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Combination of Dronabinol and Clonidine for Cannabis Dependence in Patients With Schizophrenia (DCCS)

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ClinicalTrials.gov Identifier: NCT01598896
Recruitment Status : Terminated (low enrollment due to limited resources)
First Posted : May 15, 2012
Results First Posted : August 1, 2018
Last Update Posted : August 29, 2018
Sponsor:
Collaborator:
Brain & Behavior Research Foundation
Information provided by (Responsible Party):
Kevin P. Hill, MD, MHS, Mclean Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Cannabis Dependence
Marijuana Dependence
Interventions Drug: Dronabinol
Drug: Clonidine
Drug: Placebo
Enrollment 12

Recruitment Details 7 subjects were randomized for this study out of 12 subjects who were screened for this DCCS study at McLean Hospital
Pre-assignment Details 5 subjects that were screened were not randomized. 1 subject stopped using MJ between the screening visit and baseline visit and was thus withdrawn, 2 subjects were no longer interested in the study after screening visit, 1 subject entered in-patient treatment before randomization and 1 screened subject did not meet DSM criteria for MJ dependence
Arm/Group Title Dronabinol-Clonidine Placebo
Hide Arm/Group Description

Dronabinol titrated to 5 mg three times daily

Dronabinol: Dronabinol titrated to 5 mg three times daily

Clonidine 0.1 mg twice daily

Clonidine: Clonidine 0.1 mg twice daily

Placebo

Placebo: One placebo capsule by mouth twice daily

Period Title: Overall Study
Started 3 4
Completed 3 2
Not Completed 0 2
Reason Not Completed
Withdrawal by Subject             0             1
Lack of Efficacy             0             1
Arm/Group Title Dronabinol + Clonidine Placebo Total
Hide Arm/Group Description

Dronabinol titrated to 5 mg three times daily, Clonidine 0.1 mg twice daily

Dronabinol: Dronabinol titrated to 5 mg three times daily

Clonidine: Clonidine 0.1 mg twice daily

Placebo

Placebo: One placebo capsule by mouth twice daily

Total of all reporting groups
Overall Number of Baseline Participants 3 4 7
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 4 participants 7 participants
35.67  (13.58) 30.75  (5.91) 32.86  (9.26)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 4 participants 7 participants
Female
0
   0.0%
1
  25.0%
1
  14.3%
Male
3
 100.0%
3
  75.0%
6
  85.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 4 participants 7 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
0
   0.0%
1
  25.0%
1
  14.3%
White
3
 100.0%
3
  75.0%
6
  85.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Baseline Self-Report MJ Use  
Mean (Standard Deviation)
Unit of measure:  Hits/day
Number Analyzed 3 participants 4 participants 7 participants
37.16  (21.92) 37.4  (19.32) 37.3  (18.63)
Marijuana Craving   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on MCQ 4 Factor Total scale
Number Analyzed 3 participants 4 participants 7 participants
65  (10.15) 55.5  (13.33) 59.57  (12.2)
[1]
Measure Description:

The baseline Marijuana Craving Questionnaire (Heishman et al. 2009) - The 4 Factor Total Score

Maximum Score = 84 Minimum Score = 12 The higher the score, the more severe marijuana craving symptoms endorsed by the subject.

1.Primary Outcome
Title Change From Baseline in Cannabis Use at 10 Weeks
Hide Description Subject self-report hits of marijuana per day at week 10
Time Frame At 10 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only 2 of the 4 placebo subjects had Week 10 data due to dropping out of the study.
Arm/Group Title Dronabinol + Clonidine Placebo
Hide Arm/Group Description:

Dronabinol titrated to 5 mg three times daily, Clonidine 0.1 mg twice daily

Dronabinol: Dronabinol titrated to 5 mg three times daily

Clonidine: Clonidine 0.1 mg twice daily

Placebo

Placebo: One placebo capsule by mouth twice daily

Overall Number of Participants Analyzed 3 2
Mean (Standard Deviation)
Unit of Measure: hits/day
16.91  (14.57) 22.35  (17.47)
2.Secondary Outcome
Title Change in Craving Symptoms From Baseline at 10 Weeks
Hide Description

Scores on the Marijuana Craving Questionnaire (MCQ) (Heishman et al. 2009) - The 4 Factor Total Score.

Maximum Score = 84 Minimum Score = 12 The higher the score, the more severe marijuana craving symptoms endorsed by the subject.

Time Frame At 10 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only 2 of the placebo subjects completed week 10 and had MCQ scores for Week 10.
Arm/Group Title Dronabinol + Clonidine Placebo
Hide Arm/Group Description:

Dronabinol titrated to 5 mg three times daily, Clonidine 0.1 mg twice daily

Dronabinol: Dronabinol titrated to 5 mg three times daily

Clonidine: Clonidine 0.1 mg twice daily

Placebo

Placebo: One placebo capsule by mouth twice daily

Overall Number of Participants Analyzed 3 2
Mean (Standard Deviation)
Unit of Measure: score on a MCQ 4 Factor Total scale
51  (15.71) 52.33  (15.04)
3.Secondary Outcome
Title Change From Baseline in Cannabis Use at 14 Weeks
Hide Description Self-report cannabis use at 14 weeks after initiating the study.
Time Frame At 14 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only 1 of the placebo subjects had week 14 data due to the other week 10 completer not attending the follow-up visit at week 14.
Arm/Group Title Dronabinol + Clonidine Placebo
Hide Arm/Group Description:

Dronabinol titrated to 5 mg three times daily, Clonidine 0.1 mg twice daily

Dronabinol: Dronabinol titrated to 5 mg three times daily

Clonidine: Clonidine 0.1 mg twice daily

Placebo

Placebo: One placebo capsule by mouth twice daily

Overall Number of Participants Analyzed 3 1
Mean (Standard Deviation)
Unit of Measure: hits/day
18.95  (6.69) 16.29  (0)
4.Secondary Outcome
Title Change in Craving Symptoms From Baseline at 14 Weeks
Hide Description

Scores on the Marijuana Craving Questionnaire (Heishman et al. 2009) - The 4 Factor Total Score

Maximum Score = 84 Minimum Score = 12 The higher the score, the more severe marijuana craving symptoms endorsed by the subject.

Time Frame At 14 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only 1 placebo subject completed Week 14 of the study and had Week 14 MCQ Total Score data.
Arm/Group Title Dronabinol + Clonidine Placebo
Hide Arm/Group Description:

Dronabinol titrated to 5 mg three times daily, Clonidine 0.1 mg twice daily

Dronabinol: Dronabinol titrated to 5 mg three times daily

Clonidine: Clonidine 0.1 mg twice daily

Placebo

Placebo: One placebo capsule by mouth twice daily

Overall Number of Participants Analyzed 3 1
Mean (Standard Deviation)
Unit of Measure: score on MCQ Total 4 Factor scale
54.33  (9.29) 56  (0)
Time Frame Adverse event data was collected every visit starting with the baseline visits up until the last visit of the study 14 weeks later.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dronabinol + Clonidine Placebo
Hide Arm/Group Description

Dronabinol titrated to 5 mg three times daily, Clonidine 0.1 mg twice daily

Dronabinol: Dronabinol titrated to 5 mg three times daily

Clonidine: Clonidine 0.1 mg twice daily

Placebo

Placebo: One placebo capsule by mouth twice daily

All-Cause Mortality
Dronabinol + Clonidine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/3 (0.00%)      0/4 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Dronabinol + Clonidine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      0/4 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dronabinol + Clonidine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      1/4 (25.00%)    
General disorders     
Nausea associated with Placebo  [1]  0/3 (0.00%)  0 1/4 (25.00%)  1
Indicates events were collected by systematic assessment
[1]
1 subject called study staff to say the medication was making her nauseous. When subject was called back, the nausea was gone and did not occur again. The PI called the subject who stated it must have been unrelated to study
Due to lack of sufficient funds/resources, the sample size for this study is not large enough to extract any conclusive results. The high number of subjects withdrawing from the study early also hinders any possible conclusions.
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. Kevin Hill
Organization: Beth Israel Deaconess Medical Center
Phone: 617-667-1504
Responsible Party: Kevin P. Hill, MD, MHS, Mclean Hospital
ClinicalTrials.gov Identifier: NCT01598896     History of Changes
Other Study ID Numbers: 2010P-002262
Brain and Behavior Research ( Other Identifier: Brain and Behavior Research Foundation )
First Submitted: May 11, 2012
First Posted: May 15, 2012
Results First Submitted: July 9, 2018
Results First Posted: August 1, 2018
Last Update Posted: August 29, 2018