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Laboratory Study of Cannabidiol on the Effects of Smoked Marijuana

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01844687
Recruitment Status : Completed
First Posted : May 1, 2013
Results First Posted : April 25, 2017
Last Update Posted : December 9, 2019
Sponsor:
Information provided by (Responsible Party):
National Institute on Drug Abuse (NIDA)

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Smoking, Marijuana Drug: CBD Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Laboratory Study of the Influence of Oral Cannabidiol on the Subjective, Reinforcing and Cardiovascular Effects of Smoked Marijuana
Study Start Date : May 2013
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana
Drug Information available for: Cannabidiol

Arms and Interventions
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Arm Intervention/treatment
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 Name: cannabidiol is abbreviated CBD
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 Name: cannabidiol is abbreviated CBD
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 Name: cannabidiol is abbreviated CBD
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 Name: cannabidiol is abbreviated CBD
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 Name: cannabidiol is abbreviated CBD
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 Name: cannabidiol is abbreviated CBD
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 Name: cannabidiol is abbreviated CBD
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 Name: cannabidiol is abbreviated CBD


Outcome Measures
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Primary Outcome Measures :
  1. Mood Scale - Subscale 'Feeling High' [ Time Frame: two hours before and after marijuana cigarette smoking ]
    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).


Other Outcome Measures:
  1. Marijuana Rating Form - Like [ Time Frame: 15 - 120 minutes after marijuana cigarette smoking ]
    Participants rated how much they liked the effects of smoked marijuana using a visual analog scale 1-100 mm, 1=least, 100= most

  2. Marijuana Rating Form - Strength [ Time Frame: 15 - 120 minutes after marijuana cigarette smoking ]
    Participants rated the strength effects of smoked marijuana using a visual analog scale 1-100 mm, 1=least, 100= most

  3. Optional Additional Puffs of MJ Cigarette [ Time Frame: 150 to 250 minutes after first marijuana cigarette was smoked earlier in the day ]
    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.

  4. Number of Optional Puffs of MJ Cigarette Taken [ Time Frame: 150 to 160 minutes after first marijuana cigarette was smoked earlier in the day ]
    Mean number of puffs taken by those participants who chose to take additional puffs.

  5. Heart Rate [ Time Frame: 120 minutes before and 150 minutes after marijuana cigarette smoking ]
    Heart rate measured at 10 time points, 4 before and 6 after smoking cannabis.

  6. Plasma Concentration of CBD [ Time Frame: 6 hours ]
    Plasma concentrations of cannabidiol were measured at six time points after oral administration of four 200 mg capsules of CBD.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01844687


Locations
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United States, Kentucky
University of Kentucky, Straus Behavioral Research Bldg., 515 Oldham Ct.
Lexington, Kentucky, United States, 40513
United States, New York
Marijuana Outpatient Lab 1051 Riverside Dr. Unit #120
New York, New York, United States, 10032
United States, South Carolina
Center for Drug and Alcohol Programs, Room 459 North, 67 President St.
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
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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
More Information
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Responsible Party: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT01844687    
Other Study ID Numbers: Study Number CBD-001
First Posted: May 1, 2013    Key Record Dates
Results First Posted: April 25, 2017
Last Update Posted: December 9, 2019
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by National Institute on Drug Abuse (NIDA):
reinforcement, good drug effect, high, mood, cannabidiol
Additional relevant MeSH terms:
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Marijuana Abuse
Marijuana Use
Substance-Related Disorders
Chemically-Induced Disorders
 Mental Disorders
Cannabidiol
Anticonvulsants