Trial Outcomes & Findings for Study of Quetiapine Treatment for Cannabis Dependence (NCT NCT00954681)

Last Updated: 2019-04-24

Results Overview

Mean maximum tolerated dose of quetiapine

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

15 participants

Primary outcome timeframe

assesssed daily during 8 weeks of study, mean maximum tolerated dose reported

Results posted on

2019-04-24

Participant milestones
Measure	Quetiapine Treatment Open label treatment with quetiapine quetiapine: Quetiapine treatment from 25 mg daily to 300 mg twice daily
Overall Study STARTED	15
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	5

Withdrawal data not reported

Study of Quetiapine Treatment for Cannabis Dependence

Baseline characteristics by cohort
Measure	Quetiapine Treatment n=15 Participants Open label treatment with quetiapine quetiapine: Quetiapine treatment from 25 mg daily to 300 mg twice daily
Age, Continuous	28.2 years n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants

Timeframe: assesssed daily during 8 weeks of study, mean maximum tolerated dose reported

Population: Mean maximum dose of quetipaine achieved

Mean maximum tolerated dose of quetiapine

Outcome measures
Measure	Open-Label Quetiapine Treatment n=15 Participants Participants receiving quetiapine under open-label conditions.
Maximum Tolerated Dose of Quetiapine	197 milligrams Interval 25.0 to 600.0

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Quetiapine Treatment n=15 participants at risk Open label treatment with quetiapine quetiapine: Quetiapine treatment from 25 mg daily to 300 mg twice daily
Nervous system disorders fatigue	80.0% 12/15 • Number of events 12 • 8 weeks

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