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Trial Outcomes & Findings for Lorcaserin for Cannabis Use Disorder (NCT NCT03637842)

NCT ID: NCT03637842

Last Updated: 2021-01-28

Results Overview

descriptive of cannabis use per day captured in daily quartiles based on self report as collected by the Time Line Follow back. The quartiles defined as follows: 12AM-6AM; 6AM-12PM; 12PM-6PM;6PM-12AM. Participants would report if they used during each of these times.

Recruitment status

TERMINATED

Study phase

EARLY_PHASE1

Target enrollment

5 participants

Primary outcome timeframe

13 weeks of study or participants length of participation

Results posted on

2021-01-28

Participant Flow

1 person who was enrolled dropped out of the study prior to randomization. 4 people were randomized in total.

Participant milestones

Participant milestones
Measure
Lorcaserin XR
Lorcaserin XR 20mg daily Lorcaserin: Lorcaserin XR 20mg per day
Placebo
Placebo Oral Capsule Placebo oral capsule: Placebo
Overall Study
STARTED
2
2
Overall Study
COMPLETED
2
2
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lorcaserin for Cannabis Use Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Lorcaserin XR
n=2 Participants
Lorcaserin XR 20mg daily Lorcaserin: Lorcaserin XR 20mg per day
Placebo
n=2 Participants
Placebo Oral Capsule Placebo oral capsule: Placebo
Total
n=4 Participants
Total of all reporting groups
Age, Continuous
24.0 years
STANDARD_DEVIATION 1.4 • n=5 Participants
33.5 years
STANDARD_DEVIATION 16.3 • n=7 Participants
28.8 years
STANDARD_DEVIATION 10.9 • n=5 Participants
Sex: Female, Male
Female
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Sex: Female, Male
Male
2 Participants
n=5 Participants
2 Participants
n=7 Participants
4 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
2 Participants
n=5 Participants
2 Participants
n=7 Participants
4 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=5 Participants
2 Participants
n=7 Participants
2 Participants
n=5 Participants
Race (NIH/OMB)
White
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Region of Enrollment
United States
2 participants
n=5 Participants
2 participants
n=7 Participants
4 participants
n=5 Participants

PRIMARY outcome

Timeframe: 13 weeks of study or participants length of participation

descriptive of cannabis use per day captured in daily quartiles based on self report as collected by the Time Line Follow back. The quartiles defined as follows: 12AM-6AM; 6AM-12PM; 12PM-6PM;6PM-12AM. Participants would report if they used during each of these times.

Outcome measures

Outcome measures
Measure
Lorcaserin XR
n=2 Participants
Lorcaserin XR 20mg daily Lorcaserin: Lorcaserin XR 20mg per day
Placebo
n=2 Participants
Placebo Oral Capsule Placebo oral capsule: Placebo
Number of Participants Who Achieved a Reduction in Cannabis Use Per Daily Quartiles
2 participants
0 participants

Adverse Events

Lorcaserin XR

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Placebo

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Christina Brezing, MD

New York State Psychiatric Institute

Phone: 6467748181

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place