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Laboratory Study of Cannabidiol on the Effects of Smoked Marijuana

Primary Purpose

Smoking, Marijuana

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CBD
Sponsored by
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Smoking, Marijuana focused on measuring reinforcement, good drug effect, high, mood, cannabidiol

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Kentucky, Straus Behavioral Research Bldg., 515 Oldham Ct.
  • Marijuana Outpatient Lab 1051 Riverside Dr. Unit #120
  • Center for Drug and Alcohol Programs, Room 459 North, 67 President St.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Other

Other

Other

Other

Other

Other

Other

Other

Arm Label

Active marijuana (MJ) with 0 mg CBD

Active MJ with 200 mg CBD

Active MJ with 400 mg CBD

Active MJ with 800 mg CBD

Inactive MJ with 0 mg CBD

Inactive MJ with 200 mg CBD

Inactive MJ with 400 mg CBD

Inactive MJ with 800 mg CBD

Arm Description

Active MJ cigarettes contain 5.30% THC

Active MJ cigarettes contain 5.30% THC

Active MJ cigarettes contain 5.30% THC

Active MJ cigarettes contain 5.30% THC

Inactive MJ cigarettes contain 0.01% THC

Inactive MJ cigarettes contain 0.01% THC

Inactive MJ cigarettes contain 0.01% THC

Inactive MJ cigarettes contain 0.01% THC

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
April 29, 2013
Last Updated
November 21, 2019
Sponsor
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01844687
Brief Title
Laboratory Study of Cannabidiol on the Effects of Smoked Marijuana
Official Title
Laboratory Study of the Influence of Oral Cannabidiol on the Subjective, Reinforcing and Cardiovascular Effects of Smoked Marijuana
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking, Marijuana
Keywords
reinforcement, good drug effect, high, mood, cannabidiol

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active marijuana (MJ) with 0 mg CBD
Arm Type
Other
Arm Description
Active MJ cigarettes contain 5.30% THC
Arm Title
Active MJ with 200 mg CBD
Arm Type
Other
Arm Description
Active MJ cigarettes contain 5.30% THC
Arm Title
Active MJ with 400 mg CBD
Arm Type
Other
Arm Description
Active MJ cigarettes contain 5.30% THC
Arm Title
Active MJ with 800 mg CBD
Arm Type
Other
Arm Description
Active MJ cigarettes contain 5.30% THC
Arm Title
Inactive MJ with 0 mg CBD
Arm Type
Other
Arm Description
Inactive MJ cigarettes contain 0.01% THC
Arm Title
Inactive MJ with 200 mg CBD
Arm Type
Other
Arm Description
Inactive MJ cigarettes contain 0.01% THC
Arm Title
Inactive MJ with 400 mg CBD
Arm Type
Other
Arm Description
Inactive MJ cigarettes contain 0.01% THC
Arm Title
Inactive MJ with 800 mg CBD
Arm Type
Other
Arm Description
Inactive MJ cigarettes contain 0.01% THC
Intervention Type
Drug
Intervention Name(s)
CBD
Other Intervention Name(s)
cannabidiol is abbreviated CBD
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mood Scale - Subscale 'Feeling High'
Description
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).
Time Frame
two hours before and after marijuana cigarette smoking
Other Pre-specified Outcome Measures:
Title
Marijuana Rating Form - Like
Description
Participants rated how much they liked the effects of smoked marijuana using a visual analog scale 1-100 mm, 1=least, 100= most
Time Frame
15 - 120 minutes after marijuana cigarette smoking
Title
Marijuana Rating Form - Strength
Description
Participants rated the strength effects of smoked marijuana using a visual analog scale 1-100 mm, 1=least, 100= most
Time Frame
15 - 120 minutes after marijuana cigarette smoking
Title
Optional Additional Puffs of MJ Cigarette
Description
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.
Time Frame
150 to 250 minutes after first marijuana cigarette was smoked earlier in the day
Title
Number of Optional Puffs of MJ Cigarette Taken
Description
Mean number of puffs taken by those participants who chose to take additional puffs.
Time Frame
150 to 160 minutes after first marijuana cigarette was smoked earlier in the day
Title
Heart Rate
Description
Heart rate measured at 10 time points, 4 before and 6 after smoking cannabis.
Time Frame
120 minutes before and 150 minutes after marijuana cigarette smoking
Title
Plasma Concentration of CBD
Description
Plasma concentrations of cannabidiol were measured at six time points after oral administration of four 200 mg capsules of CBD.
Time Frame
6 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret Haney, M.D.
Organizational Affiliation
New York State Psychiatric Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert J Malcolm, M.D.
Organizational Affiliation
Medical University of South Carolina
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sharon Walsh, Ph.D.
Organizational Affiliation
University of Kentucky
Official's Role
Study Director
Facility Information:
Facility Name
University of Kentucky, Straus Behavioral Research Bldg., 515 Oldham Ct.
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40513
Country
United States
Facility Name
Marijuana Outpatient Lab 1051 Riverside Dr. Unit #120
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Center for Drug and Alcohol Programs, Room 459 North, 67 President St.
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Laboratory Study of Cannabidiol on the Effects of Smoked Marijuana

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