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Laboratory Study of Cannabidiol on the Effects of Smoked Marijuana

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Steve Sparenborg, National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT01844687
First received: April 29, 2013
Last updated: April 5, 2017
Last verified: April 2017
  Purpose
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 Intervention Phase
Smoking, Marijuana Drug: CBD Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Steve Sparenborg, National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Mood Scale - Subscale 'Feeling High' [ Time Frame: two hours before and after marijuana cigarette smoking ]
    Visual analog scale range 1 (not at all) - 100 (extremely) millimeters.


Other Outcome Measures:
  • 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

  • Marijuana Rating Form - Strength [ Time Frame: 15 - 120 minutes after marijuana cigarette smoking ]
    Subjects rated how strong the effects of the cannabis were using a visual analog scale.

  • 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.

  • 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.

  • 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.

  • 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.


Enrollment: 50
Study Start Date: May 2013
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01844687

Locations
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
Steve Sparenborg
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
  More Information

Responsible Party: Steve Sparenborg, Pharmacotherapy Clinical Trials Team Leader, National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT01844687     History of Changes
Other Study ID Numbers: Study Number CBD-001
Study First Received: April 29, 2013
Results First Received: January 7, 2017
Last Updated: April 5, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Steve Sparenborg, National Institute on Drug Abuse (NIDA):
reinforcement, good drug effect, high, mood, cannabidiol

Additional relevant MeSH terms:
Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 21, 2017