Phase 2
N=35
Comparison Between Marijuana Smoked in Cigarette Paper Versus Cigar Paper
Marijuana Dependence
Bottom Line
View on ClinicalTrials.gov: NCT00374127 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcome: Primary: Plasma THC — 6; 53; 70; 7 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Marijuana blunt (Drug); marijuana cigarette (Drug)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- New York State Psychiatric Institute
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plasma THC |
6; 53; 70; 7; 80; 98 | — |
| SECONDARY Subjective Effects on MRF |
23; 28; 36; 12; 45; 54 | — |
| SECONDARY Subjective Effects on VAS |
10; 29; 33; 4; 28; 37 | — |
| SECONDARY Carbon Monoxide |
5.9; 6.4; 5.8; 5.5; 5.9; 5.3 | — |
| SECONDARY Heart Rate |
70.5; 72.5; 73; 70.5; 72; 74 | — |
Summary
The purpose of this study is to investigate whether or not marijuana blunts will produce comparable plasma THC levels as marijuana joints and if blunts will produce larger cardiovascular and subjective effects.
Eligibility Criteria
Inclusion Criteria
- Current blunt marijuana use (minimum of twice/week) drug screen
- 21-45 years of age
- Practicing an effective form of birth control (condoms, diaphragm, birth control pill, IUD)
Exclusion Criteria
- Current, repeated illicit drug use(excluding marijuana)
- Heavy cigarette use (> 10 cigarettes/day)
- Presence of significant medical illness (e.g., diabetes, cardiovascular disease, hypertension)
- Laboratory tests outside normal limits that are clinically unacceptable to the study physician (BP > 140/90; hematocrit < 34 for women, < 36 for men)
- Significant adverse reaction to marijuana
- Current parole or probation
- Pregnancy or current lactation
- History of significant violent behavior
- Major current Axis I psychopathology(e.g., mood disorder with functional impairment or suicide risk, anxiety disorder, schizophrenia)
- History of heart disease
- Current use of any over-the-counter or prescription
Data sourced from ClinicalTrials.gov (NCT00374127). 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.