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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
7 subjects were randomized for this study out of 12 subjects who were screened for this DCCS study at McLean Hospital

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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screened were not randomized. 1 subject stopped using MJ between the screening visit and baseline visit and was thus withdrawn, 2 subjects were no longer interested in the study after screening visit, 1 subject entered in-patient treatment before randomization and 1 screened subject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

Reporting Groups
  Description
Dronabinol-Clonidine

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

Placebo: One placebo capsule by mouth twice daily


Participant Flow:   Overall Study
    Dronabinol-Clonidine   Placebo
STARTED   3   4 
COMPLETED   3   2 
NOT COMPLETED   0   2 
Withdrawal by Subject                0                1 
Lack of Efficacy                0                1 



  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
Dronabinol + Clonidine

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

Placebo: One placebo capsule by mouth twice daily

Total Total of all reporting groups

Baseline Measures
   Dronabinol + Clonidine   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 3   4   7 
Age 
[Units: Years]
Mean (Standard Deviation)
 35.67  (13.58)   30.75  (5.91)   32.86  (9.26) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      1  25.0%      1  14.3% 
Male      3 100.0%      3  75.0%      6  85.7% 
Race (NIH/OMB) 
[Units: Participants]
Count of 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 
[Units: Hits/day]
Mean (Standard Deviation)
 37.16  (21.92)   37.4  (19.32)   37.3  (18.63) 
Marijuana Craving [1] 
[Units: Score on MCQ 4 Factor Total scale]
Mean (Standard Deviation)
 65  (10.15)   55.5  (13.33)   59.57  (12.2) 
[1]

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.



  Outcome Measures

1.  Primary:   Change From Baseline in Cannabis Use at 10 Weeks   [ Time Frame: At 10 weeks ]

2.  Secondary:   Change in Craving Symptoms From Baseline at 10 Weeks   [ Time Frame: At 10 weeks ]

3.  Secondary:   Change From Baseline in Cannabis Use at 14 Weeks   [ Time Frame: At 14 weeks ]

4.  Secondary:   Change in Craving Symptoms From Baseline at 14 Weeks   [ Time Frame: At 14 weeks ]


  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
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.


  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: Dr. Kevin Hill
Organization: Beth Israel Deaconess Medical Center
phone: 617-667-1504
e-mail: khill1@bidmc.harvard.edu



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