Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : April 25, 2017
Sponsor:
Information provided by (Responsible Party):
Steve Sparenborg, National Institute on Drug Abuse (NIDA)

Tracking Information
First Submitted Date  ICMJE April 29, 2013
First Posted Date  ICMJE May 1, 2013
Results First Submitted Date  ICMJE January 7, 2017
Results First Posted Date  ICMJE April 25, 2017
Last Update Posted Date April 25, 2017
Study Start Date  ICMJE May 2013
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 5, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 29, 2013)
Cognitive Performance Battery [ Time Frame: 10 minutes ]
Cognitive tasks such as the Digit-Symbol Substitution Task, Continuous Performance Task and Digit Span Backwards
Change History Complete list of historical versions of study NCT01844687 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: April 5, 2017)
  • 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.
Original Other Pre-specified Outcome Measures
 (submitted: April 29, 2013)
  • Marijuana Rating Form [ Time Frame: 2 minutes ]
    Participants rate the strength, liking, desire to take again, good drug effect and bad drug effect of smoked marijuana.
  • Cannabidiol Capsule Rating Form [ Time Frame: 2 minutes ]
    Participants rate the capsule strength, capsule liking, desire to take again, good drug effect and bad drug effect.
  • Mood Scale [ Time Frame: 2 minutes ]
    Visual analog scale used to assess subjective drug effects including physical symptoms and mood.
 
Descriptive Information
Brief Title  ICMJE Laboratory Study of Cannabidiol on the Effects of Smoked Marijuana
Official Title  ICMJE Laboratory Study of the Influence of Oral Cannabidiol on the Subjective, Reinforcing and Cardiovascular Effects of Smoked Marijuana
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Smoking, Marijuana
Intervention  ICMJE 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
Study Arms  ICMJE
  • Active marijuana (MJ) with 0 mg CBD
    Active MJ cigarettes contain 5.30% THC
    Intervention: Drug: CBD
  • Active MJ with 200 mg CBD
    Active MJ cigarettes contain 5.30% THC
    Intervention: Drug: CBD
  • Active MJ with 400 mg CBD
    Active MJ cigarettes contain 5.30% THC
    Intervention: Drug: CBD
  • Active MJ with 800 mg CBD
    Active MJ cigarettes contain 5.30% THC
    Intervention: Drug: CBD
  • Inactive MJ with 0 mg CBD
    Inactive MJ cigarettes contain 0.01% THC
    Intervention: Drug: CBD
  • Inactive MJ with 200 mg CBD
    Inactive MJ cigarettes contain 0.01% THC
    Intervention: Drug: CBD
  • Inactive MJ with 400 mg CBD
    Inactive MJ cigarettes contain 0.01% THC
    Intervention: Drug: CBD
  • Inactive MJ with 800 mg CBD
    Inactive MJ cigarettes contain 0.01% THC
    Intervention: Drug: CBD
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 5, 2017)
50
Original Estimated Enrollment  ICMJE
 (submitted: April 29, 2013)
36
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01844687
Other Study ID Numbers  ICMJE Study Number CBD-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Steve Sparenborg, National Institute on Drug Abuse (NIDA)
Study Sponsor  ICMJE Steve Sparenborg
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account National Institute on Drug Abuse (NIDA)
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP