Treatment With Lorcaserin for Cocaine Use: The TLC Study (TLC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03192995|
Recruitment Status : Terminated (FDA alert regarding study drug safety)
First Posted : June 20, 2017
Last Update Posted : September 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Cocaine Use Disorder||Drug: lorcaserin Drug: Placebo Oral Tablet||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Treatment With Lorcaserin for Cocaine Use: The TLC Study|
|Actual Study Start Date :||January 1, 2018|
|Actual Primary Completion Date :||February 28, 2020|
|Actual Study Completion Date :||June 30, 2020|
|Active Comparator: lorcaserin||
lorcaserin 10 mg tablets taken orally twice daily
Other Name: BELVIQ
|Placebo Comparator: Placebo||
Drug: Placebo Oral Tablet
placebo tablets taken orally twice daily
- Number of people who were recruited and retained (descriptive) [ Time Frame: 12 weeks ]To determine the feasibility of enrolling and retaining individuals on lorcaserin vs. placebo, the investigators will calculate the number of those eligible among those screened;
- Number of adverse clinical events in the lorcaserin and placebo arms (descriptive) [ Time Frame: 12 weeks ]To explore the tolerability of lorcaserin vs. placebo the investigators will compute the number of those experiencing adverse events, both overall and by type.
- Challenges of medication adherence (questionnaire) [ Time Frame: 12 weeks ]To assess acceptability for lorcaserin vs. placebo the investigators will conduct in-depth, semi-structured qualitative interviews.
- Medication adherence to study drug (MEMs cap) [ Time Frame: 12 weeks ]To evaluate the adherence of lorcaserin vs. placebo, the investigators will measure adherence as the percent of doses taken overall.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03192995
|United States, California|
|San Francisco Department of Public Health|
|San Francisco, California, United States, 94102|