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Comparison Between Marijuana Smoked in Cigarette Paper Versus Cigar Paper

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ClinicalTrials.gov Identifier: NCT00374127
Recruitment Status : Completed
First Posted : September 8, 2006
Results First Posted : September 1, 2017
Last Update Posted : September 1, 2017
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
New York State Psychiatric Institute

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Basic Science
Condition: Marijuana Dependence
Interventions: Drug: Marijuana blunt
Drug: marijuana cigarette

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Prior to enrollment, participants gave written informed consent, received a psychiatric and medical evaluation, and provided a detailed drug use and medical history.

Reporting Groups
Marijuana marijuana blunt (0%, 1.8%, or 3.6% THC) vs. marijuana cigarette (0%, 1.8%, or 3.6% THC)

Participant Flow:   Overall Study
Did not inhale during smoking procedure.                3 
Blood could not be drawn.                2 
Protocol Violation                5 
Pregnancy                1 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Marijuana marijuana blunt (0%, 1.8%, or 3.6% THC) vs. marijuana cigarette (0%, 1.8%, or 3.6% THC)

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
Count of Participants
<=18 years      0   0.0% 
Between 18 and 65 years      24 100.0% 
>=65 years      0   0.0% 
[Units: Years]
Mean (Full Range)
 (21 to 45) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      12  50.0% 
Male      12  50.0% 
Region of Enrollment 
[Units: Participants]
United States   24 

  Outcome Measures

1.  Primary:   Plasma THC   [ Time Frame: 180 minutes ]

2.  Secondary:   Subjective Effects on MRF   [ Time Frame: 180 minutes ]

3.  Secondary:   Subjective Effects on VAS   [ Time Frame: 180 minutes ]

4.  Secondary:   Carbon Monoxide   [ Time Frame: 180 minutes ]

5.  Secondary:   Heart Rate   [ Time Frame: 180 minutes ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.

  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Dr. Meg Haney, Professor of Neurobiology
Organization: New York State Psychiatric Institute at Columbia University Medical Center
phone: 6467746153
e-mail: meg.haney@nyspi.columbia.edu

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00374127     History of Changes
Other Study ID Numbers: 4683
First Submitted: September 7, 2006
First Posted: September 8, 2006
Results First Submitted: August 3, 2017
Results First Posted: September 1, 2017
Last Update Posted: September 1, 2017