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NCT Number: NCT01844687

Laboratory Study of Cannabidiol on the Effects of Smoked Marijuana

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.

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Key information

Conditions

Smoking, Marijuana Behavior Marijuana Smoking Marijuana Use Smoking Smoking, Non-Tobacco Products

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CBD

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.

Other names: cannabidiol is abbreviated CBD

Primary outcomes

  1. Mood Scale - Subscale 'Feeling High'

    Time frame: 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).

Other outcomes

  1. Marijuana Rating Form - Like

    Time frame: 15 - 120 minutes after marijuana cigarette smoking

    Participants rated how much they liked the effects of smoked marijuana using a visual analog scale 1-100 mm, 1=least, 100= most

  2. Marijuana Rating Form - Strength

    Time frame: 15 - 120 minutes after marijuana cigarette smoking

    Participants rated the strength effects of smoked marijuana using a visual analog scale 1-100 mm, 1=least, 100= most

  3. Optional Additional Puffs of MJ Cigarette

    Time frame: 150 to 250 minutes after first marijuana cigarette was smoked earlier in the day

    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.

  4. Number of Optional Puffs of MJ Cigarette Taken

    Time frame: 150 to 160 minutes after first marijuana cigarette was smoked earlier in the day

    Mean number of puffs taken by those participants who chose to take additional puffs.

  5. Heart Rate

    Time frame: 120 minutes before and 150 minutes after marijuana cigarette smoking

    Heart rate measured at 10 time points, 4 before and 6 after smoking cannabis.

  6. Plasma Concentration of CBD

    Time frame: 6 hours

    Plasma concentrations of cannabidiol were measured at six time points after oral administration of four 200 mg capsules of CBD.

Sponsors and collaborators

Lead sponsor

National Institute on Drug Abuse (NIDA)

Nih

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 1, 2013
Registry last updated
Dec 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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