Laboratory Study of Cannabidiol on the Effects of Smoked Marijuana

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

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.

Study Overview

• Status: Completed
• Conditions: Smoking, Marijuana
• Intervention / Treatment: Drug: CBD

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40513
      • University of Kentucky, Straus Behavioral Research Bldg., 515 Oldham Ct.
  • New York
    • New York, New York, United States, 10032
      • Marijuana Outpatient Lab 1051 Riverside Dr. Unit #120
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Center for Drug and Alcohol Programs, Room 459 North, 67 President St.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Active marijuana (MJ) with 0 mg CBD; Active MJ cigarettes contain 5.30% THC	Drug: CBD; 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.; Other Names: cannabidiol is abbreviated CBD
Other: Active MJ with 200 mg CBD; Active MJ cigarettes contain 5.30% THC	Drug: CBD; 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.; Other Names: cannabidiol is abbreviated CBD
Other: Active MJ with 400 mg CBD; Active MJ cigarettes contain 5.30% THC	Drug: CBD; 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.; Other Names: cannabidiol is abbreviated CBD
Other: Active MJ with 800 mg CBD; Active MJ cigarettes contain 5.30% THC	Drug: CBD; 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.; Other Names: cannabidiol is abbreviated CBD
Other: Inactive MJ with 0 mg CBD; Inactive MJ cigarettes contain 0.01% THC	Drug: CBD; 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.; Other Names: cannabidiol is abbreviated CBD
Other: Inactive MJ with 200 mg CBD; Inactive MJ cigarettes contain 0.01% THC	Drug: CBD; 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.; Other Names: cannabidiol is abbreviated CBD
Other: Inactive MJ with 400 mg CBD; Inactive MJ cigarettes contain 0.01% THC	Drug: CBD; 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.; Other Names: cannabidiol is abbreviated CBD
Other: Inactive MJ with 800 mg CBD; Inactive MJ cigarettes contain 0.01% THC	Drug: CBD; 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.; Other Names: cannabidiol is abbreviated CBD

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Marijuana Rating Form - Like	Participants rated how much they liked the effects of smoked marijuana using a visual analog scale 1-100 mm, 1=least, 100= most	15 - 120 minutes after marijuana cigarette smoking
Marijuana Rating Form - Strength	Participants rated the strength effects of smoked marijuana using a visual analog scale 1-100 mm, 1=least, 100= most	15 - 120 minutes after marijuana cigarette smoking
Optional Additional Puffs of MJ Cigarette	Participants were allowed to choose to take or reject additional puffs of the same type of MJ cigarette they smoked earlier in the day. Counts of participants choosing to take additional puffs are reported.	150 to 250 minutes after first marijuana cigarette was smoked earlier in the day
Number of Optional Puffs of MJ Cigarette Taken	Mean number of puffs taken by those participants who chose to take additional puffs.	150 to 160 minutes after first marijuana cigarette was smoked earlier in the day
Heart Rate	Heart rate measured at 10 time points, 4 before and 6 after smoking cannabis.	120 minutes before and 150 minutes after marijuana cigarette smoking
Plasma Concentration of CBD	Plasma concentrations of cannabidiol were measured at six time points after oral administration of four 200 mg capsules of CBD.	6 hours

Collaborators and Investigators

• Sponsor: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Margaret Haney, M.D., New York State Psychiatric Institute; Study Director: Robert J Malcolm, M.D., Medical University of South Carolina; Study Director: Sharon Walsh, Ph.D., University of Kentucky

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): October 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: April 29, 2013
• First Submitted That Met QC Criteria: April 29, 2013
• First Posted (Estimate): May 1, 2013

Study Record Updates

• Last Update Posted (Actual): December 9, 2019
• Last Update Submitted That Met QC Criteria: November 21, 2019
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: reinforcement, good drug effect, high, mood, cannabidiol
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Marijuana Abuse; Marijuana Use; Anticonvulsants; Cannabidiol
• Other Study ID Numbers: Study Number CBD-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No