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Cannabis for Spasticity in Multiple Sclerosis

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ClinicalTrials.gov Identifier: NCT00682929
Recruitment Status : Terminated (Unable to complete subject recruitment)
First Posted : May 23, 2008
Results First Posted : May 18, 2018
Last Update Posted : May 18, 2018
Sponsor:
Collaborator:
National Multiple Sclerosis Society
Information provided by (Responsible Party):
University of California, Davis

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Multiple Sclerosis
Interventions: Drug: Inhaled Cannabis
Drug: Oral THC
Drug: Oral Placebo
Drug: Inhaled 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
Recruitment period began in April 2004 and continued through 2016. Subjects were recruited from the UC Davis Neurology Clinic and through self-referrals.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
1) Inhaled Cannabis

Inhaled cannabis is compared to oral placebo.

Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.

2) Oral THC

Inhaled placebo is compared to oral THC.

Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.

3) Placebo

Inhaled placebo is compared to oral placebo.

Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.


Participant Flow:   Overall Study
    1) Inhaled Cannabis   2) Oral THC   3) Placebo
STARTED   13   14   14 
COMPLETED   7   9   12 
NOT COMPLETED   6   5   2 
Adverse Event                4                1                1 
Withdrawal by Subject                1                2                1 
dosing compliance < 80%                0                2                0 
lag in DEA renewal                1                0                0 



  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
  Description
1) Inhaled Cannabis

Inhaled cannabis is compared to oral placebo.

Inhaled Cannabis: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo for this group) two and a half hours prior to the inhaled medication. Subjects will take two pills and smoke one cannabis cigarette, daily.

2) Oral THC

Inhaled placebo is compared to oral THC.

Oral THC: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (two 5mg dronabinol tablets) two and a half hours prior to the inhaled medication (placebo for this group). Subjects will take two pills and smoke one cigarette, daily.

3) Placebo

Inhaled placebo is compared to oral placebo.

Placebo: 20 people will be enrolled in this arm of the study and will receive study drug for 7 weeks. Subjects in this arm of the study will be instructed to take their oral medication (placebo) two and a half hours prior to the inhaled medication (placebo). Subjects will take two pills and smoke one cigarette, daily.

Total Total of all reporting groups

Baseline Measures
   1) Inhaled Cannabis   2) Oral THC   3) Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 13   14   14   41 
Age 
[Units: Participants]
Count of Participants
       
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      13 100.0%      13  92.9%      12  85.7%      38  92.7% 
>=65 years      0   0.0%      1   7.1%      2  14.3%      3   7.3% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      5  38.5%      7  50.0%      8  57.1%      20  48.8% 
Male      8  61.5%      7  50.0%      6  42.9%      21  51.2% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
       
Hispanic or Latino      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Not Hispanic or Latino      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      13 100.0%      14 100.0%      14 100.0%      41 100.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      2  15.4%      2  14.3%      1   7.1%      5  12.2% 
White      11  84.6%      12  85.7%      13  92.9%      36  87.8% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
       
United States   13   14   14   41 


  Outcome Measures

1.  Primary:   Change From Week 0 to Week 3 in the Rate of Torque Increase, Flexion   [ Time Frame: Week 0, Week 3 ]

2.  Primary:   Change From Week 0 to Week 3 in the Rate of Torque Increase, Extension   [ Time Frame: Week 0, Week 3 ]

3.  Primary:   Change From Week 0 to Week 7 in the Rate of Torque Increase, Flexion   [ Time Frame: Week 0, Week 7 ]

4.  Primary:   LIDO Machine Score - Rate of Torque Increase, Extension   [ Time Frame: Week 0, Week 7 ]

5.  Secondary:   Change From Week 0 to Week 3 in Modified Ashworth Score (MAS)   [ Time Frame: Week 0, Week 3 ]

6.  Secondary:   Change From Week 0 to Week 7 in Modified Ashworth Score   [ Time Frame: Week 0, Week 7 ]

7.  Secondary:   Change From Week 0 to Week 3 in Ambulation Index (AI) Score   [ Time Frame: Week 0, Week 3 ]

8.  Secondary:   Change From Week 0 to Week 7 in Ambulation Index (AI) Score   [ Time Frame: Week 0, Week 7 ]

9.  Secondary:   Change From Week 0 to Week 3 in 25 Foot Walk Time   [ Time Frame: Week 0, Week 3 ]

10.  Secondary:   Change From Week 0 to Week 7 in 25 Foot Walk Time   [ Time Frame: Week 0, Week 7 ]

11.  Secondary:   Change From Week 0 to Week 3 in 9 Hole Peg Test (Dominant Hand) Time   [ Time Frame: Week 0, Week 3 ]

12.  Secondary:   Change From Week 0 to Week 7 in 9 Hole Peg Test (Dominant Hand) Time   [ Time Frame: Week 0, Week 7 ]

13.  Secondary:   Change From Week 0 to Week 3 in 9 Hole Peg Test (Non- Dominant Hand) Time   [ Time Frame: Week 0, Week 3 ]

14.  Secondary:   Change From Week 0 to Week 7 in 9 Hole Peg Test (Non- Dominant Hand) Time   [ Time Frame: Week 0, Week 7 ]

15.  Secondary:   Change From Week 0 to Week 3 in Paced Auditory Serial Addition Test (PASAT) Score   [ Time Frame: Week 0, Week 3 ]

16.  Secondary:   Change From Week 0 to Week 7 in Paced Auditory Serial Addition Test (PASAT) Score   [ Time Frame: Week 0, Week 7 ]

17.  Secondary:   Change From Week 0 to Week 3 in Functional System Score - Vision   [ Time Frame: Week 0, Week 3 ]

18.  Secondary:   Change From Week 0 to Week 7 in Functional System Score - Vision   [ Time Frame: Week 0, Week 7 ]

19.  Secondary:   Change From Week 0 to Week 3 in Functional System Score - Brainstem   [ Time Frame: Week 0, Week 3 ]

20.  Secondary:   Change From Week 0 to Week 7 in Functional System Score - Brainstem   [ Time Frame: Week 0, Week 7 ]

21.  Secondary:   Change From Week 0 to Week 3 in Functional System Score - Pyramidal   [ Time Frame: Week 0, Week 3 ]

22.  Secondary:   Change From Week 0 to Week 7 in Functional System Score - Pyramidal   [ Time Frame: Week 0, Week 7 ]

23.  Secondary:   Change From Week 0 to Week 3 in Functional System Score - Cerebellar   [ Time Frame: Week 0, Week 3 ]

24.  Secondary:   Change From Week 0 to Week 7 in Functional System Score - Cerebellar   [ Time Frame: Week 0, Week 7 ]

25.  Secondary:   Change From Week 0 to Week 3 in Functional System Score - Sensory   [ Time Frame: Week 0, Week 3 ]

26.  Secondary:   Change From Week 0 to Week 7 in Functional System Score - Sensory   [ Time Frame: Week 0, Week 7 ]

27.  Secondary:   Change From Week 0 to Week 3 in Functional System Score - Bowel and Bladder   [ Time Frame: Week 0, Week 3 ]

28.  Secondary:   Change From Week 0 to Week 7 in Functional System Score - Bowel and Bladder   [ Time Frame: Week 0, Week 7 ]

29.  Secondary:   Change From Week 0 to Week 3 in Functional System Score - Cerebral   [ Time Frame: Week 0, Week 3 ]

30.  Secondary:   Change From Week 0 to Week 7 in Functional System Score - Cerebral   [ Time Frame: Week 0, Week 7 ]

31.  Secondary:   Change From Week 0 to Week 3 in Expanded Disability Status Score (EDSS)   [ Time Frame: Week 0, Week 3 ]

32.  Secondary:   Change From Week 0 to Week 7 in Expanded Disability Status Score (EDSS)   [ Time Frame: Week 0, Week 7 ]

33.  Secondary:   Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - SF-36 Physical Component Score   [ Time Frame: Week 0, Week 3 ]

34.  Secondary:   Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - SF-36 Physical Component Score   [ Time Frame: Week 0, Week 7 ]

35.  Secondary:   Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - SF-36 Mental Component Score   [ Time Frame: Week 0, Week 3 ]

36.  Secondary:   Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - SF-36 Mental Component   [ Time Frame: Week 0, Week 7 ]

37.  Secondary:   Change From Week 0 to Week3 in MS Quality of Life Inventory (MSQLI) - Modified Fatigue Index Score   [ Time Frame: Week 0, Week 3 ]

38.  Secondary:   Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Modified Fatigue Index Score   [ Time Frame: Week 0, Week 7 ]

39.  Secondary:   Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - Pain Effects Scale Score   [ Time Frame: Week 0, Week 3 ]

40.  Secondary:   Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Pain Effects Scale Score   [ Time Frame: Week 0, Week 7 ]

41.  Secondary:   Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - Sexual Satisfaction Scale Score   [ Time Frame: Week 0, Week 3 ]

42.  Secondary:   Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Sexual Satisfaction Scale Score   [ Time Frame: Week 0, Week 7 ]

43.  Secondary:   Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - Bladder Control Scale Score   [ Time Frame: Week 0, Week 3 ]

44.  Secondary:   Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Bladder Control Scale Score   [ Time Frame: Week 0, Week 7 ]

45.  Secondary:   Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - Bowel Control Scale Score   [ Time Frame: Week 0, Week 3 ]

46.  Secondary:   Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Bowel Control Scale Score   [ Time Frame: Week 0, Week 7 ]

47.  Secondary:   Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - Impact of Visual Impairment Scale Score   [ Time Frame: Week 0, Week 3 ]

48.  Secondary:   Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Impact of Visual Impairment Scale Score   [ Time Frame: Week 0, Week 7 ]

49.  Secondary:   Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - Perceived Deficits Scale Score   [ Time Frame: Week 0, Week 3 ]

50.  Secondary:   Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Perceived Deficits Scale Score   [ Time Frame: Week 0, Week 7 ]

51.  Secondary:   Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - Mental Health Inventory Scale Score   [ Time Frame: Week 0, Week 3 ]

52.  Secondary:   Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Mental Health Inventory Scale Score   [ Time Frame: Week 0, Week 7 ]

53.  Secondary:   Change From Week 0 to Week 3 in MS Quality of Life Inventory (MSQLI) - Modified Social Support Scale Score   [ Time Frame: Week 0, Week 3 ]

54.  Secondary:   Change From Week 0 to Week 7 in MS Quality of Life Inventory (MSQLI) - Modified Social Support Scale Score   [ Time Frame: Week 0, Week 7 ]


  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
This study was terminated early due to difficulty with enrollment and logistical issues, despite the enrollment period being extended over several years. Data not analyzed due to insufficient enrollment and funds, as well as the departure of the PI.


  More Information

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


Results Point of Contact:  
Name/Title: Janelle Butters, NP
Organization: UC Davis Health
phone: 916-734-6276
e-mail: jbutters@ucdavis.edu



Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00682929     History of Changes
Other Study ID Numbers: 251429
MS Society Award # RG 3781-A-1 ( Other Grant/Funding Number: MS Society )
First Submitted: May 19, 2008
First Posted: May 23, 2008
Results First Submitted: January 11, 2018
Results First Posted: May 18, 2018
Last Update Posted: May 18, 2018