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| ID | Type | Description | Link |
|---|---|---|---|
| 93304 | Other Grant/Funding Number | CA Department of Cannabis Control |
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| Name | Class |
|---|---|
| California Department of Cannabis Control (DCC) | UNKNOWN |
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The purpose of this research is to assess the effects of smoked cananbis when cannabis is smoked during periods of cannabis use as usual and after a brief period of abstinence.
This outpatient study will assess the acute pharmacodynamic effects of smoked cannabis with ~50 mg and ~100 mg THC compared to placebo (~0 mg THC) and whether a brief period of abstinence alters these effects. Metabolism (pharmacokinetics) of THC will be examined to associate behavioral and physiological effects to plasma concentrations of THC and metabolites.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Comparator: Placebo | Placebo Comparator | 0 mg THC |
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| Low dose THC | Active Comparator | 50 mg THC |
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| High dose THC | Active Comparator | 100 mg THC |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo Comparator: Placebo | Drug | Placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| Subject-rated drug effects of abuse liability | Subject ratings of "Good Drug Effect" as measured using a visual analog scale (1-100 mm) | 3 hours |
| Analgesia as measured using the Cold Pressor Test | Pain threshold assessed using the Cold Pressor Test (percent baseline) | 3 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of THC and metabolites | Peak plasma levels of THC (ng/ml) | 3 hours |
| Pharmacokinetics of THC and metabolites | Peak plasma levels of 11-OH-THC (ng/ml) |
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Inclusion Criteria:
• Male or non-pregnant and non-lactating females aged 21-55 years
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ziva Cooper, PhD | Contact | 310-206-9942 | cannabislab@mednet.ucla.edu | |
| Vincent Acebo | Contact | 310-983-3417 | vacebo@mednet.ucla.edu |
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| 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 |
|---|---|
| D002189 | Marijuana Abuse |
| D010146 | Pain |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D009461 | Neurologic Manifestations |
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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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| Low dose THC | Drug | Smoked low dose THC |
|
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| High dose THC | Drug | Smoked high dose THC |
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| 3 hours |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |