Trial Outcomes & Findings for Quetiapine Pharmacotherapy for Cannabis Dependence (NCT NCT01697709)
NCT ID: NCT01697709
Last Updated: 2019-03-05
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
130 participants
Primary outcome timeframe
12 weeks or length of participants involvement
Results posted on
2019-03-05
Participant Flow
Patients were randomized to one of the treatment arms at time of enrollment
Participant milestones
| Measure |
Placebo
Placebo medication
Placebo: placebo capsules
|
Quetiapine
Quetiapine treatment
Quetiapine: Quetiapine pharmacotherapy for cannabis dependence
|
|---|---|---|
|
Overall Study
STARTED
|
64
|
66
|
|
Overall Study
COMPLETED
|
34
|
38
|
|
Overall Study
NOT COMPLETED
|
30
|
28
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Quetiapine Pharmacotherapy for Cannabis Dependence
Baseline characteristics by cohort
| Measure |
Placebo
n=64 Participants
Placebo medication
Placebo: placebo capsules
|
Quetiapine
n=66 Participants
Quetiapine treatment
Quetiapine: Quetiapine pharmacotherapy for cannabis dependence
|
Total
n=130 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.1 years
STANDARD_DEVIATION 8.7 • n=99 Participants
|
32.7 years
STANDARD_DEVIATION 9.5 • n=107 Participants
|
32.9 years
STANDARD_DEVIATION 9.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=99 Participants
|
52 Participants
n=107 Participants
|
102 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
32 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
98 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
32 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
56 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
mood/anxiety disorder
|
14 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Marijuana using days past 28 days
|
26.8 days
STANDARD_DEVIATION 2.1 • n=99 Participants
|
26.4 days
STANDARD_DEVIATION 2.5 • n=107 Participants
|
26.6 days
STANDARD_DEVIATION 2.3 • n=206 Participants
|
PRIMARY outcome
Timeframe: 12 weeks or length of participants involvementThe 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
Outcome measures
| Measure |
Placebo
n=64 Participants
Placebo medication
Placebo: placebo capsules
|
Quetiapine
n=66 Participants
Quetiapine treatment
Quetiapine: Quetiapine pharmacotherapy for cannabis dependence
|
|---|---|---|
|
Marijuana Use, Daily Dollar Averaged Over 7 Days During Each of 12 Weeks of Study
week 1
|
14.00 dollars
Interval 5.42 to 21.25
|
7.00 dollars
Interval 3.18 to 12.86
|
|
Marijuana Use, Daily Dollar Averaged Over 7 Days During Each of 12 Weeks of Study
week 2
|
10.00 dollars
Interval 2.86 to 22.0
|
8.00 dollars
Interval 3.02 to 12.7
|
|
Marijuana Use, Daily Dollar Averaged Over 7 Days During Each of 12 Weeks of Study
week 3
|
7.14 dollars
Interval 2.64 to 17.69
|
5.86 dollars
Interval 3.29 to 11.61
|
|
Marijuana Use, Daily Dollar Averaged Over 7 Days During Each of 12 Weeks of Study
week 4
|
6.43 dollars
Interval 1.61 to 16.25
|
5.71 dollars
Interval 2.57 to 12.0
|
|
Marijuana Use, Daily Dollar Averaged Over 7 Days During Each of 12 Weeks of Study
week 5
|
6.43 dollars
Interval 1.07 to 17.86
|
4.29 dollars
Interval 1.43 to 9.29
|
|
Marijuana Use, Daily Dollar Averaged Over 7 Days During Each of 12 Weeks of Study
week 6
|
5.71 dollars
Interval 0.96 to 13.82
|
4.11 dollars
Interval 1.32 to 9.79
|
|
Marijuana Use, Daily Dollar Averaged Over 7 Days During Each of 12 Weeks of Study
week 7
|
3.70 dollars
Interval 1.03 to 12.59
|
3.57 dollars
Interval 1.43 to 7.52
|
|
Marijuana Use, Daily Dollar Averaged Over 7 Days During Each of 12 Weeks of Study
week 8
|
2.86 dollars
Interval 1.12 to 12.26
|
3.43 dollars
Interval 1.18 to 6.0
|
|
Marijuana Use, Daily Dollar Averaged Over 7 Days During Each of 12 Weeks of Study
week 9
|
6.43 dollars
Interval 1.03 to 11.96
|
3.00 dollars
Interval 1.43 to 7.0
|
|
Marijuana Use, Daily Dollar Averaged Over 7 Days During Each of 12 Weeks of Study
week 10
|
5.35 dollars
Interval 0.0 to 12.32
|
2.86 dollars
Interval 0.29 to 5.14
|
|
Marijuana Use, Daily Dollar Averaged Over 7 Days During Each of 12 Weeks of Study
week 11
|
3.21 dollars
Interval 0.0 to 11.79
|
2.86 dollars
Interval 0.0 to 5.14
|
|
Marijuana Use, Daily Dollar Averaged Over 7 Days During Each of 12 Weeks of Study
week 12
|
1.00 dollars
Interval 0.0 to 12.29
|
2.14 dollars
Interval 0.0 to 5.25
|
PRIMARY outcome
Timeframe: 12 weeks or length of participationPopulation: participants were included in the weekly analysis who were still active in the trial at each given week.
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.
Outcome measures
| Measure |
Placebo
n=64 Participants
Placebo medication
Placebo: placebo capsules
|
Quetiapine
n=66 Participants
Quetiapine treatment
Quetiapine: Quetiapine pharmacotherapy for cannabis dependence
|
|---|---|---|
|
Number of Participants Stratified by Marijuana Abstinence Days Per Week
Week 1 · high use
|
5 Participants
|
4 Participants
|
|
Number of Participants Stratified by Marijuana Abstinence Days Per Week
Week 1 · medium use
|
9 Participants
|
9 Participants
|
|
Number of Participants Stratified by Marijuana Abstinence Days Per Week
Week 1 · low use
|
40 Participants
|
46 Participants
|
|
Number of Participants Stratified by Marijuana Abstinence Days Per Week
Week 2 · high use
|
8 Participants
|
4 Participants
|
|
Number of Participants Stratified by Marijuana Abstinence Days Per Week
Week 2 · medium use
|
7 Participants
|
7 Participants
|
|
Number of Participants Stratified by Marijuana Abstinence Days Per Week
Week 2 · low use
|
34 Participants
|
44 Participants
|
|
Number of Participants Stratified by Marijuana Abstinence Days Per Week
Week 3 · high use
|
9 Participants
|
5 Participants
|
|
Number of Participants Stratified by Marijuana Abstinence Days Per Week
Week 3 · medium use
|
5 Participants
|
14 Participants
|
|
Number of Participants Stratified by Marijuana Abstinence Days Per Week
Week 4 · high use
|
8 Participants
|
8 Participants
|
|
Number of Participants Stratified by Marijuana Abstinence Days Per Week
Week 4 · medium use
|
9 Participants
|
15 Participants
|
|
Number of Participants Stratified by Marijuana Abstinence Days Per Week
Week 4 · low use
|
23 Participants
|
26 Participants
|
|
Number of Participants Stratified by Marijuana Abstinence Days Per Week
Week 5 · high use
|
10 Participants
|
10 Participants
|
|
Number of Participants Stratified by Marijuana Abstinence Days Per Week
Week 5 · medium use
|
7 Participants
|
16 Participants
|
|
Number of Participants Stratified by Marijuana Abstinence Days Per Week
Week 5 · low use
|
22 Participants
|
21 Participants
|
|
Number of Participants Stratified by Marijuana Abstinence Days Per Week
Week 6 · high use
|
13 Participants
|
10 Participants
|
|
Number of Participants Stratified by Marijuana Abstinence Days Per Week
Week 6 · medium use
|
4 Participants
|
13 Participants
|
|
Number of Participants Stratified by Marijuana Abstinence Days Per Week
Week 6 · low use
|
22 Participants
|
23 Participants
|
|
Number of Participants Stratified by Marijuana Abstinence Days Per Week
Week 7 · high use
|
12 Participants
|
11 Participants
|
|
Number of Participants Stratified by Marijuana Abstinence Days Per Week
Week 7 · medium use
|
9 Participants
|
15 Participants
|
|
Number of Participants Stratified by Marijuana Abstinence Days Per Week
Week 8 · medium use
|
9 Participants
|
16 Participants
|
|
Number of Participants Stratified by Marijuana Abstinence Days Per Week
Week 8 · low use
|
17 Participants
|
17 Participants
|
|
Number of Participants Stratified by Marijuana Abstinence Days Per Week
Week 9 · high use
|
13 Participants
|
13 Participants
|
|
Number of Participants Stratified by Marijuana Abstinence Days Per Week
Week 9 · medium use
|
7 Participants
|
15 Participants
|
|
Number of Participants Stratified by Marijuana Abstinence Days Per Week
Week 9 · low use
|
18 Participants
|
15 Participants
|
|
Number of Participants Stratified by Marijuana Abstinence Days Per Week
Week 10 · high use
|
14 Participants
|
13 Participants
|
|
Number of Participants Stratified by Marijuana Abstinence Days Per Week
Week 11 · medium use
|
5 Participants
|
12 Participants
|
|
Number of Participants Stratified by Marijuana Abstinence Days Per Week
Week 11 · low use
|
16 Participants
|
11 Participants
|
|
Number of Participants Stratified by Marijuana Abstinence Days Per Week
Week 12 · high use
|
17 Participants
|
15 Participants
|
|
Number of Participants Stratified by Marijuana Abstinence Days Per Week
Week 3 · low use
|
28 Participants
|
33 Participants
|
|
Number of Participants Stratified by Marijuana Abstinence Days Per Week
Week 7 · low use
|
17 Participants
|
17 Participants
|
|
Number of Participants Stratified by Marijuana Abstinence Days Per Week
Week 8 · high use
|
12 Participants
|
10 Participants
|
|
Number of Participants Stratified by Marijuana Abstinence Days Per Week
Week 10 · medium use
|
5 Participants
|
13 Participants
|
|
Number of Participants Stratified by Marijuana Abstinence Days Per Week
Week 10 · low use
|
17 Participants
|
15 Participants
|
|
Number of Participants Stratified by Marijuana Abstinence Days Per Week
Week 11 · high use
|
15 Participants
|
14 Participants
|
|
Number of Participants Stratified by Marijuana Abstinence Days Per Week
Week 12 · medium use
|
3 Participants
|
11 Participants
|
|
Number of Participants Stratified by Marijuana Abstinence Days Per Week
Week 12 · low use
|
14 Participants
|
11 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
Quetiapine
Serious events: 0 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=64 participants at risk
Placebo medication
Placebo: placebo capsules
|
Quetiapine
n=66 participants at risk
Quetiapine treatment
Quetiapine: Quetiapine pharmacotherapy for cannabis dependence
|
|---|---|---|
|
Cardiac disorders
Hypertension
|
37.5%
24/64 • Number of events 24 • over 12 weeks of study or length of participation
|
54.5%
36/66 • Number of events 36 • over 12 weeks of study or length of participation
|
|
General disorders
Hyperglycemia
|
23.4%
15/64 • Number of events 15 • over 12 weeks of study or length of participation
|
27.3%
18/66 • Number of events 18 • over 12 weeks of study or length of participation
|
|
Endocrine disorders
Dyslipidemia
|
17.2%
11/64 • Number of events 11 • over 12 weeks of study or length of participation
|
15.2%
10/66 • Number of events 10 • over 12 weeks of study or length of participation
|
|
General disorders
drowsiness
|
4.7%
3/64 • Number of events 3 • over 12 weeks of study or length of participation
|
12.1%
8/66 • Number of events 8 • over 12 weeks of study or length of participation
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place