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Trial record 22 of 450 for:    QUETIAPINE

Quetiapine Pharmacotherapy for Cannabis Dependence (QUEST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01697709
Recruitment Status : Completed
First Posted : October 2, 2012
Results First Posted : February 5, 2019
Last Update Posted : March 5, 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 Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Cannabis Dependence
Interventions Drug: Quetiapine
Drug: Placebo
Enrollment 130
Recruitment Details  
Pre-assignment Details Patients were randomized to one of the treatment arms at time of enrollment
Arm/Group Title Placebo Quetiapine
Hide Arm/Group Description

Placebo medication

Placebo: placebo capsules

Quetiapine treatment

Quetiapine: Quetiapine pharmacotherapy for cannabis dependence

Period Title: Overall Study
Started 64 66
Completed 34 38
Not Completed 30 28
Arm/Group Title Placebo Quetiapine Total
Hide Arm/Group Description

Placebo medication

Placebo: placebo capsules

Quetiapine treatment

Quetiapine: Quetiapine pharmacotherapy for cannabis dependence

Total of all reporting groups
Overall Number of Baseline Participants 64 66 130
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 64 participants 66 participants 130 participants
33.1  (8.7) 32.7  (9.5) 32.9  (9.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 66 participants 130 participants
Female
14
  21.9%
14
  21.2%
28
  21.5%
Male
50
  78.1%
52
  78.8%
102
  78.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 66 participants 130 participants
Hispanic or Latino
15
  23.4%
17
  25.8%
32
  24.6%
Not Hispanic or Latino
49
  76.6%
49
  74.2%
98
  75.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 66 participants 130 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
3
   4.7%
1
   1.5%
4
   3.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
32
  50.0%
24
  36.4%
56
  43.1%
White
18
  28.1%
25
  37.9%
43
  33.1%
More than one race
3
   4.7%
8
  12.1%
11
   8.5%
Unknown or Not Reported
8
  12.5%
8
  12.1%
16
  12.3%
mood/anxiety disorder  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 66 participants 130 participants
14
  21.9%
14
  21.2%
28
  21.5%
Marijuana using days past 28 days  
Mean (Standard Deviation)
Unit of measure:  Days
Number Analyzed 64 participants 66 participants 130 participants
26.8  (2.1) 26.4  (2.5) 26.6  (2.3)
1.Primary Outcome
Title Marijuana Use, Daily Dollar Averaged Over 7 Days During Each of 12 Weeks of Study
Hide Description The median daily dollar value of marijuana used averaged over a one-week period for each of the 12 weeks as recorded by the Timeline Followback method
Time Frame 12 weeks or length of participants involvement
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Quetiapine
Hide Arm/Group Description:

Placebo medication

Placebo: placebo capsules

Quetiapine treatment

Quetiapine: Quetiapine pharmacotherapy for cannabis dependence

Overall Number of Participants Analyzed 64 66
Median (Inter-Quartile Range)
Unit of Measure: dollars
week 1
14.00
(5.42 to 21.25)
7.00
(3.18 to 12.86)
week 2
10.00
(2.86 to 22.00)
8.00
(3.02 to 12.70)
week 3
7.14
(2.64 to 17.69)
5.86
(3.29 to 11.61)
week 4
6.43
(1.61 to 16.25)
5.71
(2.57 to 12.00)
week 5
6.43
(1.07 to 17.86)
4.29
(1.43 to 9.29)
week 6
5.71
(0.96 to 13.82)
4.11
(1.32 to 9.79)
week 7
3.70
(1.03 to 12.59)
3.57
(1.43 to 7.52)
week 8
2.86
(1.12 to 12.26)
3.43
(1.18 to 6.00)
week 9
6.43
(1.03 to 11.96)
3.00
(1.43 to 7.00)
week 10
5.35
(0.00 to 12.32)
2.86
(0.29 to 5.14)
week 11
3.21
(0.00 to 11.79)
2.86
(0.00 to 5.14)
week 12
1.00
(0.00 to 12.29)
2.14
(0.00 to 5.25)
2.Primary Outcome
Title Number of Participants Stratified by Marijuana Abstinence Days Per Week
Hide Description The number of abstinent days per week over the 12 weeks of study as recorded by the Timeline Followback method. High Use group defined as 0-2 abstinent days per week, Medium Use Group as 3-5 abstinent days per week and Low Use Group as 6-7 abstinent days per week.
Time Frame 12 weeks or length of participation
Hide Outcome Measure Data
Hide Analysis Population Description
participants were included in the weekly analysis who were still active in the trial at each given week.
Arm/Group Title Placebo Quetiapine
Hide Arm/Group Description:

Placebo medication

Placebo: placebo capsules

Quetiapine treatment

Quetiapine: Quetiapine pharmacotherapy for cannabis dependence

Overall Number of Participants Analyzed 64 66
Measure Type: Count of Participants
Unit of Measure: Participants
Week 1 Number Analyzed 54 participants 59 participants
high use
5
   9.3%
4
   6.8%
medium use
9
  16.7%
9
  15.3%
low use
40
  74.1%
46
  78.0%
Week 2 Number Analyzed 49 participants 55 participants
high use
8
  16.3%
4
   7.3%
medium use
7
  14.3%
7
  12.7%
low use
34
  69.4%
44
  80.0%
Week 3 Number Analyzed 42 participants 52 participants
high use
9
  21.4%
5
   9.6%
medium use
5
  11.9%
14
  26.9%
low use
28
  66.7%
33
  63.5%
Week 4 Number Analyzed 40 participants 49 participants
high use
8
  20.0%
8
  16.3%
medium use
9
  22.5%
15
  30.6%
low use
23
  57.5%
26
  53.1%
Week 5 Number Analyzed 39 participants 47 participants
high use
10
  25.6%
10
  21.3%
medium use
7
  17.9%
16
  34.0%
low use
22
  56.4%
21
  44.7%
Week 6 Number Analyzed 39 participants 46 participants
high use
13
  33.3%
10
  21.7%
medium use
4
  10.3%
13
  28.3%
low use
22
  56.4%
23
  50.0%
Week 7 Number Analyzed 38 participants 43 participants
high use
12
  31.6%
11
  25.6%
medium use
9
  23.7%
15
  34.9%
low use
17
  44.7%
17
  39.5%
Week 8 Number Analyzed 38 participants 43 participants
high use
12
  31.6%
10
  23.3%
medium use
9
  23.7%
16
  37.2%
low use
17
  44.7%
17
  39.5%
Week 9 Number Analyzed 38 participants 43 participants
high use
13
  34.2%
13
  30.2%
medium use
7
  18.4%
15
  34.9%
low use
18
  47.4%
15
  34.9%
Week 10 Number Analyzed 36 participants 41 participants
high use
14
  38.9%
13
  31.7%
medium use
5
  13.9%
13
  31.7%
low use
17
  47.2%
15
  36.6%
Week 11 Number Analyzed 36 participants 37 participants
high use
15
  41.7%
14
  37.8%
medium use
5
  13.9%
12
  32.4%
low use
16
  44.4%
11
  29.7%
Week 12 Number Analyzed 34 participants 37 participants
high use
17
  50.0%
15
  40.5%
medium use
3
   8.8%
11
  29.7%
low use
14
  41.2%
11
  29.7%
Time Frame over 12 weeks of study or length of participation
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Quetiapine
Hide Arm/Group Description

Placebo medication

Placebo: placebo capsules

Quetiapine treatment

Quetiapine: Quetiapine pharmacotherapy for cannabis dependence

All-Cause Mortality
Placebo Quetiapine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/64 (0.00%)      0/66 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Quetiapine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/64 (0.00%)      0/66 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Quetiapine
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   34/64 (53.13%)      46/66 (69.70%)    
Cardiac disorders     
Hypertension  [1]  24/64 (37.50%)  24 36/66 (54.55%)  36
Endocrine disorders     
Dyslipidemia  [2]  11/64 (17.19%)  11 10/66 (15.15%)  10
General disorders     
Hyperglycemia  [3]  15/64 (23.44%)  15 18/66 (27.27%)  18
drowsiness   3/64 (4.69%)  3 8/66 (12.12%)  8
Indicates events were collected by systematic assessment
[1]
>130 or > 85
[2]
TG >150mg
[3]
>100 mg
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: john mariani. MD
Organization: NYSPI
Phone: 212-923-3031
EMail: John.mariani@nyspi.columbia.edu
Layout table for additonal information
Responsible Party: John Mariani MD, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT01697709     History of Changes
Other Study ID Numbers: 6623
1R01DA031826 ( U.S. NIH Grant/Contract )
First Submitted: September 28, 2012
First Posted: October 2, 2012
Results First Submitted: January 17, 2019
Results First Posted: February 5, 2019
Last Update Posted: March 5, 2019