |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants That Experience Cardiovascular Effects of Smoked Marijuana or Has Any Other Combination Side Effects. | Does dronabinol (when given during smoking of a marijuana cigarette) show changes in the number of participants that experience cardiovascular effects of smoked marijuana or has any other combination side effects. | Day 9 and 10 |
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Inclusion Criteria:
Exclusion
Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Louis Cantilena, M.D. | Uniformed Services University of Health Science | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uniformed Services University of Health Science | Bethesda | Maryland | 20814 4799 | United States |
Volunteers meeting the maximum 28-day screening assessment period and eligibility criteria were enrolled into the Phase-1 clinical trial. The subjects had to meet the following criteria to be eligible: be non-treatment seeking, experienced marijuana users with dependence for the past year, and subjects that were in good general health.
Recruitment was from October 31, 2006 to December 5, 2007. The study was conducted at the NIDA funded clinical pharmacology unit (CPU) at Uniformed Services University for the Health Sciences (USUHS).
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| ID | Title | Description |
|---|---|---|
| FG000 | Dronabinol | Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800. |
| FG001 | Placebo | Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dronabinol Then Placebo |
| |||||||||||||
| Placebo Then Dronabinol |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dronabinol | Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Number of Participants That Experience Cardiovascular Effects of Smoked Marijuana or Has Any Other Combination Side Effects. | Does dronabinol (when given during smoking of a marijuana cigarette) show changes in the number of participants that experience cardiovascular effects of smoked marijuana or has any other combination side effects. | Posted | Number | participants | Day 9 and 10 |
|
Adverse events were collected starting on Day 0 through Day 12
If a subject experienced more than one adverse events (AE), it would be recorded as a separate AE.
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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 | Dronabinol | Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety Disorder | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Lou Cantelina | Uniformed Services University for the Health Sciences | 301-295-3240 | louis.cantelina@usuhs.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 |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Drug |
|
|
| NOT COMPLETED |
|
| BG001 |
| Placebo |
Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800. |
|
|
| 1 |
| 6 |
| 6 |
| 6 |
| EG001 | Placebo | Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800. | 0 | 6 | 1 | 6 |
| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment | Mild adverse event; possibly related to study drug. |
|
| Fatigue | General disorders | MedDRA (10.0) | Non-systematic Assessment | Mild adverse event; possibly related to study drug. |
|
| Catheter site hemmorage | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Catheter site adema | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Injection site inflammation | General disorders | MedDRA (10.0) | Systematic Assessment |
|
| Transamenase Increase | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment | Moderate adverse event; possibly related to study drug. |
|
| Decrease in Appetite (NOS) | Metabolism and nutrition disorders | MedDRA (10.0) | Non-systematic Assessment | Mild adverse event; possibly related to study drug. |
|
| Headache | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment | Mild adverse event; possibly related to study drug. |
|
| Syncope | Nervous system disorders | MedDRA (10.0) | Systematic Assessment | Moderate adverse event, remotely related to study drug. |
|
| Insomnolence | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment | Mild adverse event; possibly related to study drug. |
|
| Anxiety | Psychiatric disorders | MedDRA (10.0) | Non-systematic Assessment | Moderate adverse even; probably related to study drug. |
|
| Anxiety disorders and symptoms | Psychiatric disorders | MedDRA (10.0) | Non-systematic Assessment | Mild adverse event; possibly related to study drug. |
|
| Irritability | Psychiatric disorders | MedDRA (10.0) | Non-systematic Assessment | Mild adverse event; possibly related to study drug. |
|
| Polymenorrhea | Reproductive system and breast disorders | MedDRA (10.0) | Systematic Assessment | Mild adverse event and possibly related to study drug. |
|
| Lip ulceration | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment |
|
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