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Treatment of Schizophrenia and Comorbid Cannabis Use Disorder: Comparing Clozapine to Treatment-as-Usual

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ClinicalTrials.gov Identifier: NCT00498550
Recruitment Status : Completed
First Posted : July 10, 2007
Results First Posted : January 19, 2012
Last Update Posted : March 13, 2019
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
University of Missouri, Kansas City
VA Medical Center-West Los Angeles
University of South Carolina
Information provided by (Responsible Party):
Alan Green, Dartmouth-Hitchcock Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Schizophrenia
Dual Diagnosis
Schizoaffective Disorder
Psychotic Disorder
Cannabis Abuse
Interventions Drug: Clozapine
Drug: Treatment as usual
Enrollment 31
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Clozapine Treatment as Usual
Hide Arm/Group Description Clozapine, Clozaril Treatment as usual with any antipsychotic other than Clozapine.
Period Title: Overall Study
Started 15 16
Completed 15 [1] 15
Not Completed 0 1
[1]
13 of 15 received clozapine all 12 visits, two discontinued clozapine early but remained in study.
Arm/Group Title Clozapine Treatment as Usual Total
Hide Arm/Group Description Clozapine, Clozaril Treatment as usual with any antipsychotic other than Clozapine. Total of all reporting groups
Overall Number of Baseline Participants 15 16 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 16 participants 31 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
15
 100.0%
16
 100.0%
31
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 15 participants 16 participants 31 participants
33.3  (10.0) 39.0  (10.2) 36  (10.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants 16 participants 31 participants
Female
3
  20.0%
4
  25.0%
7
  22.6%
Male
12
  80.0%
12
  75.0%
24
  77.4%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 15 participants 16 participants 31 participants
15
 100.0%
16
 100.0%
31
 100.0%
1.Primary Outcome
Title Average Over Time of Intensity of Cannabis Use (Used to Evaluate Treatment Efficacy)
Hide Description Intensity of cannabis use is obtained for each week retrospectively as the number of joints smoked during the prior week (assessed by the Timeline Followback Scale). Mixed models are used to obtain estimates of efficacy from the partial data provided by each subject while adherent to assigned treatment (under the 'missing at random' assumption). The 'explanatory' estimands (target of the mixed model estimation) are defined in terms of population quantities that would have occurred had all subjects remained on assigned treatment throughout the study. The point estimate for each arm is reported under Number.
Time Frame Week 1 to week 12
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Clozapine Treatment as Usual
Hide Arm/Group Description:
Clozapine, Clozaril
Treatment as usual with any antipsychotic other than Clozapine.
Overall Number of Participants Analyzed 15 16
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Joints per week
0.02
(-2.1 to 2.5)
4.56
(-0.2 to 9.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Clozapine, Treatment as Usual
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .088
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter difference in treatment means
Estimated Value -4.54
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.57
Estimation Comments We report the estimated coefficient for difference in treatment means in a mixed model and its standard error.
Time Frame 12 Weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Clozapine Treatment as Usual
Hide Arm/Group Description Clozapine, Clozaril Treatment as usual with any antipsychotic other than Clozapine.
All-Cause Mortality
Clozapine Treatment as Usual
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Clozapine Treatment as Usual
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/15 (26.67%)      4/16 (25.00%)    
Gastrointestinal disorders     
Vomiting  1  1/15 (6.67%)  1 0/16 (0.00%)  0
Pancreatitis  1  0/15 (0.00%)  0 1/16 (6.25%)  2
General disorders     
Non-Cardiac Chest Pain  1  0/15 (0.00%)  0 1/16 (6.25%)  1
Psychiatric disorders     
Psychiatric Disorder - Other: Accidental Overdose  1  0/15 (0.00%)  0 1/16 (6.25%)  1
Suicide Attempt  1  1/15 (6.67%)  1 1/16 (6.25%)  2
Depression  1  1/15 (6.67%)  1 0/16 (0.00%)  0
Psychosis  1  1/15 (6.67%)  1 0/16 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCEA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Clozapine Treatment as Usual
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   15/15 (100.00%)      15/16 (93.75%)    
Cardiac disorders     
Hypertension  1  2/15 (13.33%)  2 2/16 (12.50%)  2
Gastrointestinal disorders     
Constipation  1  4/15 (26.67%)  4 0/16 (0.00%)  0
Dry Mouth  1  2/15 (13.33%)  3 2/16 (12.50%)  2
Gastrointestinal Disorder - Other: Hypersalivation  1  10/15 (66.67%)  11 0/16 (0.00%)  0
Nausea  1  2/15 (13.33%)  5 1/16 (6.25%)  1
Vomiting  1  2/15 (13.33%)  2 3/16 (18.75%)  3
General disorders     
Fatigue  1  3/15 (20.00%)  3 0/16 (0.00%)  0
Flu Like Symptoms  1  0/15 (0.00%)  0 2/16 (12.50%)  2
Irritability  1  1/15 (6.67%)  1 1/16 (6.25%)  1
Non-Cardiac Chest Pain  1  1/15 (6.67%)  1 1/16 (6.25%)  1
Investigations     
Weight Gain  1  6/15 (40.00%)  7 2/16 (12.50%)  3
Musculoskeletal and connective tissue disorders     
Musculoskeletal And Connective Tissue Disorder - Other: Muscle Spasms  1  2/15 (13.33%)  2 0/16 (0.00%)  0
Nervous system disorders     
Akathisia  1  1/15 (6.67%)  1 1/16 (6.25%)  1
Dizziness  1  5/15 (33.33%)  8 1/16 (6.25%)  1
Headache  1  2/15 (13.33%)  3 1/16 (6.25%)  1
Nervous Sytem Disorder - Other: Unusual Dream Activity  1  0/15 (0.00%)  0 2/16 (12.50%)  2
Somnolence  1  9/15 (60.00%)  12 2/16 (12.50%)  2
Psychiatric disorders     
Agitation  1  1/15 (6.67%)  1 1/16 (6.25%)  1
Depression  1  1/15 (6.67%)  1 1/16 (6.25%)  1
Insomnia  1  2/15 (13.33%)  2 1/16 (6.25%)  1
Renal and urinary disorders     
Urinary Incontinence  1  2/15 (13.33%)  2 0/16 (0.00%)  0
Reproductive system and breast disorders     
Libido Decreased  1  1/15 (6.67%)  1 1/16 (6.25%)  1
Respiratory, thoracic and mediastinal disorders     
Nasal Congestion  1  0/15 (0.00%)  0 2/16 (12.50%)  3
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCEA
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: Christopher OKeefe
Organization: Dartmouth Medical School
Phone: 603-271-5287
Responsible Party: Alan Green, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT00498550     History of Changes
Obsolete Identifiers: NCT00149955
Other Study ID Numbers: R01DA013196 ( U.S. NIH Grant/Contract )
DPMCDA
First Submitted: July 6, 2007
First Posted: July 10, 2007
Results First Submitted: September 28, 2011
Results First Posted: January 19, 2012
Last Update Posted: March 13, 2019