Clinical trial NCT01844687: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Smoking, Marijuana
Keywords: reinforcement, good drug effect, high, mood, cannabidiol
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2013-05-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Mood Scale - Subscale 'Feeling High'
timeFrame: two hours before and after marijuana cigarette smoking
Secondary outcomes:
Other outcomes:
measure: Marijuana Rating Form - Like
timeFrame: 15 - 120 minutes after marijuana cigarette smoking
measure: Marijuana Rating Form - Strength
timeFrame: 15 - 120 minutes after marijuana cigarette smoking
measure: Optional Additional Puffs of MJ Cigarette
timeFrame: 150 to 250 minutes after first marijuana cigarette was smoked earlier in the day
measure: Number of Optional Puffs of MJ Cigarette Taken
timeFrame: 150 to 160 minutes after first marijuana cigarette was smoked earlier in the day
measure: Heart Rate
timeFrame: 120 minutes before and 150 minutes after marijuana cigarette smoking
measure: Plasma Concentration of CBD
timeFrame: 6 hours
Locations:
city: Lexington
country: United States
facility: University of Kentucky, Straus Behavioral Research Bldg., 515 Oldham Ct.
state: Kentucky
city: New York
country: United States
facility: Marijuana Outpatient Lab 1051 Riverside Dr. Unit #120
state: New York
city: Charleston
country: United States
facility: Center for Drug and Alcohol Programs, Room 459 North, 67 President St.
state: South Carolina
Study officials:
affiliation: New York State Psychiatric Institute
name: Margaret Haney, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of South Carolina
name: Robert J Malcolm, M.D.
role: STUDY_DIRECTOR
affiliation: University of Kentucky
name: Sharon Walsh, Ph.D.
role: STUDY_DIRECTOR
References: