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Stimulant

Oral Methamphetamine for HIV (EMRLHD Trial)

Phase 4

Waitlist Available

Led By Sulggi A Lee, MD PhD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 hours

Awards & highlights

EMRLHD Trial Summary

This trial will study the effects of short-term methamphetamine exposure in HIV-infected individuals on residual virus production, gene expression, and inflammation.

Eligible Conditions

Methamphetamine Addiction
HIV

EMRLHD Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

HIV transcription (cell-associated HIV RNA) in peripheral blood

Secondary outcome measures

Host gene expression (RNA sequencing) in peripheral blood

Systemic inflammation (plasma pro-inflammatory cytokine levels)

Trace amine receptor 1 (TAAR1) signaling metabolite levels in in peripheral blood

EMRLHD Trial Design

2Treatment groups

Experimental Treatment

Group I: Placebo oral capsule, Then Oral methamphetamineExperimental Treatment2 Interventions

Participants will be randomized to a placebo oral capsule first, then oral methamphetamine using a random number generator. For the placebo treatment, one placebo capsule will be administered orally on treatment day, followed by a second oral placebo capsule two hours later. Then the participant will receive the oral methamphetamine capsule for their second treatment phase starting at approximately Day 77. When oral methamphetamine is administered, an initial 10 mg of oral methamphetamine study drug will be administered to assess tolerability, followed by a subsequent 15 mg oral dose two hours later.

Group II: Oral methamphetamine, Then Placebo oral capsuleExperimental Treatment2 Interventions

Participants will be randomized to oral methamphetamine first then placebo oral capsule using a random number generator. When oral methamphetamine is administered, an initial 10 mg of oral methamphetamine study drug will be administered to assess tolerability, followed by a subsequent 15 mg oral dose two hours later. Then the participant will receive the placebo oral capsule for their second treatment phase starting at approximately Day 77. For the placebo treatment, one placebo capsule will be administered orally on treatment day, followed by a second oral placebo capsule two hours later.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Oral Methamphetamine

2021

Completed Phase 4

~20

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH

2,465 Previous Clinical Trials

2,618,619 Total Patients Enrolled

University of California, San FranciscoLead Sponsor

2,503 Previous Clinical Trials

15,236,641 Total Patients Enrolled

Sulggi A Lee, MD PhDPrincipal InvestigatorUniversity of California, San Francisco

2 Previous Clinical Trials

16 Total Patients Enrolled

Frequently Asked Questions

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

Have any previous investigations employed Oral Methamphetamine?

"Currently, 5 clinical trials for Oral Methamphetamine are in progress with 0 studies at the Phase 3 stage. 8 different sites across America including Chicago, Illinois are hosting these investigations."

Answered by AI

How many participants are currently included in this clinical trial?

"Affirmative, the information on clinicaltrials.gov implies that this scientific research is actively enrolling patients. The posting of the trial was first made in January 1st 2021 and recently updated on March 22nd 2022. 10 individuals are sought out at a single location for this study."

Answered by AI

Is this experiment presently seeking participants?

"Affirmative. Clinicaltrials.gov reflects that the trial, originally posted on 1st January 2021 is still accepting patients. 10 participants are sought from a single medical facility."

Answered by AI

Does this clinical trial offer enrollment opportunities?

"Eligibility for this clinical trial requires HIV infection and an age between 18-65. Approximately 10 individuals will be accepted for the study's duration."

Answered by AI

Do younger individuals meet the criteria for inclusion in this research?

"This clinical trial has a patient inclusion criteria of 18-65 years old. Separately, there are 124 studies for minors below the age of consent and 435 specifically targeting elderly individuals above 65."

Answered by AI