Marijuana DependencePhase 2NCT00374127
Comparison Between Marijuana Smoked in Cigarette Paper Versus Cigar Paper
A Phase 2 study testing Marijuana blunt and marijuana cigarette in people with Marijuana Dependence, run by New York State Psychiatric Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Marijuana Dependence
- What is being tested?
- Marijuana blunt and marijuana cigarette
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to Aug 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: Comparison Between Marijuana Smoked in Cigarette Paper (Joints) Versus Cigar Paper (Blunts)
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.
Read the detailed description
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.
- Conditions
- Marijuana Dependence
- Being tested
- Marijuana blunt, marijuana cigarette
- Keywords
- Marijuana, Comparison between joints and blunts, Pharmacokinetic effects
- Medical subject headings
- Marijuana Abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Marijuana bluntDrug
Also called Blunt
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).
marijuana cigaretteDrug
Also called Joint
Marijuana cigarettes were provided by the National Institute on Drug Abuse.
| Study group | Role | What they receive |
|---|---|---|
| marijuana blunt | Experimental | marijuana blunt (0%, 1.8%, or 3.6% THC) Receives: Drug: Marijuana blunt |
| marijuana cigarette | Experimental | marijuana cigarette (0%, 1.8%, or 3.6% THC) Receives: Drug: marijuana cigarette |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma THC
Plasma THC levels were analyzed to determine pharmacokinetic differences between marijuana cigarettes vs marijuana blunts.
Measured: 180 minutes
Secondary outcomes (4)
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.
Measured: 180 minutes
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
Measured: 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.
Measured: 180 minutes
Heart Rate
Heart rate averaged across all post-smoking time points when marijuana was smoked as joints and blunts.
Measured: 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2006 (estimated)
- Study startDec 2004
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Marijuana DependenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Margaret Haney, Ph.D., Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00374127
- Sponsor's protocol ID
- 4683
- Status last verified
- Jul 2017
- First submitted
- 7 Sep 2006
- Last updated
- 1 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Marijuana Smoked in Cigarette Paper (Joints) Versus Cigar Paper (Blunts)
- ClinicalTrials.gov ID
- NCT00374127
- Acronym / sponsor ID
- 4683
- Conditions
- Marijuana Dependence
- Keywords
- Marijuana, Comparison between joints and blunts, Pharmacokinetic effects
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Dec 2004
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 8 Sep 2006 (estimated)
- Results
- Posted 1 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| marijuana blunt | Experimental | Drug: Marijuana bluntmarijuana blunt (0%, 1.8%, or 3.6% THC) |
| marijuana cigarette | Experimental | Drug: marijuana cigarettemarijuana cigarette (0%, 1.8%, or 3.6% THC) |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Marijuana bluntAlso: BluntBlunts 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). | Drug | marijuana blunt |
| marijuana cigaretteAlso: JointMarijuana cigarettes were provided by the National Institute on Drug Abuse. | Drug | marijuana cigarette |
Primary outcome
Plasma THC
Time frame: 180 minutes
Plasma THC levels were analyzed to determine pharmacokinetic differences between marijuana cigarettes vs marijuana blunts.
4 secondary outcomes
Subjective Effects on MRF
Time frame: 180 minutes
Subjective Effects on VAS
Time frame: 180 minutes
Carbon Monoxide
Time frame: 180 minutes
Heart Rate
Time frame: 180 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret Haney, Ph.D. principal investigator
New York State Psychiatric Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Marijuana blunt and marijuana cigarette in people with Marijuana Dependence, run by New York State Psychiatric Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma THC (time frame: 180 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2017.