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Laboratory Study of Cannabidiol on the Effects of Smoked Marijuana

NCT ID: NCT01844687

Last Updated: 2019-12-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-10-31

Brief Summary

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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

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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.

Conditions

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Smoking, Marijuana

Keywords

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reinforcement, good drug effect, high, mood, cannabidiol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Active marijuana (MJ) with 0 mg CBD

Active MJ cigarettes contain 5.30% THC

Group Type OTHER

CBD

Intervention Type DRUG

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.

Active MJ with 200 mg CBD

Active MJ cigarettes contain 5.30% THC

Group Type OTHER

CBD

Intervention Type DRUG

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.

Active MJ with 400 mg CBD

Active MJ cigarettes contain 5.30% THC

Group Type OTHER

CBD

Intervention Type DRUG

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.

Active MJ with 800 mg CBD

Active MJ cigarettes contain 5.30% THC

Group Type OTHER

CBD

Intervention Type DRUG

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.

Inactive MJ with 0 mg CBD

Inactive MJ cigarettes contain 0.01% THC

Group Type OTHER

CBD

Intervention Type DRUG

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.

Inactive MJ with 200 mg CBD

Inactive MJ cigarettes contain 0.01% THC

Group Type OTHER

CBD

Intervention Type DRUG

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.

Inactive MJ with 400 mg CBD

Inactive MJ cigarettes contain 0.01% THC

Group Type OTHER

CBD

Intervention Type DRUG

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.

Inactive MJ with 800 mg CBD

Inactive MJ cigarettes contain 0.01% THC

Group Type OTHER

CBD

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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cannabidiol is abbreviated CBD

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Margaret Haney, M.D.

Role: PRINCIPAL_INVESTIGATOR

New York State Psychiatric Institute

Robert J Malcolm, M.D.

Role: STUDY_DIRECTOR

Medical University of South Carolina

Sharon Walsh, Ph.D.

Role: STUDY_DIRECTOR

University of Kentucky

Locations

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University of Kentucky, Straus Behavioral Research Bldg., 515 Oldham Ct.

Lexington, Kentucky, United States

Site Status

Marijuana Outpatient Lab 1051 Riverside Dr. Unit #120

New York, New York, United States

Site Status

Center for Drug and Alcohol Programs, Room 459 North, 67 President St.

Charleston, South Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Study Number CBD-001

Identifier Type: -

Identifier Source: org_study_id