Laboratory Study of Cannabidiol on the Effects of Smoked Marijuana

Smoking, Marijuana Clinical Trial

Official title:

Laboratory Study of the Influence of Oral Cannabidiol on the Subjective, Reinforcing and Cardiovascular Effects of Smoked Marijuana

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01844687
• Other study ID #: Study Number CBD-001
• Status: Completed
• Phase: Phase 2
• Start date: May 2013
• Est. completion date: October 2014

Study information

• Verified date: April 2017
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Marijuana Abuse
• Marijuana Use
• Smoking, Marijuana

Intervention

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.

Locations

Country	Name	City	State
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	Marijuana Outpatient Lab 1051 Riverside Dr. Unit #120	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Marijuana Rating Form - Like	Participants rated how much they liked the effects of smoked marijuana using a visual analog scale 1-100 mm, 1=least, 100= most	15 - 120 minutes after marijuana cigarette smoking
Other	Marijuana Rating Form - Strength	Participants rated the strength effects of smoked marijuana using a visual analog scale 1-100 mm, 1=least, 100= most	15 - 120 minutes after marijuana cigarette smoking
Other	Optional Additional Puffs of MJ Cigarette	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.	150 to 250 minutes after first marijuana cigarette was smoked earlier in the day
Other	Number of Optional Puffs of MJ Cigarette Taken	Mean number of puffs taken by those participants who chose to take additional puffs.	150 to 160 minutes after first marijuana cigarette was smoked earlier in the day
Other	Heart Rate	Heart rate measured at 10 time points, 4 before and 6 after smoking cannabis.	120 minutes before and 150 minutes after marijuana cigarette smoking
Other	Plasma Concentration of CBD	Plasma concentrations of cannabidiol were measured at six time points after oral administration of four 200 mg capsules of CBD.	6 hours
Primary	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).	two hours before and after marijuana cigarette smoking