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Trial record 10 of 48 for:    Lorcaserin

Treatment With Lorcaserin for Cocaine Use: The TLC Study (TLC)

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ClinicalTrials.gov Identifier: NCT03192995
Recruitment Status : Recruiting
First Posted : June 20, 2017
Last Update Posted : March 5, 2018
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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 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
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: lorcaserin Drug: 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




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 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 enrolled among those eligible.

  3. 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 study completion rate.

  4. 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.

  5. 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.

  6. 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.

  7. Medication adherence to study drug (MEMs cap) [ Time Frame: 12 weeks ]
    To evaluate the adherence of lorcaserin vs. placebo, the investigators will measure adherence looking at patterns of adherence.

  8. Medication adherence to study drug (MEMs cap) [ Time Frame: 12 weeks ]
    To evaluate the adherence of lorcaserin vs. placebo, the investigators will measure adherence documenting time to discontinuing medication.



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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


Contacts
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Contact: Glenn-Milo Santos, PhD, MPH 415-437-6231 glenn-milo.santos@sfdph.org
Contact: Jaclyn Hern, MPH 415-437-6276 Jaclyn.hern@sfdph.org

Locations
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United States, California
San Francisco Dept of Public Health Recruiting
San Francisco, California, United States, 94102
Contact: Jaclyn Hern    415-437-6276    Jaclyn.hern@sfdph.org   
Sponsors and Collaborators
University of California, San Francisco
National Institute on Drug Abuse (NIDA)

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Responsible Party: Glenn-Milo Santos, Senior Research Scientist, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT03192995     History of Changes
Other Study ID Numbers: 17-21502
1R34DA042161 ( U.S. NIH Grant/Contract )
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: March 5, 2018
Last Verified: March 2018

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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
Additional relevant MeSH terms:
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Cocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents