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Laboratory Study of Cannabidiol on the Effects of Smoked Marijuana

National Institutes of Health (NIH) logo

National Institutes of Health (NIH)

Status and phase

Completed
Phase 2

Conditions

Smoking, Marijuana

Treatments

Drug: CBD

Study type

Interventional

Funder types

NIH

Identifiers

NCT01844687
Study Number CBD-001

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

All

Ages

18 to 50 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

50 participants in 8 patient groups

Active marijuana (MJ) with 0 mg CBD
Other group
Description:
Active MJ cigarettes contain 5.30% THC
Treatment:
Drug: CBD
Active MJ with 200 mg CBD
Other group
Description:
Active MJ cigarettes contain 5.30% THC
Treatment:
Drug: CBD
Active MJ with 400 mg CBD
Other group
Description:
Active MJ cigarettes contain 5.30% THC
Treatment:
Drug: CBD
Active MJ with 800 mg CBD
Other group
Description:
Active MJ cigarettes contain 5.30% THC
Treatment:
Drug: CBD
Inactive MJ with 0 mg CBD
Other group
Description:
Inactive MJ cigarettes contain 0.01% THC
Treatment:
Drug: CBD
Inactive MJ with 200 mg CBD
Other group
Description:
Inactive MJ cigarettes contain 0.01% THC
Treatment:
Drug: CBD
Inactive MJ with 400 mg CBD
Other group
Description:
Inactive MJ cigarettes contain 0.01% THC
Treatment:
Drug: CBD
Inactive MJ with 800 mg CBD
Other group
Description:
Inactive MJ cigarettes contain 0.01% THC
Treatment:
Drug: CBD

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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