PrEP for Drug Abuse

Phase-Based Estimates
3
Effectiveness
3
Safety
University of Miami, Miami, FL
Drug Abuse+2 More
PrEP - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Drug Abuse

Study Summary

This study is evaluating whether providing pre-exposure prophylaxis (PrEP) medicine right away at the IDEA Exchange will help participants remain in HIV negative.

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Eligible Conditions

  • Drug Abuse
  • Substance-Related Disorders
  • Hiv
  • Substance Use Disorders (SUD)

Treatment Effectiveness

Effectiveness Estimate

3 of 3
This is better than 93% of similar trials

Study Objectives

This trial is evaluating whether PrEP will improve 1 primary outcome and 1 secondary outcome in patients with Drug Abuse. Measurement will happen over the course of 6 months.

6 months
Intracellular level of tenofovir diphosphate
up to 12 months
time to PrEP initiation post negative HIV rapid test

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

2 Treatment Groups

Control
Rapid PrEP group

This trial requires 100 total participants across 2 different treatment groups

This trial involves 2 different treatments. PrEP is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 4 and have been shown to be safe and effective in humans.

Rapid PrEP groupParticipants will receive PrEP i.e. Descovy for 12 months at the syringe services program.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PrEP
2018
Completed Phase 4
~9130

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 12 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 12 months for reporting.

Who is running the study

Principal Investigator
H. T.
Prof. Hansel Tookes, Assistant Professor
University of Miami

Closest Location

University of Miami - Miami, FL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 6 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
This person has a negative result on an HIV rapid test. show original
This person has a creatinine clearance of more than 30 ml/minute, which is considered normal. show original
They must be over the age of 18 to vote. show original
You can either speak English or Spanish. show original
ability to provide informed consent
The person is currently enrolled in a syringe services program. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the signs of drug abuse?

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What can you tell your doctor about your drug use? The doctor will have many questions about your past and recent drug usage. The doctor will check your eyes, the muscles of your face and your mouth, as well as your ears, genitals, nails, and scalp for signs of drug use before deciding if drug addiction and addiction treatments are appropriate.\n

Unverified Answer

Can drug abuse be cured?

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It is the authors' contention that a variety of social and biomedical factors play important roles in drug abuse. Accordingly, we argue that, in order to cure drugs abuse, medical and scientific establishments should be integrated in the context of a coherent whole (an interdisciplinary approach). At the same time, we propose that a social, medical-educational approach can complement efforts to create an environment conducive for drug abuse, for example, by improving the access to rehabilitation and treatment, or by reducing the stigma toward drug users.

Unverified Answer

How many people get drug abuse a year in the United States?

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A significant number of US youth who abuse a variety of drugs might not initiate these practices voluntarily. The risk factors for initiation of drug abuse in this age group seem different from and may be independent of initiation of other forms of substance abuse.

Unverified Answer

What are common treatments for drug abuse?

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Alcoholism is treatable with a variety of psychotherapeutic measures. Alcohol cessation is possible with relapse of those who relapse and, depending on the duration and extent of relapsing, is a part of the management program. While long-term drug abuse can be treated with a variety of short- and medium-term measures, relapse is likely and may require a variety of treatments as well.

Unverified Answer

What is drug abuse?

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Drug abuse is a problem associated with mental, emotional, and physical disorders, which negatively impact quality of life and health. It is also a problem of social and economic importance. There are many ways users can limit their drug use and their addiction to illicit drugs.\n

Unverified Answer

What causes drug abuse?

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In this article, we explored why certain psychotherapies may increase risk of drug abuse, though for many drugs addiction is influenced by many different determinants such as the individual's personality traits and cultural values.

Unverified Answer

Is prep typically used in combination with any other treatments?

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Prep is used in many patients with advanced HIV with adverse effects in the skin, liver, GI tract, and musculoskeletal system. The most common adverse drug reactions reported in the patients receiving prep for the treatment of HIV were: hypersensitivity reactions, rash, and skin necrosis. In the patients who did not report skin irritation, there was only one case of an exacerbating hypersensitivity reaction. In patients who reported hypersensitivity reactions, all of the adverse reactions were mild. It is unclear from our study whether there is an increased rate of prep hypersensitivity reactions based on ethnicity.

Unverified Answer

Has prep proven to be more effective than a placebo?

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The present study shows that PPT proved to be more effective than a placebo in reducing withdrawal symptoms of opioid-addicted patients. The reason is not obvious and may involve the fact that the PPT had a positive effect on opioid-dependent patients on multiple levels of self measurement. Another reason may be due to the fact that PPT is perceived as not being too strongly aversive, which may reduce the risk of a withdrawal syndrome in the future.

Unverified Answer

What is prep?

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The impact of prenatal stress is complicated by its complex effects on multiple neural reward systems. Prenatal stress can both facilitate and suppress drug-seeking behavior in young adult rats. The effect of post-weaning stressors on reward signaling in the NAFC is not simple. Post-weaning SD exposure had a minimal effect on DA responses in the NAFC, with most changes to the reward system in the NAFC occurring after exposure to both SDs and chronic cocaine treatments in adulthood. Data from a recent study provide insight into the complex and plastic nature of the neurobiological interactions among stress, drug seeking, and reward circuitry in adolescent animals.

Unverified Answer

What are the common side effects of prep?

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Side effects associated with prep are common and have not resulted in an overall rise in side effects since the initial release of the drug. [Clinicaltrials.gov (NIH) as of 19 December 2010] Currently, prep is being used in the United States, United Kingdom, and elsewhere, and it is important that consumers know about the common side effects as well as what to expect with prep use.

Unverified Answer

What are the latest developments in prep for therapeutic use?

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The new drugs under investigation are not expected to change the course and the prognosis on ALFTM substantially, but may provide clinical information that may change the course of disease and influence the management of patients.

Unverified Answer

How does prep work?

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Prep administration facilitates completion of initial stages of initiation by suppressing the urge to use and by altering substance-related memory. This process is unlikely to reduce relapse risk and thus, prep does not help to prevent relapse.

Unverified Answer
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