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Vaporized Cannabis for Chronic Pain Associated With Sickle Cell Disease (Cannabis-SCD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01771731
Recruitment Status : Completed
First Posted : January 18, 2013
Results First Posted : August 18, 2020
Last Update Posted : August 18, 2020
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
University of Minnesota
Information provided by (Responsible Party):
University of California, San Francisco

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Sickle Cell Disease
Intervention Drug: Cannabis
Enrollment 27
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Cannabis First, Then Placebo Placebo First, Then Cannabis
Hide Arm/Group Description This group received active THC:CBD cannabis during their first 5-day inpatient admission and placebo during the second admission. This group received placebo cannabis during their first 5-day inpatient admission and THC:CBD cannabis during the second.
Period Title: Overall Study
Started 13 14
Completed 11 12
Not Completed 2 2
Reason Not Completed
Physician Decision             1             0
Protocol Violation             0             1
Adverse event: Pain Crisis             1             1
Arm/Group Title Cannabis First, Then Placebo Placebo First, Then Cannabis Total
Hide Arm/Group Description

Contents of 1 cannabis cigarette (4.7% THC/5.1% CBD) will be vaporized and inhaled at 12pm on Day 1; 8am, 2pm and 8pm on Days 2-4; and 8am on Day 5.

Contents of 1 placebo cigarette (0% THC/0% CBD) will be vaporized and inhaled at 12pm on Day 1; 8am, 2pm and 8pm on Days 2-4; and 8am on Day 5.

Contents of 1 placebo cigarette (0% THC/0% CBD) will be vaporized and inhaled at 12pm on Day 1; 8am, 2pm and 8pm on Days 2-4; and 8am on Day 5.

Contents of 1 cannabis cigarette (4.7% THC/5.1% CBD) will be vaporized and inhaled at 12pm on Day 1; 8am, 2pm and 8pm on Days 2-4; and 8am on Day 5.

Total of all reporting groups
Overall Number of Baseline Participants 13 14 27
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 13 participants 14 participants 27 participants
39.7  (12.8) 33.3  (8.7) 36.4  (11.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 14 participants 27 participants
Female
7
  53.8%
9
  64.3%
16
  59.3%
Male
6
  46.2%
5
  35.7%
11
  40.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 14 participants 27 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
13
 100.0%
11
  78.6%
24
  88.9%
White
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
3
  21.4%
3
  11.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Pain Rating Using Visual Analog Scale at Day 1 and Day 5
Hide Description Visual analog scale (VAS) used to assess pain. The scale range is 0-100, lower score means lower pain, higher score means higher pain.
Time Frame Day 1 and Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
All participants received both interventions.
Arm/Group Title Cannabis Placebo
Hide Arm/Group Description:
Contents of 1 cannabis cigarette (4.7% THC/5.1% CBD) will be vaporized and inhaled at 12pm on Day 1; 8am, 2pm and 8pm on Days 2-4; and 8am on Day 5.
Contents of 1 placebo cigarette (0% THC/0% CBD) will be vaporized and inhaled at 12pm on Day 1; 8am, 2pm and 8pm on Days 2-4; and 8am on Day 5.
Overall Number of Participants Analyzed 23 23
Mean (95% Confidence Interval)
Unit of Measure: score on a scale
Day 1
40.5
(29.3 to 51.7)
45.8
(34.3 to 57.3)
Day 5
30.3
(19 to 41.6)
38.5
(28.6 to 48.4)
Time Frame Adverse events were collected during the two 5-day admission periods separated by one month
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cannabis Placebo
Hide Arm/Group Description Contents of 1 cannabis cigarette (4.7% THC/5.1% CBD) will be vaporized and inhaled at 12pm on Day 1; 8am, 2pm and 8pm on Days 2-4; and 8am on Day 5. Contents of 1 placebo cigarette (0% THC/0% CBD) will be vaporized and inhaled at 12pm on Day 1; 8am, 2pm and 8pm on Days 2-4; and 8am on Day 5.
All-Cause Mortality
Cannabis Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/23 (0.00%) 
Hide Serious Adverse Events
Cannabis Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/23 (0.00%)   0/23 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cannabis Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   13/23 (56.52%)   12/23 (52.17%) 
Nervous system disorders     
Anxiety   9/23 (39.13%)  7/23 (30.43%) 
Sedation   13/23 (56.52%)  12/23 (52.17%) 
Disorientation   2/23 (8.70%)  3/23 (13.04%) 
Paranoia   1/23 (4.35%)  1/23 (4.35%) 
Confusion   2/23 (8.70%)  2/23 (8.70%) 
Dizziness   6/23 (26.09%)  3/23 (13.04%) 
Nausea   4/23 (17.39%)  6/23 (26.09%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Donald I. Abrams, MD
Organization: University of California San Francisco
Phone: 415-476-4082 ext 444
EMail: Donald.Abrams@ucsf.edu
Layout table for additonal information
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01771731    
Other Study ID Numbers: U54HL117664-01
6610 ( Other Identifier: UCSF Clinical and Translational Science Institute )
First Submitted: January 14, 2013
First Posted: January 18, 2013
Results First Submitted: September 3, 2019
Results First Posted: August 18, 2020
Last Update Posted: August 18, 2020