Trial Outcomes & Findings for Comparison Between Marijuana Smoked in Cigarette Paper Versus Cigar Paper (NCT NCT00374127)
NCT ID: NCT00374127
Last Updated: 2017-09-01
Results Overview
Plasma THC levels were analyzed to determine pharmacokinetic differences between marijuana cigarettes vs marijuana blunts.
COMPLETED
PHASE2
35 participants
180 minutes
2017-09-01
Participant Flow
Normal, healthy volunteers ages 21-45 were recruited through newspaper advertisements and those who met inclusion/exclusion criteria after an initial phone screen were invited to the laboratory for further screening.
Prior to enrollment, participants gave written informed consent, received a psychiatric and medical evaluation, and provided a detailed drug use and medical history.
Participant milestones
| Measure |
Marijuana
marijuana blunt (0%, 1.8%, or 3.6% THC) vs. marijuana cigarette (0%, 1.8%, or 3.6% THC)
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Marijuana
marijuana blunt (0%, 1.8%, or 3.6% THC) vs. marijuana cigarette (0%, 1.8%, or 3.6% THC)
|
|---|---|
|
Overall Study
Did not inhale during smoking procedure.
|
3
|
|
Overall Study
Blood could not be drawn.
|
2
|
|
Overall Study
Protocol Violation
|
5
|
|
Overall Study
Pregnancy
|
1
|
Baseline Characteristics
Comparison Between Marijuana Smoked in Cigarette Paper Versus Cigar Paper
Baseline characteristics by cohort
| Measure |
Marijuana
n=24 Participants
marijuana blunt (0%, 1.8%, or 3.6% THC) vs. marijuana cigarette (0%, 1.8%, or 3.6% THC)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
24 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
25.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 180 minutesPopulation: Twenty four participants were included in this within-subjects analysis.
Plasma THC levels were analyzed to determine pharmacokinetic differences between marijuana cigarettes vs marijuana blunts.
Outcome measures
| Measure |
Marijuana Blunt 0% THC
n=24 Participants
One of six within-subjects conditions where patients received a marijuana blunt containing 0% THC.
|
Marijuana Blunt 1.8% THC
n=24 Participants
One of six within-subjects conditions where patients received a marijuana blunt containing 1.8% THC.
|
Marijuana Blunt 3.6% THC
n=24 Participants
One of six within-subjects conditions where patients received a marijuana blunt containing 3.6% THC.
|
Marijuana Cigarette 0% THC
n=24 Participants
One of six within-subjects conditions where patients received a marijuana cigarette containing 0% THC.
|
Marijuana Cigarette 1.8% THC
n=24 Participants
One of six within-subjects conditions where patients received a marijuana cigarette containing 1.8% THC.
|
Marijuana Cigarette 3.6% THC
n=24 Participants
One of six within-subjects conditions where patients received a marijuana cigarette containing 3.6% THC.
|
|---|---|---|---|---|---|---|
|
Plasma THC
|
6 ng/mL
Standard Deviation 1
|
53 ng/mL
Standard Deviation 2
|
70 ng/mL
Standard Deviation 2
|
7 ng/mL
Standard Deviation 1
|
80 ng/mL
Standard Deviation 3
|
98 ng/mL
Standard Deviation 3
|
SECONDARY outcome
Timeframe: 180 minutesPopulation: Twenty four participants were included in this within-subjects analysis.
Using the Marijuana Rating Form (MRF), subjective effects of "Take Again", "Liking", and "Strong" were assessed. The MRF is a visual analog scale allowing patients to indicate how they feel on a 100-mm line anchored with 'not at all' at the left end and 'extremely' at the right end, when prompted by a statement.
Outcome measures
| Measure |
Marijuana Blunt 0% THC
n=24 Participants
One of six within-subjects conditions where patients received a marijuana blunt containing 0% THC.
|
Marijuana Blunt 1.8% THC
n=24 Participants
One of six within-subjects conditions where patients received a marijuana blunt containing 1.8% THC.
|
Marijuana Blunt 3.6% THC
n=24 Participants
One of six within-subjects conditions where patients received a marijuana blunt containing 3.6% THC.
|
Marijuana Cigarette 0% THC
n=24 Participants
One of six within-subjects conditions where patients received a marijuana cigarette containing 0% THC.
|
Marijuana Cigarette 1.8% THC
n=24 Participants
One of six within-subjects conditions where patients received a marijuana cigarette containing 1.8% THC.
|
Marijuana Cigarette 3.6% THC
n=24 Participants
One of six within-subjects conditions where patients received a marijuana cigarette containing 3.6% THC.
|
|---|---|---|---|---|---|---|
|
Subjective Effects on MRF
"Take Again"
|
23 Ratings (mm)
Standard Deviation 0.5
|
28 Ratings (mm)
Standard Deviation 0.4
|
36 Ratings (mm)
Standard Deviation 0.5
|
12 Ratings (mm)
Standard Deviation 0.4
|
45 Ratings (mm)
Standard Deviation 0.5
|
54 Ratings (mm)
Standard Deviation 0.4
|
|
Subjective Effects on MRF
"Liking"
|
18 Ratings (mm)
Standard Deviation 0.4
|
30 Ratings (mm)
Standard Deviation 0.5
|
33 Ratings (mm)
Standard Deviation 0.4
|
10 Ratings (mm)
Standard Deviation 0.5
|
45 Ratings (mm)
Standard Deviation 0.4
|
55 Ratings (mm)
Standard Deviation 0.5
|
|
Subjective Effects on MRF
"Strong"
|
10 Ratings (mm)
Standard Deviation 0.5
|
17 Ratings (mm)
Standard Deviation 0.4
|
29 Ratings (mm)
Standard Deviation 0.5
|
5 Ratings (mm)
Standard Deviation 0.4
|
30 Ratings (mm)
Standard Deviation 0.5
|
42 Ratings (mm)
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: 180 minutesPopulation: Twenty-four participants were included in this analysis.
Subjective VAS ratings of 'Good Drug Effect' and 'High' averaged across all post-smoking time points when marijuana was smoked as joints and blunts analyzed for all participants. Here, participants indicated how they were feeling on a 100-mm line anchored with 'not at all' at the left end and 'extremely' at the right end, when prompted by a statement
Outcome measures
| Measure |
Marijuana Blunt 0% THC
n=24 Participants
One of six within-subjects conditions where patients received a marijuana blunt containing 0% THC.
|
Marijuana Blunt 1.8% THC
n=24 Participants
One of six within-subjects conditions where patients received a marijuana blunt containing 1.8% THC.
|
Marijuana Blunt 3.6% THC
n=24 Participants
One of six within-subjects conditions where patients received a marijuana blunt containing 3.6% THC.
|
Marijuana Cigarette 0% THC
n=24 Participants
One of six within-subjects conditions where patients received a marijuana cigarette containing 0% THC.
|
Marijuana Cigarette 1.8% THC
n=24 Participants
One of six within-subjects conditions where patients received a marijuana cigarette containing 1.8% THC.
|
Marijuana Cigarette 3.6% THC
n=24 Participants
One of six within-subjects conditions where patients received a marijuana cigarette containing 3.6% THC.
|
|---|---|---|---|---|---|---|
|
Subjective Effects on VAS
High
|
7 Ratings (mm)
Standard Deviation 0.4
|
10 Ratings (mm)
Standard Deviation 0.5
|
20 Ratings (mm)
Standard Deviation 0.4
|
3 Ratings (mm)
Standard Deviation 0.5
|
23 Ratings (mm)
Standard Deviation 0.4
|
30 Ratings (mm)
Standard Deviation 0.5
|
|
Subjective Effects on VAS
Good Drug Effect
|
10 Ratings (mm)
Standard Deviation 0.5
|
29 Ratings (mm)
Standard Deviation 0.4
|
33 Ratings (mm)
Standard Deviation 0.5
|
4 Ratings (mm)
Standard Deviation 0.4
|
28 Ratings (mm)
Standard Deviation 0.5
|
37 Ratings (mm)
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: 180 minutesPopulation: Twenty-four participants were included in this analysis.
Expired carbon monoxide averaged across all post-smoking time points when marijuana was smoked as joints and blunts for all participants.
Outcome measures
| Measure |
Marijuana Blunt 0% THC
n=24 Participants
One of six within-subjects conditions where patients received a marijuana blunt containing 0% THC.
|
Marijuana Blunt 1.8% THC
n=24 Participants
One of six within-subjects conditions where patients received a marijuana blunt containing 1.8% THC.
|
Marijuana Blunt 3.6% THC
n=24 Participants
One of six within-subjects conditions where patients received a marijuana blunt containing 3.6% THC.
|
Marijuana Cigarette 0% THC
n=24 Participants
One of six within-subjects conditions where patients received a marijuana cigarette containing 0% THC.
|
Marijuana Cigarette 1.8% THC
n=24 Participants
One of six within-subjects conditions where patients received a marijuana cigarette containing 1.8% THC.
|
Marijuana Cigarette 3.6% THC
n=24 Participants
One of six within-subjects conditions where patients received a marijuana cigarette containing 3.6% THC.
|
|---|---|---|---|---|---|---|
|
Carbon Monoxide
|
5.9 ppm
Standard Deviation 0.5
|
6.4 ppm
Standard Deviation 0.4
|
5.8 ppm
Standard Deviation 0.5
|
5.5 ppm
Standard Deviation 0.4
|
5.9 ppm
Standard Deviation 0.5
|
5.3 ppm
Standard Deviation 0.4
|
SECONDARY outcome
Timeframe: 180 minutesPopulation: Twenty-four participants were included in this analysis.
Heart rate averaged across all post-smoking time points when marijuana was smoked as joints and blunts.
Outcome measures
| Measure |
Marijuana Blunt 0% THC
n=24 Participants
One of six within-subjects conditions where patients received a marijuana blunt containing 0% THC.
|
Marijuana Blunt 1.8% THC
n=24 Participants
One of six within-subjects conditions where patients received a marijuana blunt containing 1.8% THC.
|
Marijuana Blunt 3.6% THC
n=24 Participants
One of six within-subjects conditions where patients received a marijuana blunt containing 3.6% THC.
|
Marijuana Cigarette 0% THC
n=24 Participants
One of six within-subjects conditions where patients received a marijuana cigarette containing 0% THC.
|
Marijuana Cigarette 1.8% THC
n=24 Participants
One of six within-subjects conditions where patients received a marijuana cigarette containing 1.8% THC.
|
Marijuana Cigarette 3.6% THC
n=24 Participants
One of six within-subjects conditions where patients received a marijuana cigarette containing 3.6% THC.
|
|---|---|---|---|---|---|---|
|
Heart Rate
|
70.5 BPM
Standard Deviation 0.5
|
72.5 BPM
Standard Deviation 0.4
|
73 BPM
Standard Deviation 0.5
|
70.5 BPM
Standard Deviation 0.4
|
72 BPM
Standard Deviation 0.5
|
74 BPM
Standard Deviation 0.4
|
Adverse Events
Marijuana Blunt
Marijuana Cigarette
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Meg Haney, Professor of Neurobiology
New York State Psychiatric Institute at Columbia University Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place