Laboratory Study of Cannabidiol on the Effects of Smoked Marijuana

Study Overview
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Brief Summary
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The objective of this study is to assess the effects of oral cannabidiol (CBD; 0, 200, 400, 800 mg) on smoked marijuana's (0, 5.6% THC) subjective, reinforcing, cognitive, and cardiovascular effects. This experiment is expected to reveal CBD's intrinsic effects when combined with placebo marijuana, as well as its ability to modulate the behavioral effects of active marijuana.

Detailed Description
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Marijuana contains many chemicals called cannabinoids. The ingredient mainly responsible for marijuana's psychoactive effects is called THC (delta-9-tetrahydrocannabinol. Another cannabinoid in marijuana is cannabidiol. It is found in smaller quantities than THC. Cannabidiol is thought to interfere with the effects of THC. Therefore, synthetically produced cannabidiol is given to healthy marijuana users in this study to test its capability to reduce the high of THC and, thereby, help to relieve addiction to marijuana.

Official Title
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Laboratory Study of the Influence of Oral Cannabidiol on the Subjective, Reinforcing and Cardiovascular Effects of Smoked Marijuana

Conditions
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Smoking, Marijuana

Intervention / Treatment
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* Drug: CBD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults between the ages of 18 and 50. Current marijuana use: Minimum of four times per week, 0.5 joints per occasion during the preceding 4 weeks. Able to perform study procedures Women practicing an effective form of birth control Exclusion Criteria: Female subjects who are currently pregnant or breastfeeding. Current, repeated illicit drug use other than marijuana Presence of significant medical illness History of heart disease Request for drug treatment Current parole or probation Recent history of significant violent behavior Major psychiatric disorder

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Active marijuana (MJ) with 0 mg CBD<br>Active MJ cigarettes contain 5.30% THC | Drug: CBD<br>* Each subject in the study was tested on eight days, each day receiving a different combination of active/inactive cannabis cigarettes plus 0, 200, 400 or 800 mg of CBD in random order. Cigarettes contained either 0.01 or 5.30% THC. At each visit, participants were given four gelatin capsules containing lactose and 0 or 200 mg of CBD in combinations to achieve scheduled dose level.<br>* Other names: cannabidiol is abbreviated CBD;|
| Other: Active MJ with 200 mg CBD<br>Active MJ cigarettes contain 5.30% THC | Drug: CBD<br>* Each subject in the study was tested on eight days, each day receiving a different combination of active/inactive cannabis cigarettes plus 0, 200, 400 or 800 mg of CBD in random order. Cigarettes contained either 0.01 or 5.30% THC. At each visit, participants were given four gelatin capsules containing lactose and 0 or 200 mg of CBD in combinations to achieve scheduled dose level.<br>* Other names: cannabidiol is abbreviated CBD;|
| Other: Active MJ with 400 mg CBD<br>Active MJ cigarettes contain 5.30% THC | Drug: CBD<br>* Each subject in the study was tested on eight days, each day receiving a different combination of active/inactive cannabis cigarettes plus 0, 200, 400 or 800 mg of CBD in random order. Cigarettes contained either 0.01 or 5.30% THC. At each visit, participants were given four gelatin capsules containing lactose and 0 or 200 mg of CBD in combinations to achieve scheduled dose level.<br>* Other names: cannabidiol is abbreviated CBD;|
| Other: Active MJ with 800 mg CBD<br>Active MJ cigarettes contain 5.30% THC | Drug: CBD<br>* Each subject in the study was tested on eight days, each day receiving a different combination of active/inactive cannabis cigarettes plus 0, 200, 400 or 800 mg of CBD in random order. Cigarettes contained either 0.01 or 5.30% THC. At each visit, participants were given four gelatin capsules containing lactose and 0 or 200 mg of CBD in combinations to achieve scheduled dose level.<br>* Other names: cannabidiol is abbreviated CBD;|
| Other: Inactive MJ with 0 mg CBD<br>Inactive MJ cigarettes contain 0.01% THC | Drug: CBD<br>* Each subject in the study was tested on eight days, each day receiving a different combination of active/inactive cannabis cigarettes plus 0, 200, 400 or 800 mg of CBD in random order. Cigarettes contained either 0.01 or 5.30% THC. At each visit, participants were given four gelatin capsules containing lactose and 0 or 200 mg of CBD in combinations to achieve scheduled dose level.<br>* Other names: cannabidiol is abbreviated CBD;|
| Other: Inactive MJ with 200 mg CBD<br>Inactive MJ cigarettes contain 0.01% THC | Drug: CBD<br>* Each subject in the study was tested on eight days, each day receiving a different combination of active/inactive cannabis cigarettes plus 0, 200, 400 or 800 mg of CBD in random order. Cigarettes contained either 0.01 or 5.30% THC. At each visit, participants were given four gelatin capsules containing lactose and 0 or 200 mg of CBD in combinations to achieve scheduled dose level.<br>* Other names: cannabidiol is abbreviated CBD;|
| Other: Inactive MJ with 400 mg CBD<br>Inactive MJ cigarettes contain 0.01% THC | Drug: CBD<br>* Each subject in the study was tested on eight days, each day receiving a different combination of active/inactive cannabis cigarettes plus 0, 200, 400 or 800 mg of CBD in random order. Cigarettes contained either 0.01 or 5.30% THC. At each visit, participants were given four gelatin capsules containing lactose and 0 or 200 mg of CBD in combinations to achieve scheduled dose level.<br>* Other names: cannabidiol is abbreviated CBD;|
| Other: Inactive MJ with 800 mg CBD<br>Inactive MJ cigarettes contain 0.01% THC | Drug: CBD<br>* Each subject in the study was tested on eight days, each day receiving a different combination of active/inactive cannabis cigarettes plus 0, 200, 400 or 800 mg of CBD in random order. Cigarettes contained either 0.01 or 5.30% THC. At each visit, participants were given four gelatin capsules containing lactose and 0 or 200 mg of CBD in combinations to achieve scheduled dose level.<br>* Other names: cannabidiol is abbreviated CBD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mood Scale - Subscale 'Feeling High' | Participants rated how much they felt having a high feeling from smoked marijuana using a visual analog scale 1-100 mm, 1 (Not at all) - 100 (extremely). | two hours before and after marijuana cigarette smoking | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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reinforcement, good drug effect, high, mood, cannabidiol