Trial Outcomes & Findings for Effect of Lorcaserin on Cannabis Withdrawal and Self-administration (NCT NCT03253926)
NCT ID: NCT03253926
Last Updated: 2022-07-26
Results Overview
Number of cannabis puffs participant chooses to smoke.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
15 participants
Primary outcome timeframe
14 days
Results posted on
2022-07-26
Participant Flow
Participants were enrolled in this study comprising two 13-day inpatient phases, each of which was preceded by two medication administration outpatient days to achieve steady-state levels prior to key behavioral measures. Each phase tested a different medication condition (lorcaserin 10 mg or placebo BID) in a within-subject design, with at least one medication-free week between phases to allow for medication clearance.
Participant milestones
| Measure |
Lorcaserin + Marijuana First, Then Placebo + Marijuana
Lorcaserin: Lorcaserin 10mg or 0mg BID
Marijuana: Smoked marijuana cigarette
|
Placebo + Marijuana First, Then Lorcaserin + Marijuana
Lorcaserin: Lorcaserin 10mg or 0mg BID
Marijuana: Smoked marijuana cigarette
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
8
|
|
Overall Study
COMPLETED
|
7
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Lorcaserin on Cannabis Withdrawal and Self-administration
Baseline characteristics by cohort
| Measure |
Lorcaserin + Marijuana
n=15 Participants
Lorcaserin: Lorcaserin 10mg or 0mg BID
Marijuana: Smoked marijuana cigarette
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
30.9 years
STANDARD_DEVIATION 7.7 • n=99 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 14 daysPopulation: Participants were randomly counterbalanced into each condition, such that all participants contributed to all conditions.
Number of cannabis puffs participant chooses to smoke.
Outcome measures
| Measure |
Lorcaserin + Marijuana
n=15 Participants
Lorcaserin: Lorcaserin 10mg BID
Marijuana: Smoked marijuana cigarette
|
Placebo + Marijuana
n=15 Participants
Placebo: Placebo capsule BID
Marijuana: Smoked marijuana cigarette
|
|---|---|---|
|
Cannabis Self-administration
Cannabis relapse: choice of cannabis puffs following 3 days of abstinence
|
5.75 puffs of cannabis chosen
Standard Error 1
|
9.2 puffs of cannabis chosen
Standard Error 1
|
|
Cannabis Self-administration
Cannabis abstinence initiation: choice of cannabis puffs following 0 days of abstinence
|
5.75 puffs of cannabis chosen
Standard Error 1
|
7.5 puffs of cannabis chosen
Standard Error 1
|
Adverse Events
Lorcaserin + Marijuana
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Placebo + Marijuana
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lorcaserin + Marijuana
n=15 participants at risk
Lorcaserin: Lorcaserin 10mg BID
Marijuana: Smoked marijuana cigarette
|
Placebo + Marijuana
n=15 participants at risk
Placebo: Placebo capsule BID
Marijuana: Smoked marijuana cigarette
|
|---|---|---|
|
Product Issues
Headache
|
20.0%
3/15 • Number of events 5 • Data reflect the number of participants reporting an adverse event during the inpatient phase (11 days) as a function of lorcaserin dose (0 mg or 10 mg BID). No serious adverse events were reported.
|
6.7%
1/15 • Number of events 1 • Data reflect the number of participants reporting an adverse event during the inpatient phase (11 days) as a function of lorcaserin dose (0 mg or 10 mg BID). No serious adverse events were reported.
|
|
Product Issues
Gastrointestinal upset
|
40.0%
6/15 • Number of events 11 • Data reflect the number of participants reporting an adverse event during the inpatient phase (11 days) as a function of lorcaserin dose (0 mg or 10 mg BID). No serious adverse events were reported.
|
26.7%
4/15 • Number of events 4 • Data reflect the number of participants reporting an adverse event during the inpatient phase (11 days) as a function of lorcaserin dose (0 mg or 10 mg BID). No serious adverse events were reported.
|
|
Product Issues
Body pain
|
6.7%
1/15 • Number of events 1 • Data reflect the number of participants reporting an adverse event during the inpatient phase (11 days) as a function of lorcaserin dose (0 mg or 10 mg BID). No serious adverse events were reported.
|
6.7%
1/15 • Number of events 1 • Data reflect the number of participants reporting an adverse event during the inpatient phase (11 days) as a function of lorcaserin dose (0 mg or 10 mg BID). No serious adverse events were reported.
|
|
Product Issues
Anxiety/Jittery
|
6.7%
1/15 • Number of events 1 • Data reflect the number of participants reporting an adverse event during the inpatient phase (11 days) as a function of lorcaserin dose (0 mg or 10 mg BID). No serious adverse events were reported.
|
6.7%
1/15 • Number of events 1 • Data reflect the number of participants reporting an adverse event during the inpatient phase (11 days) as a function of lorcaserin dose (0 mg or 10 mg BID). No serious adverse events were reported.
|
|
Product Issues
Eye dryness/discomfort
|
13.3%
2/15 • Number of events 4 • Data reflect the number of participants reporting an adverse event during the inpatient phase (11 days) as a function of lorcaserin dose (0 mg or 10 mg BID). No serious adverse events were reported.
|
6.7%
1/15 • Number of events 1 • Data reflect the number of participants reporting an adverse event during the inpatient phase (11 days) as a function of lorcaserin dose (0 mg or 10 mg BID). No serious adverse events were reported.
|
|
Product Issues
Trouble sleeping
|
13.3%
2/15 • Number of events 2 • Data reflect the number of participants reporting an adverse event during the inpatient phase (11 days) as a function of lorcaserin dose (0 mg or 10 mg BID). No serious adverse events were reported.
|
0.00%
0/15 • Data reflect the number of participants reporting an adverse event during the inpatient phase (11 days) as a function of lorcaserin dose (0 mg or 10 mg BID). No serious adverse events were reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place