Trial Outcomes & Findings for Mechanisms of Lorcaserin for Smoking Cessation (NCT NCT04396834)
NCT ID: NCT04396834
Last Updated: 2023-03-20
Results Overview
Duration (in minutes) until lapsing to smoking during a 50-minute period
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
3 participants
Primary outcome timeframe
Laboratory session following 7 days of medication or placebo pills
Results posted on
2023-03-20
Participant Flow
Three participants provided informed consent. Due to the study being canceled, only two participants were assigned to condition.
Participant milestones
| Measure |
Lorcaserin First, Then Placebo
Participants first receive lorcaserin (10 mg BID) for 7 days. After a washout period of 7 days, they then receive placebo tablets (BID) for 7 days.
|
Placebo First, Then Lorcaserin
Participants first receive placebo (BID) for 7 days. After a washout period of 7 days, they then receive lorcaserin (10 mg BID) for 7 days.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
|
Overall Study
COMPLETED
|
1
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The trial was halted after randomizing the first two participants. Outcomes were not analyzed due to recruitment of only two participants.
Baseline characteristics by cohort
| Measure |
Lorcaserin First, Then Placebo
n=1 Participants
Lorcaserin (10mg BID) for 7 days, then placebo pill (BID) for 7 days
|
Placebo First, Then Lorcaserin
n=1 Participants
Placebo pill (BID) for 7 days, then lorcaserin (10mg BID) for 7 days
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants • The trial was halted after randomizing the first two participants. Outcomes were not analyzed due to recruitment of only two participants.
|
0 Participants
n=7 Participants • The trial was halted after randomizing the first two participants. Outcomes were not analyzed due to recruitment of only two participants.
|
1 Participants
n=5 Participants • The trial was halted after randomizing the first two participants. Outcomes were not analyzed due to recruitment of only two participants.
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants • The trial was halted after randomizing the first two participants. Outcomes were not analyzed due to recruitment of only two participants.
|
1 Participants
n=7 Participants • The trial was halted after randomizing the first two participants. Outcomes were not analyzed due to recruitment of only two participants.
|
1 Participants
n=5 Participants • The trial was halted after randomizing the first two participants. Outcomes were not analyzed due to recruitment of only two participants.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants • The trial was halted after randomizing the first two participants. Outcomes were not analyzed due to recruitment of only two participants.
|
0 Participants
n=7 Participants • The trial was halted after randomizing the first two participants. Outcomes were not analyzed due to recruitment of only two participants.
|
1 Participants
n=5 Participants • The trial was halted after randomizing the first two participants. Outcomes were not analyzed due to recruitment of only two participants.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants • The trial was halted after randomizing the first two participants. Outcomes were not analyzed due to recruitment of only two participants.
|
1 Participants
n=7 Participants • The trial was halted after randomizing the first two participants. Outcomes were not analyzed due to recruitment of only two participants.
|
1 Participants
n=5 Participants • The trial was halted after randomizing the first two participants. Outcomes were not analyzed due to recruitment of only two participants.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • The trial was halted after randomizing the first two participants. Outcomes were not analyzed due to recruitment of only two participants.
|
0 Participants
n=7 Participants • The trial was halted after randomizing the first two participants. Outcomes were not analyzed due to recruitment of only two participants.
|
0 Participants
n=5 Participants • The trial was halted after randomizing the first two participants. Outcomes were not analyzed due to recruitment of only two participants.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants • The trial was halted after randomizing the first two participants. Outcomes were not analyzed due to recruitment of only two participants.
|
0 Participants
n=7 Participants • The trial was halted after randomizing the first two participants. Outcomes were not analyzed due to recruitment of only two participants.
|
0 Participants
n=5 Participants • The trial was halted after randomizing the first two participants. Outcomes were not analyzed due to recruitment of only two participants.
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants • The trial was halted after randomizing the first two participants. Outcomes were not analyzed due to recruitment of only two participants.
|
0 Participants
n=7 Participants • The trial was halted after randomizing the first two participants. Outcomes were not analyzed due to recruitment of only two participants.
|
0 Participants
n=5 Participants • The trial was halted after randomizing the first two participants. Outcomes were not analyzed due to recruitment of only two participants.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • The trial was halted after randomizing the first two participants. Outcomes were not analyzed due to recruitment of only two participants.
|
0 Participants
n=7 Participants • The trial was halted after randomizing the first two participants. Outcomes were not analyzed due to recruitment of only two participants.
|
0 Participants
n=5 Participants • The trial was halted after randomizing the first two participants. Outcomes were not analyzed due to recruitment of only two participants.
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants • The trial was halted after randomizing the first two participants. Outcomes were not analyzed due to recruitment of only two participants.
|
0 Participants
n=7 Participants • The trial was halted after randomizing the first two participants. Outcomes were not analyzed due to recruitment of only two participants.
|
0 Participants
n=5 Participants • The trial was halted after randomizing the first two participants. Outcomes were not analyzed due to recruitment of only two participants.
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants • The trial was halted after randomizing the first two participants. Outcomes were not analyzed due to recruitment of only two participants.
|
1 Participants
n=7 Participants • The trial was halted after randomizing the first two participants. Outcomes were not analyzed due to recruitment of only two participants.
|
2 Participants
n=5 Participants • The trial was halted after randomizing the first two participants. Outcomes were not analyzed due to recruitment of only two participants.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants • The trial was halted after randomizing the first two participants. Outcomes were not analyzed due to recruitment of only two participants.
|
0 Participants
n=7 Participants • The trial was halted after randomizing the first two participants. Outcomes were not analyzed due to recruitment of only two participants.
|
0 Participants
n=5 Participants • The trial was halted after randomizing the first two participants. Outcomes were not analyzed due to recruitment of only two participants.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • The trial was halted after randomizing the first two participants. Outcomes were not analyzed due to recruitment of only two participants.
|
0 Participants
n=7 Participants • The trial was halted after randomizing the first two participants. Outcomes were not analyzed due to recruitment of only two participants.
|
0 Participants
n=5 Participants • The trial was halted after randomizing the first two participants. Outcomes were not analyzed due to recruitment of only two participants.
|
|
Region of Enrollment
United States
|
1 Participants
n=5 Participants • The trial was halted after randomizing the first two participants. Outcomes were not analyzed due to recruitment of only two participants.
|
1 Participants
n=7 Participants • The trial was halted after randomizing the first two participants. Outcomes were not analyzed due to recruitment of only two participants.
|
2 Participants
n=5 Participants • The trial was halted after randomizing the first two participants. Outcomes were not analyzed due to recruitment of only two participants.
|
PRIMARY outcome
Timeframe: Laboratory session following 7 days of medication or placebo pillsPopulation: The trial was halted after randomizing the first two participants.
Duration (in minutes) until lapsing to smoking during a 50-minute period
Outcome measures
| Measure |
Lorcaserin
n=2 Participants
Lorcaserin (10mg BID)
Lorcaserin Oral Tablet: Lorcasering 10mg Oral Tablet (BID)
|
Placebo
n=2 Participants
Placebo pill (BID)
Placebo oral tablet: Placebo Oral Tablet (BID)
|
|---|---|---|
|
Smoking Lapse
|
16.5 minutes
Standard Deviation 4.9
|
30.5 minutes
Standard Deviation .71
|
PRIMARY outcome
Timeframe: Laboratory session following 7 days of medication or placebo pillsPopulation: The trial was halted after randomizing the first two participants.
Number of cigarettes consumed during a 60-minute period
Outcome measures
| Measure |
Lorcaserin
n=2 Participants
Lorcaserin (10mg BID)
Lorcaserin Oral Tablet: Lorcasering 10mg Oral Tablet (BID)
|
Placebo
n=2 Participants
Placebo pill (BID)
Placebo oral tablet: Placebo Oral Tablet (BID)
|
|---|---|---|
|
Laboratory Cigarette Smoking
|
4 number of cigarettes
Standard Deviation 1.41
|
3 number of cigarettes
Standard Deviation 1.41
|
SECONDARY outcome
Timeframe: Laboratory session following 7 days of medication or placebo pills.Population: The trial was halted after randomizing the first two participants.
Performance on a behavioral measure of impulsivity, the stop signal task. Reported is the stop signal reaction time, the number of milliseconds required to activate the "stop" process in the stop signal task.
Outcome measures
| Measure |
Lorcaserin
n=2 Participants
Lorcaserin (10mg BID)
Lorcaserin Oral Tablet: Lorcasering 10mg Oral Tablet (BID)
|
Placebo
n=2 Participants
Placebo pill (BID)
Placebo oral tablet: Placebo Oral Tablet (BID)
|
|---|---|---|
|
Impulsivity
|
280.2 milliseconds
Standard Deviation 11.6
|
255.4 milliseconds
Standard Deviation 34.5
|
SECONDARY outcome
Timeframe: Laboratory session following 7 days of medication or placebo pills.Population: The trial was halted after randomizing the first two participants.
Performance on a behavioral measure of reward sensitivity (response bias measure on a signal detection task). Response bias is computed by the following equation: 1/2 \* log((# correct stim 1 \* # incorrect stim 2)/(# incorrect stim 1 \* # correct stim 2)) Stimulus 1 is associated with a higher proportion of correct feedback than Stimulus 2, and by computing the ratio above, we are able to determine the response bias of the participant. The response bias measure provides an objective measure of reward sensitivity (i.e., the degree to which participants are biased towards choosing the more frequently rewarded response).
Outcome measures
| Measure |
Lorcaserin
n=2 Participants
Lorcaserin (10mg BID)
Lorcaserin Oral Tablet: Lorcasering 10mg Oral Tablet (BID)
|
Placebo
n=2 Participants
Placebo pill (BID)
Placebo oral tablet: Placebo Oral Tablet (BID)
|
|---|---|---|
|
Reward Sensitivity
|
.89 log(ratio)
Standard Deviation .51
|
.80 log(ratio)
Standard Deviation .41
|
SECONDARY outcome
Timeframe: During 7 days of medication or during 7 days of placebo pills (difference score between weeks).Population: The trial was halted after randomizing the first two participants.
Cigarettes smoked per day
Outcome measures
| Measure |
Lorcaserin
n=2 Participants
Lorcaserin (10mg BID)
Lorcaserin Oral Tablet: Lorcasering 10mg Oral Tablet (BID)
|
Placebo
n=2 Participants
Placebo pill (BID)
Placebo oral tablet: Placebo Oral Tablet (BID)
|
|---|---|---|
|
Daily Cigarette Smoking
|
8.79 cigarettes per day
Standard Deviation .30
|
8.79 cigarettes per day
Standard Deviation .30
|
Adverse Events
Lorcaserin
Serious events: 0 serious events
Other events: 1 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
| Measure |
Lorcaserin
n=2 participants at risk
Lorcaserin (10mg BID) for 7 days
|
Placebo
n=2 participants at risk
Placebo pill (BID) for 7 days
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Shingles
|
50.0%
1/2 • Number of events 1 • 1 month
|
0.00%
0/2 • 1 month
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place