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New treatment option for Stimulant Use Disorder
Official title reSET for the Treatment of Stimulant Use in HIV Clinics: Care Optimization Supporting Treatment Adherence (COSTA)
ClinicalTrials.gov ID: NCT05958017
What this study is testing
- What it's testing
- The purpose of this study is to find out if reSET, an FDA authorized mobile therapeutic, is effective in treating stimulant use disorder and helping keep HIV viral load suppression stable among men who have sex with men who are living with HIV and have a stimulant use disorder.
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 90, men only
You may be able to join if
- Assigned male sex at birth and has not undergone any transgender hormonal treatment
- Reports having had sex with a male in the past 12 months
- Age 18 or older
- Is affiliated with a study referral source (e.g., AHF clinic, registry, other healthcare program or clinic) or resides in a city or county where a...
- Screens positive for mild, moderate or severe stimulant use disorder in the last 12 months using the MINI
You likely can't join if
- Patient appears to have diminished capacity to consent either because of cognitive impairment or severe psychiatric symptoms (e.g., mania, psychosis).
- Persons that meet criteria for prisoner status will be excluded at baseline.
- Patients who screen positive for moderate to severe opioid use disorder will be excluded from the study because effective pharmacological agents...
- Participants will be excluded prior to randomization, if they do not complete at baseline the Time-Line Follow-Back or the laboratory visit.
See the full eligibility criteria
- Assigned male sex at birth and has not undergone any transgender hormonal treatment
- Reports having had sex with a male in the past 12 months
- Age 18 or older
- Is affiliated with a study referral source (e.g., AHF clinic, registry, other healthcare program or clinic) or resides in a city or county where a participating healthcare center or health program is located
- Screens positive for mild, moderate or severe stimulant use disorder in the last 12 months using the MINI
- Reports that he is not currently in drug treatment
- Is living with HIV
- Reports having an active antiretroviral prescription
- Have access to a smartphone or tablet with stable internet at least twice a week and can download applications to the smartphone or tablet
- Able to understand English
- Consents to participation in the study
- Provides sufficient locator information
- Identifies as non-Hispanic White, non-Hispanic Black/African American or Latinx/Hispanic
- Has been in stable housing for the past 3 months and intends to remain housed for the next 15 months
- Patient appears to have diminished capacity to consent either because of cognitive impairment or severe psychiatric symptoms (e.g., mania, psychosis).
- Persons that meet criteria for prisoner status will be excluded at baseline.
- Patients who screen positive for moderate to severe opioid use disorder will be excluded from the study because effective pharmacological agents exist for the treatment of this disorder. These patients will be referred...
- Participants will be excluded prior to randomization, if they do not complete at baseline the Time-Line Follow-Back or the laboratory visit.
The study team makes the final eligibility decision.
Where it's taking place
- Miami, 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 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, 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.