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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA057252 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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This study will assess the age-dependent effects of smoked and oral THC on abuse liability, intoxication, analgesia and impairment as a function of age.
The overall objective of this placebo-controlled, outpatient study is to compare the dose-dependent effects of smoked and oral THC on analgesia and endpoints directly related to adverse consequences of use including abuse liability, intoxication, and impairment as a function of age and sex.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Comparator: Placebo | Placebo Comparator | Smoked Cannabis (0 mg THC) Oral placebo (0 mg THC) |
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| Experimental: Low strength cannabis | Experimental | Smoked Cannabis (10 mg THC) Oral placebo (0 mg THC) |
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| Experimental: Higher strength cannabis | Experimental | Smoked Cannabis (20 mg THC) Oral placebo (0 mg THC) |
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| Experimental: Low strength oral THC | Experimental | Smoked Cannabis (0 mg THC) Oral THC (10 mg THC) |
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| Experimental: Higher strength oral THC | Experimental | Smoked Cannabis (0 mg THC) Oral THC (20 mg THC) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabis | Drug | smoked cannabis |
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| Measure | Description | Time Frame |
|---|---|---|
| Subject-rated drug effects | Average and peak subjective ratings of drug effects associated with abuse liability and intoxication as measured using visual analogue scales (VAS; 1-100mm). | 6 hours |
| Analgesia as measured using the Cold Pressor Test | Peak and average pain threshold and tolerance assessed using the Cold Pressor Test | 6 hours |
| Impairment | The primary outcome measure for performance will be the peak difference from baseline scores of the Global Impairment Score | 6 hours |
| Pharmacokinetics of THC and metabolites | Plasma levels of THC, 11-OH-THC, and THCCOOH | 6 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ziva D Cooper, PhD | Contact | 310-983-3417 | zcooper@mednet.ucla.edu | |
| Vincent Acebo | Contact | 310-983-3417 | vacebo@mednet.ucla.edu |
| Name | Affiliation | Role |
|---|---|---|
| Ziva Cooper, PhD | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Center for Cannabis and Cannabinoids | Recruiting | Los Angeles | California | 90095 | United States |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D019966 | Substance-Related Disorders |
| D002189 | Marijuana Abuse |
| D003075 | Coitus |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D064419 | Chemically-Induced Disorders |
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| ID | Term |
|---|---|
| C587251 | nabiximols |
| D013759 | Dronabinol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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This is a randomized, double-blind, placebo-controlled study. All participants will complete all dose conditions in a randomized order.
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| Dronabinol | Drug | Oral delta-9-THC |
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| Smoked Placebo | Drug | Placebo Cannabis |
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| Oral Placebo | Drug | Oral Placebo |
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| D001523 | Mental Disorders |
| D012725 | Sexual Behavior |
| D001519 | Behavior |