Treatment With Lorcaserin for Cocaine Use: The TLC Study

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.

Conditions

• Cocaine Use Disorder

Interventions

DRUG

lorcaserin

lorcaserin 20 mg tablet

DRUG

Placebo Oral Tablet

placebo 20 mg. tablet

BEHAVIORAL

Substance use counseling

Manual-driven psychosocial substance use counseling program using cognitive behavioral therapy and motivational interviewing techniques and incorporating the Stages of Change Model.

BEHAVIORAL

ACASI

Audio-computer assisted self-interviews (ACASI) is a self-administered standardized questionnaire on substance and alcohol use, substance use treatment, sexual risk behavior, partnership sexual risk, and

DIAGNOSTIC_TEST

Cocaine metabolites

Rapid qualitative urine test Medtox Verdict II (Medtox Diagnostics, Burlington, NC) and tamper-evident sweat patches (PharmChek®, PharmChem, Inc., Fort Worth, Tx)

BEHAVIORAL

Ecological Momentary Assessment (EMA)

EMA are questions sent to the participant 4-5 times a day to determine real-time behavior and participant experiences.

BEHAVIORAL

Balloon Analogue Risk Task (BART)

BART is a computerized measure of risk taking behavior. The BART models real-world risk behavior through the conceptual frame of balancing the potential for reward versus loss. This is a test for impulsivity.

BEHAVIORAL

Qualitative Exit Interview

The qualitative exit interview assessed acceptability measures and included questions on attitudes about trial participation, level of satisfaction with trial procedures, and trial medication.

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• Glenn-Milo Santos

  lead OTHER

Principal Investigators

• Glenn-Milo Santos, PhD, MPH · University of California, San Francisco

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-01-01

Primary Completion

2020-02-28

Completion

2020-06-30

FDA Drug

Yes

Countries

• United States

Study Locations