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Laboratory Study of Cannabidiol on the Effects of Smoked Marijuana

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2013 by National Institute on Drug Abuse (NIDA)
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: May 21, 2013
Last verified: May 2013
  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
Smoking, Marijuana
Drug: cannabidiol

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
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 National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • Cognitive Performance Battery [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]
    Cognitive tasks such as the Digit-Symbol Substitution Task, Continuous Performance Task and Digit Span Backwards


Other Outcome Measures:
  • Marijuana Rating Form [ Time Frame: 2 minutes ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Participants rate the capsule strength, capsule liking, desire to take again, good drug effect and bad drug effect.

  • Mood Scale [ Time Frame: 2 minutes ] [ Designated as safety issue: No ]
    Visual analog scale used to assess subjective drug effects including physical symptoms and mood.


Estimated Enrollment: 36
Study Start Date: May 2013
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active or inactive MJ with 0, 200, 400, or 800 mg CBD
Each subject in the study will be tested on eight days, each day receiving a different combination of active/inactive marijuana cigarette plus 0, 200, 400 or 800 mg of cannabidiol
Drug: cannabidiol
Other Name: cannabidiol is abbreviated CBD

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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. Recruiting
Lexington, Kentucky, United States, 40513
Contact: Michelle Wolf    859-257-1612      
Principal Investigator: Sharon Walsh, Ph.D.         
United States, New York
Marijuana Outpatient Lab 1051 Riverside Dr. Unit #120 Recruiting
New York, New York, United States, 10032
Contact: Bennett Wechsler, B.S.    212-543-5175    wechsle@nyspi.columbia.edu   
Principal Investigator: Margaret Haney, M.D.         
United States, South Carolina
Center for Drug and Alcohol Programs, Room 459 North, 67 President St. Recruiting
Charleston, South Carolina, United States, 29425
Contact: Kristi Huebner, BS RN MPH    843-792-1901    huebnerk@musc.edu   
Contact: Kim Irk, B.S.    843-792-1231.    irkki@musc.edu   
Principal Investigator: Robert Malcolm, M.D.         
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

No publications provided

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
Last Updated: May 21, 2013
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on November 25, 2014