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New treatment option for Alcohol Use, Unspecified
Official title ANCHORS Alcohol & Sexual Health Study: UH3 Project
ClinicalTrials.gov ID: NCT04331704
What this study is testing
What is PrEP acronym (pre-exposure prophylaxis)?
PrEP acronym (pre-exposure prophylaxis) is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for alcohol use, unspecified.
Also referred to as emtricitabine/tenofovir disoproxil fumarate.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 80 young adult men will complete an initial survey and receive 1 of 2 types of alcohol and sexual health education and information to encourage prevention of alcohol-related problems, HIV and other sexually transmitted infections (STIs). Participants will then take pre-exposure prophylaxis (PrEP) for HIV prevention and complete a daily 5-minute, telephone-based interactive voice response (IVR) assessment of alcohol/substance use, sexual behavior and PrEP taking for 30 days.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 30, men only. Healthy volunteers may be eligible.
You may be able to join if
- Ability to read and write English
- Consumption of 5 or more drinks per drinks in a day at least once in the past 30-days
- Sexual intercourse with another man without condom use at least once in the past 30 days
- HIV seronegative at medical screening
- Report currently taking PrEP willingness to take PrEP
You likely can't join if
- History of clinically significant withdrawal from alcohol, defined as any one of the following: a) a lifetime history of seizures, delirium, or...
- Self report injection drug use
- DSM-5 criteria for moderate or severe current substance use disorder besides alcohol and nicotine.
- Serious psychiatric symptoms
- Use of medications that interfere with PrEP including diuretics, nephrotoxic drugs, non-steroidal anti-inflammatory drugs, antiretroviral drugs or...
- Active hepatitis B infection
See the full eligibility criteria
- Ability to read and write English
- Consumption of 5 or more drinks per drinks in a day at least once in the past 30-days
- Sexual intercourse with another man without condom use at least once in the past 30 days
- HIV seronegative at medical screening
- Report currently taking PrEP willingness to take PrEP
- History of clinically significant withdrawal from alcohol, defined as any one of the following: a) a lifetime history of seizures, delirium, or hallucinations during alcohol withdrawal; b) a Clinical Institute...
- Self report injection drug use
- DSM-5 criteria for moderate or severe current substance use disorder besides alcohol and nicotine.
- Serious psychiatric symptoms
- Use of medications that interfere with PrEP including diuretics, nephrotoxic drugs, non-steroidal anti-inflammatory drugs, antiretroviral drugs or other drugs that may interfere with tenofovir excretion
- Active hepatitis B infection
- The following medical exclusions: serious or life-threatening conditions; inadequate biochemical, hepatic, hematologic, or pancreatic function according to laboratory testing
- Participant reports currently taking injectable PrEP
The study team makes the final eligibility decision.
Where it's taking place
- Gainesville, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 18 years to 30 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gainesville, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.