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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
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Glenn-Milo Santos, University of California, San Francisco

Brief Summary:
This project is a placebo-controlled, double-blind randomized trial evaluating the feasibility, tolerability, acceptability and adherence for lorcaserin among actively using, men who have sex with men (MSM) with cocaine use disorders.The study will enroll 45 individuals who will randomly be assigned to either the treatment (lorcaserin) arm or the placebo arm, to be taken twice a day for 12 weeks.

Condition or disease Intervention/treatment Phase
Cocaine Use Disorder Drug: lorcaserin Drug: Placebo Oral Tablet Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Lorcaserin

Arm Intervention/treatment
Active Comparator: Experimental
lorcaserin, extended release
Drug: lorcaserin
lorcaserin 20 mg tablet
Other Name: BELVIQ

Placebo Comparator: Control
Placebo
Drug: Placebo Oral Tablet
placebo 20 mg. tablet
Other Name: Placebo




Primary Outcome Measures :
  1. 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;

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male gender assigned at birth and transgender men;
  • self-reported anal intercourse with men in the prior six months while under the influence of cocaine;
  • cocaine use disorder by DSM-V SCID criteria;
  • current cocaine use confirmed by urinalysis and cocaine use at least 15 days in the past 30 days;
  • HIV-negative by rapid test or HIV-positive with a medical record of HIV infection;
  • no current acute illnesses requiring prolonged medical care;
  • no chronic illnesses that are likely to progress clinically during trial;
  • able and willing to provide informed consent and adhere to visit schedule;
  • age 18-65 years;
  • baseline CBC, total protein, albumin, glucose, alkaline phosphatase, creatinine, BUN, and electrolytes without clinically significant abnormalities as determined by study clinician in conjunction with symptoms, physical exam, and medical history

Exclusion Criteria:

  • Any psychiatric condition (e.g., depression with suicidal ideation, schizophrenia) or medical condition that would preclude safe study participation;
  • HIV-positive test result at screening visit but previously unaware of HIV infection (i.e., newly diagnosed with HIV infection at screening; those with a medical record of HIV infection are eligible);
  • any moderate to severe alcohol or substance use disorders (other than cocaine use disorders), according to DSM-V criteria;
  • known allergy or previous adverse reaction to lorcaserin;
  • current CD4 count < 200 cells/mm3 ;
  • moderate/sever liver disease (AST, ALT > 3 times upper limit or normal);
  • severely impaired renal function (creatinine clearance £ 30 ml/min);
  • use of medications that affect the serotonergic neurotransmitter system (e.g., selective serotonin reuptake inhibitors (SSRIs), selective serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs));
  • predisposition to priapism;
  • currently participating in another longitudinal intervention research study;
  • body mass index (BMI) < 15; or ≥ 30 with desire to use weight management medication, or BMI > 35;
  • anticipated use of agents that are associated with valvulopathy and/or pulmonary hypertension
  • Are currently treated with an opiate-substitute (buprenorphine or methadone) maintenance treatment or received therapy with any opiate-substitute within 30 days preceding screening
  • Currently in court-mandated cocaine use treatment;
  • Had previous history of suicidal behavior in the last 12 months ("yes" answer to the suicidal behavior question 6 of the Columbia-Suicide Severity Rating Scale (C-SSRS)); or currently have suicidal ideation as determined by 'yes' answers to questions 4 or 5 on the C-SSRS administered by a study clinician;
  • Any physical condition affecting drug absorption (e.g., gastrectomy);
  • 12-lead ECG demonstrating QTc > 450 or a QRS interval > 120 msec at screening. If QTcF exceeds 450 msec, or QRS exceeds 120 msec, the ECG should be repeated two more times and the average of the three QTc values should be used to determine the subject's eligibility.

(Note: Participants newly diagnosed with HIV at screening who consent to be contacted for re-screening will be called in the subsequent month, or later, depending on participant preference).


Information from the National Library of Medicine

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


Locations
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United States, California
San Francisco Department of Public Health
San Francisco, California, United States, 94102
Sponsors and Collaborators
Glenn-Milo Santos
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Glenn-Milo Santos, PhD, MPH University of California, San Francisco
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Glenn-Milo Santos, Senior Research Scientist, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03192995    
Other Study ID Numbers: 17-21502
1R34DA042161 ( U.S. NIH Grant/Contract )
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: May 21, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Glenn-Milo Santos, University of California, San Francisco:
HIV
sexual behavior