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Ph1 Marinol Interaction Study - Part 2 - 1

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ClinicalTrials.gov Identifier: NCT00490269
Recruitment Status : Completed
First Posted : June 22, 2007
Results First Posted : April 8, 2013
Last Update Posted : January 12, 2017
Sponsor:
Information provided by (Responsible Party):
, National Institute on Drug Abuse (NIDA)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Condition Marijuana Dependence
Interventions Drug: Placebo
Drug: Dronabinol
Enrollment 12
Recruitment Details Recruitment was from October 31, 2006 to December 5, 2007. The study was conducted at the NIDA funded clinical pharmacology unit (CPU) at Uniformed Services University for the Health Sciences (USUHS).
Pre-assignment Details Volunteers meeting the maximum 28-day screening assessment period and eligibility criteria were enrolled into the Phase-1 clinical trial. The subjects had to meet the following criteria to be eligible: be non-treatment seeking, experienced marijuana users with dependence for the past year, and subjects that were in good general health.
Arm/Group Title Dronabinol Placebo
Hide Arm/Group Description Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800. Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800.
Period Title: Dronabinol Then Placebo
Started 6 6
Completed 6 6
Not Completed 0 0
Period Title: Placebo Then Dronabinol
Started 6 6
Completed 6 6
Not Completed 0 0
Arm/Group Title Dronabinol Placebo Total
Hide Arm/Group Description Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800. Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800. Total of all reporting groups
Overall Number of Baseline Participants 6 6 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
6
 100.0%
6
 100.0%
12
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 12 participants
27.2  (3.6) 27.2  (4.9) 27.2  (4.3)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
Female
2
  33.3%
1
  16.7%
3
  25.0%
Male
4
  66.7%
5
  83.3%
9
  75.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 6 participants 12 participants
6 6 12
1.Primary Outcome
Title Number of Participants That Experience Cardiovascular Effects of Smoked Marijuana or Has Any Other Combination Side Effects.
Hide Description Does dronabinol (when given during smoking of a marijuana cigarette) show changes in the number of participants that experience cardiovascular effects of smoked marijuana or has any other combination side effects.
Time Frame Day 9 and 10
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Dronabinol Placebo
Hide Arm/Group Description:
Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800.
Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800.
Overall Number of Participants Analyzed 6 6
Measure Type: Number
Unit of Measure: participants
6 6
Time Frame Adverse events were collected starting on Day 0 through Day 12
Adverse Event Reporting Description If a subject experienced more than one adverse events (AE), it would be recorded as a separate AE.
 
Arm/Group Title Dronabinol Placebo
Hide Arm/Group Description Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800. Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800.
All-Cause Mortality
Dronabinol Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Dronabinol Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/6 (16.67%)      0/6 (0.00%)    
Nervous system disorders     
Anxiety Disorder * 1  1/6 (16.67%)  1 0/6 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dronabinol Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/6 (100.00%)      1/6 (16.67%)    
Cardiac disorders     
Palpitations * 1  1/6 (16.67%)  0/6 (0.00%) 
Gastrointestinal disorders     
Nausea * 1 [1]  1/6 (16.67%)  0/6 (0.00%) 
Lip ulceration  1  0/6 (0.00%)  1/6 (16.67%) 
General disorders     
Fatigue * 1 [1]  1/6 (16.67%)  0/6 (0.00%) 
Catheter site hemmorage  1  1/6 (16.67%)  0/6 (0.00%) 
Catheter site adema  1  1/6 (16.67%)  0/6 (0.00%) 
Injection site inflammation  1  1/6 (16.67%)  0/6 (0.00%) 
Hepatobiliary disorders     
Transamenase Increase  1 [2]  1/6 (16.67%)  0/6 (0.00%) 
Metabolism and nutrition disorders     
Decrease in Appetite (NOS) * 1 [1]  1/6 (16.67%)  0/6 (0.00%) 
Nervous system disorders     
Headache * 1 [1]  1/6 (16.67%)  0/6 (0.00%) 
Syncope  1 [3]  1/6 (16.67%)  0/6 (0.00%) 
Insomnolence * 1 [1]  1/6 (16.67%)  0/6 (0.00%) 
Psychiatric disorders     
Anxiety * 1 [4]  1/6 (16.67%)  0/6 (0.00%) 
Anxiety disorders and symptoms * 1 [1]  1/6 (16.67%)  0/6 (0.00%) 
Irritability * 1 [1]  1/6 (16.67%)  0/6 (0.00%) 
Reproductive system and breast disorders     
Polymenorrhea  1 [5]  1/6 (16.67%)  0/6 (0.00%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
[1]
Mild adverse event; possibly related to study drug.
[2]
Moderate adverse event; possibly related to study drug.
[3]
Moderate adverse event, remotely related to study drug.
[4]
Moderate adverse even; probably related to study drug.
[5]
Mild adverse event and possibly related to study drug.
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: Dr. Lou Cantelina
Organization: Uniformed Services University for the Health Sciences
Phone: 301-295-3240
Responsible Party: , National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00490269     History of Changes
Other Study ID Numbers: NIDA-CPU-0013-1
First Submitted: June 21, 2007
First Posted: June 22, 2007
Results First Submitted: December 19, 2012
Results First Posted: April 8, 2013
Last Update Posted: January 12, 2017