Trial · NCT03192995
Treatment With Lorcaserin for Cocaine Use: The TLC Study
NCT03192995, Phase 2, Terminated, Glenn-Milo Santos; results first posted 2023-08-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Treatment With Lorcaserin for Cocaine Use: The TLC Study. Trials, record NCT03192995. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03192995
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment With Lorcaserin for Cocaine Use: The TLC Study
- NCT number
- NCT03192995
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 22 participants, actual
- Lead sponsor
- Glenn-Milo Santos
- Conditions
- Cocaine Use Disorder
- Interventions
- lorcaserin, Placebo Oral Tablet, Substance use counseling, ACASI, Cocaine metabolites, Ecological Momentary Assessment (EMA), Balloon Analogue Risk Task (BART), Qualitative Exit Interview
- First posted
- 2017-06-20
- Last updated
- 2023-08-14
- Results first posted
- 2023-08-14
- Limitations and caveats
- The study was terminated early by the FDA due to the publication of a long-term safety study that showed an increase risk for cancer by the lorcaserin arm.
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Percentage of Weekly Follow-up Visits of Randomized Study Participants | 12 weeks | 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 |
| Primary | Adverse Clinical Events in the Lorcaserin and Placebo Arms (Descriptive) | 12 weeks | To 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. |
| Primary | Cumulative Percent Adherence of Medication Events Monitoring (MEMs) Cap | 12 weeks | 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. |
| Primary | Proportion of Self-reported Past Week Cocaine Use Among Lorcaserin and Placebo Groups at Baseline and at 12 Weeks | 12 weeks | 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. |
| Primary | Proportion of Urine-positive Samples With Cocaine Positivity Among Lorcaserin and Placebo Groups at Baseline and at Week 12 | 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 |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Percentage of Weekly Follow-up Visits of Randomized Study Participants | 12 weeks | 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. | mean percent of visit retention | MEAN |
| PRIMARY | Adverse Clinical Events in the Lorcaserin and Placebo Arms (Descriptive) | 12 weeks | Adverse Events | COUNT_OF_UNITS | |
| PRIMARY | Cumulative Percent Adherence of Medication Events Monitoring (MEMs) Cap | 12 weeks | 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. | percent adherence | MEAN |
| PRIMARY | Proportion of Self-reported Past Week Cocaine Use Among Lorcaserin and Placebo Groups at Baseline and at 12 Weeks | 12 weeks | 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. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Proportion of Urine-positive Samples With Cocaine Positivity Among Lorcaserin and Placebo Groups at Baseline and at Week 12 | Week 12 | 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. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Percentage of Weekly Follow-up Visits of Randomized Study Participants | Mean Percent of Weekly Follow-up Visits by Treatment and Control Arms | Treatment Group | 83 | Standard Deviation 22 | mean percent of visit retention |
| Mean Percentage of Weekly Follow-up Visits of Randomized Study Participants | Mean Percent of Weekly Follow-up Visits by Treatment and Control Arms | Control Group | 81 | Standard Deviation 26 | mean percent of visit retention |
| Adverse Clinical Events in the Lorcaserin and Placebo Arms (Descriptive) | Treatment Group | Hyperglycemia | 3 | Adverse Events | |
| Adverse Clinical Events in the Lorcaserin and Placebo Arms (Descriptive) | Control Group | Hyperglycemia | 1 | Adverse Events | |
| Adverse Clinical Events in the Lorcaserin and Placebo Arms (Descriptive) | Treatment Group | Coughing | 2 | Adverse Events | |
| Adverse Clinical Events in the Lorcaserin and Placebo Arms (Descriptive) | Control Group | Coughing | 1 | Adverse Events | |
| Adverse Clinical Events in the Lorcaserin and Placebo Arms (Descriptive) | Treatment Group | Abdominal Pain | 2 | Adverse Events | |
| Adverse Clinical Events in the Lorcaserin and Placebo Arms (Descriptive) | Control Group | Abdominal Pain | 1 | Adverse Events | |
| Adverse Clinical Events in the Lorcaserin and Placebo Arms (Descriptive) | Treatment Group | Rash | 3 | Adverse Events | |
| Adverse Clinical Events in the Lorcaserin and Placebo Arms (Descriptive) | Control Group | Rash | 0 | Adverse Events |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Experimental | 16 | |
| Overall Study | STARTED | Control | 6 | |
| Overall Study | COMPLETED | Experimental | 16 | |
| Overall Study | COMPLETED | Control | 6 | |
| Overall Study | NOT COMPLETED | Experimental | 0 | |
| Overall Study | NOT COMPLETED | Control | 0 |
Source ClinicalTrials.gov
Adverse events20
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhea | Gastrointestinal disorders | Experimental | 3 | 16 | 3 |
| other | Diarrhea | Gastrointestinal disorders | Control | 0 | 6 | 0 |
| other | abdominal pain | Gastrointestinal disorders | Experimental | 2 | 16 | 2 |
| other | abdominal pain | Gastrointestinal disorders | Control | 1 | 6 | 1 |
| other | Hypoglycemia | Metabolism and nutrition disorders | Experimental | 1 | 16 | 1 |
| other | Hypoglycemia | Metabolism and nutrition disorders | Control | 1 | 6 | 1 |
| other | Decreased appetite | Gastrointestinal disorders | Experimental | 2 | 16 | 2 |
| other | Decreased appetite | Gastrointestinal disorders | Control | 0 | 6 | 0 |
| other | Rash | Skin and subcutaneous tissue disorders | Experimental | 3 | 16 | 3 |
| other | Rash | Skin and subcutaneous tissue disorders | Control | 0 | 6 | 0 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Experimental | 0 | 16 |
| Total, all-cause mortality | Control | 0 | 6 |
| Total, other adverse events | Experimental | 16 | 16 |
| Total, other adverse events | Control | 6 | 6 |
| Total, serious adverse events | Experimental | 1 | 16 |
| Total, serious adverse events | Control | 1 | 6 |
Source ClinicalTrials.gov
Papers73
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R34DA042161 | Treatment with Lorcaserin for Cocaine Use - The TLC Study | SANTOS, GLENN-MILO | UNIVERSITY OF CALIFORNIA, SAN FRANCISCO | NATIONAL INSTITUTE ON DRUG ABUSE | 2017 to 2019 |
Source NIH RePORTER
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Experimental vs Control: deaths from any cause | Trial comparisons |
| Experimental vs Control: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03192995
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