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The Effect of Prescription Medications in Marijuana Users

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ClinicalTrials.gov Identifier: NCT00893074
Recruitment Status : Completed
First Posted : May 5, 2009
Results First Posted : August 3, 2017
Last Update Posted : August 3, 2017
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Johns Hopkins University

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Basic Science
Condition: Marijuana Abuse
Interventions: Drug: Dronabinol 30mg/day
Drug: Dronabinol 60mg/day
Drug: Dronabinol 120mg/day
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
0, 30, 60, and 120mg Dronabinol 0, 30, 60, and 120mg Dronabinol administered for 5 consecutive days in a double blind, placebo controlled study, with dose administered in a random order to the same study participants

Participant Flow:   Overall Study
    0, 30, 60, and 120mg Dronabinol
STARTED   24 
COMPLETED   13 
NOT COMPLETED   11 



  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.
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Reporting Groups
  Description
Study Participant Participants who received active drug as part of the study

Baseline Measures
   Study Participant 
Overall Participants Analyzed 
[Units: Participants]
 24 
Age 
[Units: Years]
Mean (Standard Deviation)
 32  (8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      4  16.7% 
Male      20  83.3% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      0   0.0% 
Not Hispanic or Latino      24 100.0% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      22  91.7% 
White      2   8.3% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   24 


  Outcome Measures

1.  Primary:   Peak Effect of Marijuana Withdrawal   [ Time Frame: Day 5 of the Dronabinol abstinence period ]

2.  Primary:   Subjective "Drug Effect" After Smoked Marijuana   [ Time Frame: Day 5 of the Dronabinol abstinence period ]

3.  Secondary:   Heart Rate   [ Time Frame: Assessed on Day 5 of dronabinol maintenance ]


  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
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  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Ryan Vandrey, PhD
Organization: Johns Hopkins University
phone: 410-550-4036
e-mail: rvandrey@jhmi.edu


Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00893074     History of Changes
Other Study ID Numbers: NA_00026278
R01DA025044 ( U.S. NIH Grant/Contract )
First Submitted: April 30, 2009
First Posted: May 5, 2009
Results First Submitted: April 18, 2017
Results First Posted: August 3, 2017
Last Update Posted: August 3, 2017