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Study of Quetiapine Treatment for Cannabis Dependence (STUC)

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ClinicalTrials.gov Identifier: NCT00954681
Recruitment Status : Completed
First Posted : August 7, 2009
Results First Posted : September 6, 2017
Last Update Posted : April 24, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
John Mariani MD, New York State Psychiatric Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cannabis Dependence
Intervention Drug: quetiapine
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Quetiapine Treatment
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Open label treatment with quetiapine

quetiapine: Quetiapine treatment from 25 mg daily to 300 mg twice daily

Period Title: Overall Study
Started 15
Completed 10
Not Completed 5
Arm/Group Title Quetiapine Treatment
Hide Arm/Group Description

Open label treatment with quetiapine

quetiapine: Quetiapine treatment from 25 mg daily to 300 mg twice daily

Overall Number of Baseline Participants 15
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 15 participants
28.2
(18 to 65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Female
4
  26.7%
Male
11
  73.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
Hispanic or Latino
3
  20.0%
Not Hispanic or Latino
12
  80.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 15 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
7
  46.7%
White
3
  20.0%
More than one race
0
   0.0%
Unknown or Not Reported
5
  33.3%
1.Primary Outcome
Title Maximum Tolerated Dose of Quetiapine
Hide Description Mean maximum tolerated dose of quetiapine
Time Frame assesssed daily during 8 weeks of study, mean maximum tolerated dose reported
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Hide Analysis Population Description
Mean maximum dose of quetipaine achieved
Arm/Group Title Open-Label Quetiapine Treatment
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Participants receiving quetiapine under open-label conditions.
Overall Number of Participants Analyzed 15
Mean (Full Range)
Unit of Measure: milligrams
197
(25 to 600)
Time Frame 8 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Quetiapine Treatment
Hide Arm/Group Description

Open label treatment with quetiapine

quetiapine: Quetiapine treatment from 25 mg daily to 300 mg twice daily

All-Cause Mortality
Quetiapine Treatment
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Quetiapine Treatment
Affected / at Risk (%) # Events
Total   0/15 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Quetiapine Treatment
Affected / at Risk (%) # Events
Total   12/15 (80.00%)    
Nervous system disorders   
fatigue   12/15 (80.00%)  12
Indicates events were collected by systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: John J. Mariani
Organization: NYSPI/Columbia University
Phone: 6467746140 ext 646
EMail: john.mariani@nyspi.columbia.edu
Layout table for additonal information
Responsible Party: John Mariani MD, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00954681     History of Changes
Other Study ID Numbers: 5911
K23DA021209 ( U.S. NIH Grant/Contract )
First Submitted: August 5, 2009
First Posted: August 7, 2009
Results First Submitted: August 7, 2017
Results First Posted: September 6, 2017
Last Update Posted: April 24, 2019