Laboratory Study of Cannabidiol on the Effects of Smoked Marijuana

Phase 2

Completed

• Conditions: Smoking, Marijuana
• Interventions: Drug: CBD

• Registration Number: NCT01844687
• Lead Sponsor: National Institute on Drug Abuse (NIDA)

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 Timeline

• Study First Submitted: 2013-04-29
• Study First Submitted QC: 2013-04-29
• Study Start: 2013-05
• Study First Posted: 2013-05-01
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Results First Submitted: 2017-01-07
• Status Verified: 2017-04
• Results First Submitted QC: 2017-04-05
• Results First Posted: 2017-04-25
• Last Update Submitted: 2019-11-21
• Last Update Posted: 2019-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active marijuana (MJ) with 0 mg CBD	CBD	Active MJ cigarettes contain 5.30% THC
Active MJ with 200 mg CBD	CBD	Active MJ cigarettes contain 5.30% THC
Active MJ with 400 mg CBD	CBD	Active MJ cigarettes contain 5.30% THC
Inactive MJ with 0 mg CBD	CBD	Inactive MJ cigarettes contain 0.01% THC
Active MJ with 800 mg CBD	CBD	Active MJ cigarettes contain 5.30% THC
Inactive MJ with 200 mg CBD	CBD	Inactive MJ cigarettes contain 0.01% THC
Inactive MJ with 800 mg CBD	CBD	Inactive MJ cigarettes contain 0.01% THC
Inactive MJ with 400 mg CBD	CBD	Inactive MJ cigarettes contain 0.01% THC

Primary Outcome Measures

Name	Time	Method
Mood Scale - Subscale 'Feeling High'	two hours before and after marijuana cigarette smoking	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).

Trial Locations

Locations (3)

Marijuana Outpatient Lab 1051 Riverside Dr. Unit #120; 🇺🇸 New York, New York, United States

Center for Drug and Alcohol Programs, Room 459 North, 67 President St.; 🇺🇸 Charleston, South Carolina, United States

University of Kentucky, Straus Behavioral Research Bldg., 515 Oldham Ct.; 🇺🇸 Lexington, Kentucky, United States