Phase 2
N=50
Laboratory Study of Cannabidiol on the Effects of Smoked Marijuana
Smoking, Marijuana
Bottom Line
View on ClinicalTrials.gov: NCT01844687 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Apr 2017
Primary outcome: Primary: Mood Scale - Subscale 'Feeling High' — 4.35; 2.48; 0.39; 6.55 units on a scale VAS 1-100 mm
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CBD (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Institute on Drug Abuse (NIDA)
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mood Scale - Subscale 'Feeling High' |
4.35; 2.48; 0.39; 6.55; 0.42; 0.32 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01844687). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.