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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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.
There has been a rapid increase in marijuana use during the 1990s, with the most recent generation often smoking marijuana in the form of 'blunts' as opposed to more traditional routes such as in pipes or in cigarette paper. A blunt is made by removing the tobacco from a cigar and replacing it with marijuana (Golub and Johnson, 1999). The cigar wrapper contains tobacco and nicotine, which may interact with the cardiovascular and subjective effects of the marijuana to produce a different set of effects and risks than cigarette paper. Anecdotally, marijuana smokers report that blunts are more potent than joints, yet there have been no controlled studies addressing whether blunts enhance the subjective-effects and health-related consequences of marijuana use. We are proposing to do a within-subject, placebo-controlled study directly comparing the cardiovascular, subjective and pharmacokinetic effects of marijuana smoked in blunts compared to identical quantities of marijuana smoked in cigarette paper. Research volunteers will be current blunt smokers. Each will participate in six, 4-hour outpatient sessions. After baseline data have been collected (heart rate, blood pressure, mood scales, exhaled carbon monoxide, plasma THC and nicotine levels), participants will take 3 puffs, 5 seconds in duration, from a NIDA marijuana cigarette containing 0.0, 1.8 and 3.6% THC or from a blunt containing an equivalent quantity and strength of marijuana. Participants will be blind to the type of marijuana cigarette smoked. We will measure plasma THC and nicotine, subjective mood ratings, and heart rate and blood pressure repeatedly over the course of 180 minutes following smoking. This study is the first controlled investigation of the consequences of this new method of marijuana smoking; the data obtained may be useful in guiding future development of marijuana pharmacotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| marijuana blunt | Experimental | marijuana blunt (0%, 1.8%, or 3.6% THC) |
|
| marijuana cigarette | Experimental | marijuana cigarette (0%, 1.8%, or 3.6% THC) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Marijuana blunt | Drug | Blunts were fabricated by cutting the bottom third off a Dutch Master® cigar, removing all of the cigar tobacco, and replacing it with all of the marijuana contained in a NIDA marijuana cigarette (ca. 800 mg). |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma THC | Plasma THC levels were analyzed to determine pharmacokinetic differences between marijuana cigarettes vs marijuana blunts. | 180 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective Effects on MRF | 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. | 180 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margaret Haney, Ph.D. | New York State Psychiatric Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York State Psychiatric Institute | New York | New York | 10032 | United States |
Prior to enrollment, participants gave written informed consent, received a psychiatric and medical evaluation, and provided a detailed drug use and medical history.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Marijuana | marijuana blunt (0%, 1.8%, or 3.6% THC) vs. marijuana cigarette (0%, 1.8%, or 3.6% THC) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Marijuana | marijuana blunt (0%, 1.8%, or 3.6% THC) vs. marijuana cigarette (0%, 1.8%, or 3.6% THC) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Plasma THC | Plasma THC levels were analyzed to determine pharmacokinetic differences between marijuana cigarettes vs marijuana blunts. | Twenty four participants were included in this within-subjects analysis. | Posted | Mean | Standard Deviation | ng/mL | 180 minutes |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Marijuana Blunt | marijuana blunt (0%, 1.8%, or 3.6% THC) Marijuana blunt | 0 |
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It is unknown if the cigar paper would provide physiologically relevant nicotine plasma levels under more extended durations of smoking. The small sample size prohibited an analysis to verify a statistically significant sex difference.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Meg Haney, Professor of Neurobiology | New York State Psychiatric Institute at Columbia University Medical Center | 6467746153 | meg.haney@nyspi.columbia.edu |
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| ID | Term |
|---|---|
| D002189 | Marijuana Abuse |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| marijuana cigarette | Drug | Marijuana cigarettes were provided by the National Institute on Drug Abuse. |
|
|
| Subjective Effects on VAS | 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 | 180 minutes |
| Carbon Monoxide | Expired carbon monoxide averaged across all post-smoking time points when marijuana was smoked as joints and blunts for all participants. | 180 minutes |
| Heart Rate | Heart rate averaged across all post-smoking time points when marijuana was smoked as joints and blunts. | 180 minutes |
| Pregnancy |
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| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 |
| Marijuana Blunt 3.6% THC |
One of six within-subjects conditions where patients received a marijuana blunt containing 3.6% THC. |
| OG003 | Marijuana Cigarette 0% THC | One of six within-subjects conditions where patients received a marijuana cigarette containing 0% THC. |
| OG004 | Marijuana Cigarette 1.8% THC | One of six within-subjects conditions where patients received a marijuana cigarette containing 1.8% THC. |
| OG005 | Marijuana Cigarette 3.6% THC | One of six within-subjects conditions where patients received a marijuana cigarette containing 3.6% THC. |
|
|
| Secondary | Subjective Effects on MRF | 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. | Twenty four participants were included in this within-subjects analysis. | Posted | Mean | Standard Deviation | Ratings (mm) | 180 minutes |
|
|
|
| Secondary | Subjective Effects on VAS | 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 | Twenty-four participants were included in this analysis. | Posted | Mean | Standard Deviation | Ratings (mm) | 180 minutes |
|
|
|
| Secondary | Carbon Monoxide | Expired carbon monoxide averaged across all post-smoking time points when marijuana was smoked as joints and blunts for all participants. | Twenty-four participants were included in this analysis. | Posted | Mean | Standard Deviation | ppm | 180 minutes |
|
|
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| Secondary | Heart Rate | Heart rate averaged across all post-smoking time points when marijuana was smoked as joints and blunts. | Twenty-four participants were included in this analysis. | Posted | Mean | Standard Deviation | BPM | 180 minutes |
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| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Marijuana Cigarette | marijuana cigarette (0%, 1.8%, or 3.6% THC) marijuana cigarette | 0 | 24 | 0 | 24 | 0 | 24 |
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| "Liking" |
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| "Strong" |
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| High |
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