Treatment With Lorcaserin for Cocaine Use: The TLC Study (TLC)
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|ClinicalTrials.gov Identifier: NCT03192995|
Recruitment Status : Terminated (FDA alert regarding study drug safety)
First Posted : June 20, 2017
Last Update Posted : May 21, 2021
|Condition or disease||Intervention/treatment||Phase|
|Cocaine Use Disorder||Drug: lorcaserin Drug: Placebo Oral Tablet||Phase 2|
This is a randomized, double-blind, placebo-controlled, 12-week parallel group pilot study with 2:1 random assignment to 20 mg of extended-release oral lorcaserin versus placebo. Participants are recruited via street outreach, recruitment flyers, STD and HIV clinics, needle exchanges, community organizations, MSM bars, online Web sites, and social media. Potential participants complete a brief telephone screen to assess initial eligibility and, if eligible, are scheduled for an in-person screening visit. All participants give informed consent using UCSF IRB-approved consent forms. A 10-item true/false questionnaire is used to verify participants' understanding of the trial. The target sample size for the study was 45 participants. With this sample size, we estimate that proportions for our feasibility and acceptability outcomes would be estimated within margins of sampling error (MSEs; i.e., half widths of 95% confidence intervals) of ≤14.4 percentage points, and means with MSEs of 0.30 standard deviations, both typical for a small pilot study.
Participants are screened for eligibility based on inclusion criteria. At Enrollment, participants are instructed to take one pill each day of extended-release lorcarserin 20mg or placebo. Medications are dispensed in bottles with MEMS caps, which are wireless medication monitoring devices that record each opening as a real-time medication event. All participants are asked about potential adverse events at each follow-up visit; symptom-driven physical exams and safety laboratory monitoring are done at weeks 4, 8, and 12. Adverse events are classified using the Division of AIDS (DAIDS) Table for Grading Severity of Adult Adverse Experiences for HIV Prevention Trials Network. Participants are seen every week for substance use counseling and urine tests for cocaine metabolites. Trained staff, supervised by a clinical psychologist, administered brief (20-30 minutes) substance use counseling at follow-up visits. Audio-computer assisted self-interviews (ACASI) are used to standardize data collection and minimize reporting bias.[63, 64] Standardized measures are used to assess drug and alcohol use using timeline followback, substance use treatment, craving and severity of cocaine dependence, and sexual risk behavior.[13, 65-67] Acceptability measures include questions on attitudes about trial participation, level of satisfaction with trial procedures, and trial medication.
|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: Experimental
lorcaserin, extended release
lorcaserin 20 mg tablet
Other Name: BELVIQ
Placebo Comparator: Control
Drug: Placebo Oral Tablet
placebo 20 mg. tablet
Other Name: Placebo
- 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|
|Principal Investigator:||Glenn-Milo Santos, PhD, MPH||University of California, San Francisco|