Trial Outcomes & Findings for Treatment With Lorcaserin for Cocaine Use: The TLC Study (NCT NCT03192995)
NCT ID: NCT03192995
Last Updated: 2023-08-14
Results Overview
To determine the feasibility of retaining individuals on lorcaserin vs. placebo, the investigators have calculated the mean weekly percentage of follow-up visits of those randomized in the study
TERMINATED
PHASE2
22 participants
12 weeks
2023-08-14
Participant Flow
On 2/13/2020, the Food and Drug Administration (FDA) issued a safety alert after concluding the assessment of the long-term safety of lorcaserin in CAMELLIA clinical trial among 6,000 participants who took lorcaserin for over 4.3 years and were overweight or obese, with cardiovascular disease. The analysis showed an increased risk of cancer. In response to the safety alert, active participants in our study were instructed to stop study medication use and informed of the FDA safety alert.
Participant milestones
| Measure |
Experimental
lorcaserin, extended release
lorcaserin: lorcaserin 20 mg tablet
|
Control
Placebo
Placebo Oral Tablet: placebo 20 mg. tablet
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
6
|
|
Overall Study
COMPLETED
|
16
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment With Lorcaserin for Cocaine Use: The TLC Study
Baseline characteristics by cohort
| Measure |
Treatment
n=16 Participants
lorcaserin, extended release
lorcaserin: lorcaserin 20 mg tablet
|
Control
n=6 Participants
Placebo
Placebo Oral Tablet: placebo 20 mg. tablet
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36 years
n=99 Participants
|
40 years
n=107 Participants
|
39 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
19 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
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 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
|
5 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 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
|
16 participants
n=99 Participants
|
6 participants
n=107 Participants
|
22 participants
n=206 Participants
|
|
Ever Received Cocaine Treatment
|
6 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: The Food and Drug Administration (FDA) issued an early termination of this study after concluding the assessment in the long-term safety of lorcaserin in another clinical trial among obese, cardiovascular patients who had been taking lorcaserin for an average of 4.3 years. At the time of early termination, we had enrolled a total of 22 participants and this is why the overall number varies for this analysis.
To determine the feasibility of retaining individuals on lorcaserin vs. placebo, the investigators have calculated the mean weekly percentage of follow-up visits of those randomized in the study
Outcome measures
| Measure |
Mean Percent of Weekly Follow-up Visits by Treatment and Control Arms
n=22 Participants
Weekly Retention of randomized study participants by lorcaserin and placebo arms
|
Control Group
Placebo
Placebo Oral Tablet: placebo 20 mg. tablet
|
|---|---|---|
|
Mean Percentage of Weekly Follow-up Visits of Randomized Study Participants
Treatment Group
|
83 mean percent of visit retention
Standard Deviation 22
|
—
|
|
Mean Percentage of Weekly Follow-up Visits of Randomized Study Participants
Control Group
|
81 mean percent of visit retention
Standard Deviation 26
|
—
|
PRIMARY outcome
Timeframe: 12 weeksTo explore the tolerability of lorcaserin vs. placebo the investigators will compute the number of adverse events, both overall and by type. A participant could have more than one AE.
Outcome measures
| Measure |
Mean Percent of Weekly Follow-up Visits by Treatment and Control Arms
n=15 Adverse Events
Weekly Retention of randomized study participants by lorcaserin and placebo arms
|
Control Group
n=7 Adverse Events
Placebo
Placebo Oral Tablet: placebo 20 mg. tablet
|
|---|---|---|
|
Adverse Clinical Events in the Lorcaserin and Placebo Arms (Descriptive)
Diarrhea
|
3 Adverse Events
|
0 Adverse Events
|
|
Adverse Clinical Events in the Lorcaserin and Placebo Arms (Descriptive)
Other
|
2 Adverse Events
|
4 Adverse Events
|
|
Adverse Clinical Events in the Lorcaserin and Placebo Arms (Descriptive)
Hyperglycemia
|
3 Adverse Events
|
1 Adverse Events
|
|
Adverse Clinical Events in the Lorcaserin and Placebo Arms (Descriptive)
Coughing
|
2 Adverse Events
|
1 Adverse Events
|
|
Adverse Clinical Events in the Lorcaserin and Placebo Arms (Descriptive)
Abdominal Pain
|
2 Adverse Events
|
1 Adverse Events
|
|
Adverse Clinical Events in the Lorcaserin and Placebo Arms (Descriptive)
Rash
|
3 Adverse Events
|
0 Adverse Events
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: MEMS Cap openings will track daily adherence; each dispenser opening is recorded as a medication event sent to a remote database in real time. The MEMs Cap openings will be calculated as the proportion of MEMs Cap opening over the number of days since enrollment.
To evaluate the adherence of lorcaserin vs. placebo, the investigators measured adherence as the frequency of taking the study drug as measured by the number of MEMS cap openings (wireless medication monitoring devices that record each opening as a real-time medication event). Cumulative percent adherence was calculated by dividing the frequency of openings at a given time point divided by the number of days since baseline.
Outcome measures
| Measure |
Mean Percent of Weekly Follow-up Visits by Treatment and Control Arms
n=16 Participants
Weekly Retention of randomized study participants by lorcaserin and placebo arms
|
Control Group
n=6 Participants
Placebo
Placebo Oral Tablet: placebo 20 mg. tablet
|
|---|---|---|
|
Cumulative Percent Adherence of Medication Events Monitoring (MEMs) Cap
|
51.6 percent adherence
Standard Deviation 27.7
|
66.2 percent adherence
Standard Deviation 21.7
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: The Food and Drug Administration (FDA) issued an early termination of this study after concluding the assessment in the long-term safety of lorcaserin in another clinical trial among obese, cardiovascular patients who had been taking lorcaserin for an average of 4.3 years. At the time of early termination, we had enrolled a total of 22 participants and this is why the overall number varies for this analysis.
The outcome measure determines the proportion of self-reported past week cocaine use by Time-Line-Follow-back (TLFB) among lorcaserin and placebo groups at Baseline and at 12 weeks.
Outcome measures
| Measure |
Mean Percent of Weekly Follow-up Visits by Treatment and Control Arms
n=16 Participants
Weekly Retention of randomized study participants by lorcaserin and placebo arms
|
Control Group
n=6 Participants
Placebo
Placebo Oral Tablet: placebo 20 mg. tablet
|
|---|---|---|
|
Proportion of Self-reported Past Week Cocaine Use Among Lorcaserin and Placebo Groups at Baseline and at 12 Weeks
Proportion of self-reported weekly cocaine use by TLFU at Week 12
|
7 Participants
|
6 Participants
|
|
Proportion of Self-reported Past Week Cocaine Use Among Lorcaserin and Placebo Groups at Baseline and at 12 Weeks
Proportion of self-reported weekly cocaine use by Time-Line-Follow-Up (TLFU) at baseline
|
12 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: At baseline, we had 16 participants in the lorcaserin arm and 6 in the placebo arm. 8 participants in the lorcaserin arm and no participants in the placebo arm tested positive for cocaine use disorder cocaine use disorder (CUD). At week 12, four participants lost to follow-up (LTFU) in the lorcaserin arm and 1 LTFU in the placebo arm, thus causing a difference in the overall number analyzed at week 12.
The outcome measure determines the proportion of urine-positive samples with cocaine positivity among lorcaserin and placebo groups at Baseline and at Week 12
Outcome measures
| Measure |
Mean Percent of Weekly Follow-up Visits by Treatment and Control Arms
n=16 Participants
Weekly Retention of randomized study participants by lorcaserin and placebo arms
|
Control Group
n=6 Participants
Placebo
Placebo Oral Tablet: placebo 20 mg. tablet
|
|---|---|---|
|
Proportion of Urine-positive Samples With Cocaine Positivity Among Lorcaserin and Placebo Groups at Baseline and at Week 12
Urine positive samples with cocaine use at baseline
|
8 Participants
|
0 Participants
|
|
Proportion of Urine-positive Samples With Cocaine Positivity Among Lorcaserin and Placebo Groups at Baseline and at Week 12
Urine positive samples with cocaine use at Week 12
|
7 Participants
|
1 Participants
|
Adverse Events
Experimental
Control
Serious adverse events
| Measure |
Experimental
n=16 participants at risk
lorcaserin, extended release
lorcaserin: lorcaserin 20 mg tablet
|
Control
n=6 participants at risk
Placebo
Placebo Oral Tablet: placebo 20 mg. tablet
|
|---|---|---|
|
Hepatobiliary disorders
Plasma Alanine aminotransferase level and plasma aspartate aminotransferase levels
|
0.00%
0/16 • After baseline, Adverse event data were collected weekly over the 12 week period of the study.
|
16.7%
1/6 • Number of events 1 • After baseline, Adverse event data were collected weekly over the 12 week period of the study.
|
|
Musculoskeletal and connective tissue disorders
Abscess of Hip
|
6.2%
1/16 • Number of events 1 • After baseline, Adverse event data were collected weekly over the 12 week period of the study.
|
0.00%
0/6 • After baseline, Adverse event data were collected weekly over the 12 week period of the study.
|
Other adverse events
| Measure |
Experimental
n=16 participants at risk
lorcaserin, extended release
lorcaserin: lorcaserin 20 mg tablet
|
Control
n=6 participants at risk
Placebo
Placebo Oral Tablet: placebo 20 mg. tablet
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
18.8%
3/16 • Number of events 3 • After baseline, Adverse event data were collected weekly over the 12 week period of the study.
|
0.00%
0/6 • After baseline, Adverse event data were collected weekly over the 12 week period of the study.
|
|
Gastrointestinal disorders
abdominal pain
|
12.5%
2/16 • Number of events 2 • After baseline, Adverse event data were collected weekly over the 12 week period of the study.
|
16.7%
1/6 • Number of events 1 • After baseline, Adverse event data were collected weekly over the 12 week period of the study.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
6.2%
1/16 • Number of events 1 • After baseline, Adverse event data were collected weekly over the 12 week period of the study.
|
16.7%
1/6 • Number of events 1 • After baseline, Adverse event data were collected weekly over the 12 week period of the study.
|
|
Gastrointestinal disorders
Decreased appetite
|
12.5%
2/16 • Number of events 2 • After baseline, Adverse event data were collected weekly over the 12 week period of the study.
|
0.00%
0/6 • After baseline, Adverse event data were collected weekly over the 12 week period of the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
18.8%
3/16 • Number of events 3 • After baseline, Adverse event data were collected weekly over the 12 week period of the study.
|
0.00%
0/6 • After baseline, Adverse event data were collected weekly over the 12 week period of the study.
|
|
General disorders
Flu-like symptoms
|
0.00%
0/16 • After baseline, Adverse event data were collected weekly over the 12 week period of the study.
|
33.3%
2/6 • Number of events 2 • After baseline, Adverse event data were collected weekly over the 12 week period of the study.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
18.8%
3/16 • Number of events 3 • After baseline, Adverse event data were collected weekly over the 12 week period of the study.
|
16.7%
1/6 • Number of events 1 • After baseline, Adverse event data were collected weekly over the 12 week period of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Coughing
|
12.5%
2/16 • Number of events 2 • After baseline, Adverse event data were collected weekly over the 12 week period of the study.
|
16.7%
1/6 • Number of events 1 • After baseline, Adverse event data were collected weekly over the 12 week period of the study.
|
Additional Information
Dr. Glenn-Milo Santos, Associate Professor
University of California at San Francisco
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place