Trial Outcomes & Findings for Laboratory Screening of Lorcaserin for Alcohol Use Disorder (NCT NCT04396847)
NCT ID: NCT04396847
Last Updated: 2022-09-07
Results Overview
Number of drinks consumed during a 2-hour alcohol self-administration session
TERMINATED
PHASE2
5 participants
Laboratory session following 7 days of medication or laboratory session following 7 days of placebo pills.
2022-09-07
Participant Flow
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
|
0
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Laboratory Screening of Lorcaserin for Alcohol Use Disorder
Baseline characteristics by cohort
| Measure |
Lorcaserin First, Then Placebo
n=1 Participants
Lorcaserin (10mg BID), then placebo pill (BID)
|
Placebo First, Then Lorcaserin
Placebo pill (BID), then Lorcaserin (10mg BID)
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
—
|
1 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 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
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 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
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Laboratory session following 7 days of medication or laboratory session following 7 days of placebo pills.Population: The trial was halted after randomizing the first two participants. Only one participant completed the dependent measures.
Number of drinks consumed during a 2-hour alcohol self-administration session
Outcome measures
| Measure |
Lorcaserin
n=1 Participants
Lorcaserin (10mg BID)
Lorcaserin Oral Tablet: Lorcasering 10mg Oral Tablet (BID)
|
Placebo
n=1 Participants
Placebo pill (BID)
Placebo oral tablet: Placebo Oral Tablet (BID)
|
|---|---|---|
|
Laboratory Alcohol Consumption
|
6 drinks
|
4 drinks
|
SECONDARY outcome
Timeframe: Laboratory session following 7 days of medication or laboratory session following 7 days of placebo pillsPopulation: The trial was halted after randomizing the first two participants. Only one participant completed the dependent measures.
Maximum self-reported stimulation during alcohol self-administration, as measured by the Brief Biphasic Alcohol Effects Scale. The final reported score is the sum of each item in the stimulation scale divided by the total number of items (3). The range of scores is 0-10, with higher numbers indicating higher subjective stimulation from alcohol.
Outcome measures
| Measure |
Lorcaserin
n=1 Participants
Lorcaserin (10mg BID)
Lorcaserin Oral Tablet: Lorcasering 10mg Oral Tablet (BID)
|
Placebo
n=1 Participants
Placebo pill (BID)
Placebo oral tablet: Placebo Oral Tablet (BID)
|
|---|---|---|
|
Subjective Responses to Alcohol
|
3 score on a scale
|
.33 score on a scale
|
SECONDARY outcome
Timeframe: Laboratory session following 7 days of medication or laboratory session following 7 days of placebo pills.Population: The trial was halted after randomizing the first two participants. Only one participant completed the dependent measures.
Self-reported alcohol demand, as measured by elasticity in the Alcohol Purchase Task. Elasticity was computed according to Jacobs \& Bickel (1999), using the estimated parameters a and b from the equation ln C = ln L + b(ln P) - aP, where C is number of drinks that would be consumed at price P, and L is a constant that represents the number of drinks consumed at P = 1. Overall elasticity is determined by computing elasticity (a-b(P)) for each price/consumption pair and taking the mean. Greater values of elasticity (i.e., less negative in this case) indicate increased willingness to consume the same number of drinks even as the price increases.
Outcome measures
| Measure |
Lorcaserin
n=1 Participants
Lorcaserin (10mg BID)
Lorcaserin Oral Tablet: Lorcasering 10mg Oral Tablet (BID)
|
Placebo
n=1 Participants
Placebo pill (BID)
Placebo oral tablet: Placebo Oral Tablet (BID)
|
|---|---|---|
|
Motivation to Consume Alcohol
|
-1.685 elasticity
|
-1.682 elasticity
|
SECONDARY outcome
Timeframe: Laboratory session following 7 days of medication or laboratory session following 7 days of placebo pills.Population: The trial was halted after randomizing the first two participants. Only one participant completed the dependent measures.
Self-reported cigarette demand, as measured by elasticity in the Cigarette Purchase Task. Elasticity was computed according to Jacobs \& Bickel (1999), using the estimated parameters a and b from the equation ln C = ln L + b(ln P) - aP, where C is number of cigarettes that would be purchased at price P, and L is a constant that represents the number of cigarettes purchased at P = 1. Overall elasticity is determined by computing elasticity (a-b(P)) for each price/consumption pair and taking the mean. Greater values of elasticity (i.e., less negative in this case) indicate increased willingness to purchase the same number of cigarettes even as the price increases.
Outcome measures
| Measure |
Lorcaserin
n=1 Participants
Lorcaserin (10mg BID)
Lorcaserin Oral Tablet: Lorcasering 10mg Oral Tablet (BID)
|
Placebo
n=1 Participants
Placebo pill (BID)
Placebo oral tablet: Placebo Oral Tablet (BID)
|
|---|---|---|
|
Motivation to Smoke Cigarettes
|
-1.540 elasticity
|
-1.682 elasticity
|
SECONDARY outcome
Timeframe: During 7 days of medication or during 7 days of placebo pills.Population: The trial was halted after randomizing the first two participants. Only one participant completed the dependent measures.
Self-reported drinks per drinking day
Outcome measures
| Measure |
Lorcaserin
n=1 Participants
Lorcaserin (10mg BID)
Lorcaserin Oral Tablet: Lorcasering 10mg Oral Tablet (BID)
|
Placebo
n=1 Participants
Placebo pill (BID)
Placebo oral tablet: Placebo Oral Tablet (BID)
|
|---|---|---|
|
Daily Alcohol Consumption
|
10.6 Drinks per drinking day
|
11 Drinks per drinking day
|
SECONDARY outcome
Timeframe: During 7 days of medication or during 7 days of placebo pills.Population: The trial was halted after randomizing the first two participants. Only one participant completed the dependent measures.
Number of cigarettes smoked per day
Outcome measures
| Measure |
Lorcaserin
n=1 Participants
Lorcaserin (10mg BID)
Lorcaserin Oral Tablet: Lorcasering 10mg Oral Tablet (BID)
|
Placebo
n=1 Participants
Placebo pill (BID)
Placebo oral tablet: Placebo Oral Tablet (BID)
|
|---|---|---|
|
Cigarette Consumption
|
11.4 cigarettes per day
|
12 cigarettes per day
|
Adverse Events
Lorcaserin
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place